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REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": {
"heading": "Subject matter and scope",
"text": "1.This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also appliesto clinical investigations concerning such medical devices and accessories conducted in the Union. 2. This Regulation shall also apply, as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI, taking into account the state of the art, and in particular existing harmonised standards for analogous devices with a medical purpose, based on similar technology. The common specifications for each of the groups of products listed in Annex XVI shall address, at least, application of risk management as set out in Annex I for the group of products in question and, where necessary, clinical evaluation regarding safety. The necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.Notwithstanding Article 122, Member States' measures regarding the qualification of the products covered by Annex XVI as medical devices pursuant to Directive 93/42/EEC shall remain valid until the date of application, as referred to in the first subparagraph, of the relevant common specifications for that group of products. This Regulation also applies to clinical investigations conducted in the Union concerning the products referred to in the first subparagraph. 3. Devices with both a medical and a non-medical intended purpose shall fulfil cumulatively the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose. 4.For the purposes of this Regulation, medical devices, accessories for medical devices, and products listed in Annex XVI to which this Regulation applies pursuant to paragraph 2 shall hereinafter be referred to as ‘devices’. 5. Where justified on account of the similarity between a device with an intended medical purpose placed on the market and a product without an intended medical purpose in respect of their characteristics and risks, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend the list in Annex XVI, by adding new groups of products, in order to protect the health and safety of users or other persons or other aspects of public health. 6. This Regulation does not apply to: (a) in vitro diagnostic medical devices covered by Regulation (EU) 2017/746; (b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product; (c) advanced therapy medicinal products covered by Regulation (EC) No 1394/2007; (d) human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article; (e) cosmetic products covered by Regulation (EC) No 1223/2009; (f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or are rendered non-viable; (g) transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable; (h) products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product; (i) food covered by Regulation (EC) No 178/2002. 7. Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by this Regulation. The requirements of Regulation (EU) 2017/746 shall apply to the in vitro diagnostic medical device part of the device. 8. Any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered to be a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma as defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the device, shall be assessed and authorised in accordance with this Regulation. However, if the action of that substance is principal and not ancillary to that of the device, the integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned. 9. Any device which is intended to administer a medicinal product as defined in point 2 of Article 1 of Directive 2001/83/EC shall be governed by this Regulation, without prejudice to the provisions of that Directive and of Regulation (EC) No 726/2004 with regard to the medicinal product. However, if the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product shall be governed by Directive 2001/83/EC or Regulation (EC) No 726/2004, as applicable. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part of the single integral product are concerned. 10. Any device which, when placed on the market or put into service, incorporates, as an integral part, non-viable tissues or cells of human origin or their derivatives that have an action ancillary to that of the device shall be assessed and authorised in accordance with this Regulation. In that case, the provisions for donation, procurement and testing laid down in Directive 2004/23/EC shall apply. However, if the action of those tissues or cells or their derivatives is principal and not ancillary to that of the device and the product is not governed by Regulation (EC) No 1394/2007, the product shall be governed by Directive 2004/23/EC. In that case, the relevant general safety and performance requirements set out in Annex I to this Regulation shall apply as far as the safety and performance of the device part are concerned. 11. This Regulation is specific Union legislation within the meaning of Article 2(3) of Directive 2014/30/EU. 12. Devices that are also machinery within the meaning of point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council (1) shall, where a hazard relevant under that Directive exists, also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those requirements are more specific than the general safety and performance requirements set out in Chapter II of Annex I to this Regulation. 13. This Regulation shall not affect the application of Directive 2013/59/Euratom. 14. This Regulation shall not affect the right of a Member State to restrict the use of any specific type of device in relation to aspects not covered by this Regulation. 15. This Regulation shall not affect national law concerning the organisation, delivery or financing of health services and medical care, such as the requirement that certain devices may only be supplied on a medical prescription, the requirement that only certain health professionals or healthcare institutions may dispense or use certain devices or that their use be accompanied by specific professional counselling. 16. Nothing in this Regulation shall restrict the freedom of the press or the freedom of expression in the media in so far as those freedoms are guaranteed in the Union and in the Member States, in particular under Article 11 of the Charter of Fundamental Rights of the European Union."
},
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": {
"heading": "Definitions",
"text": "For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, — diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, — investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, — providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: — devices for the control or support of conception; — products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point. (2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s); (3) ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's re sponsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices; (4) ‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device; (5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended: — to be totally introduced into the human body, or — to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device; (6) ‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body; (7) ‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics; (8) ‘single-use device’ means a device that is intended to be used on one individual during a single procedure; (9) ‘falsified device’ means any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include uninten tional non-compliance and is without prejudice to infringements of intellectual property rights; (10) ‘procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose; (11) ‘system’ means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose; (12) ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation; (13) ‘label’ means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices; (14) ‘instructions for use’ means the information provided by the manufacturer to inform the user of a device's intended purpose and proper use and of any precautions to be taken; (15) ‘Unique Device Identifier’ (‘UDI’) means a series of numeric or alphanumeric characters that is created through in ternationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market; (16) ‘non-viable’ means having no potential for metabolism or multiplication; (17) ‘derivative’ means a ‘non-cellular substance’ extracted from human or animal tissue or cells through a manufacturing process. The final substance used for manufacturing of the device in this case does not contain any cells or tissues; (18) ‘nanomaterial’ means a natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm; Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall also be deemed to be nanomaterials; (19) ‘particle’, for the purposes of the definition of nanomaterial in point (18), means a minute piece of matter with defined physical boundaries; (20) ‘agglomerate’, for the purposes of the definition of nanomaterial in point (18), means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; (21) ‘aggregate’, for the purposes of the definition of nanomaterial in point (18), means a particle comprising of strongly bound or fused particles; (22) ‘performance’ means the ability of a device to achieve its intended purpose as stated by the manufacturer; (23) ‘risk’ means the combination of the probability of occurrence of harm and the severity of that harm; (24) ‘benefit-risk determination’ means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer; (25) ‘compatibility’ is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to: (a) perform without losing or compromising the ability to perform as intended, and/or (b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or (c) be used together without conflict/interference or adverse reaction. (26) ‘interoperability’ is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to: (a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or (b) communicate with each other, and/or (c) work together as intended. (27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge; (28) ‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market; (29) ‘putting into service’ means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose; (30) ‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark; (31) ‘fully refurbishing’, for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device;(32) ‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation; (33) ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market; (34) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service; (35) ‘economic operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3); (36) ‘health institution’ means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health; (37) ‘user’ means any healthcare professional or lay person who uses a device; (38) ‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline; (39) ‘reprocessing’ means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device; (40) ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled; (41) ‘conformity assessment body’ means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection; (42) ‘notified body’ means a conformity assessment body designated in accordance with this Regulation; (43) ‘CE marking of conformity’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing; (44) ‘clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer; (45) ‘clinical investigation’ means any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device; (46) ‘investigational device’ means a device that is assessed in a clinical investigation; (47) ‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation; (48) ‘clinical data’ means information concerning safety or performance that is generated from the use of a device and is sourced from the following: — clinical investigation(s) of the device concerned, — clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated, — reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated, — clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up; (49) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation; (50) ‘subject’ means an individual who participates in a clinical investigation; (51) ‘clinical evidence’ means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer; (52) ‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer; (53) ‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health; (54) ‘investigator’ means an individual responsible for the conduct of a clinical investigation at a clinical investigation site; (55) ‘informed consent’ means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate or, in the case of minors and of incapacitated subjects, an authoris ation or agreement from their legally designated representative to include them in the clinical investigation; (56) ‘ethics committee’ means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations; (57) ‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device; (58) ‘serious adverse event’ means any adverse event that led to any of the following: (a) death, (b) serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect; (59) ‘device deficiency’ means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer; (60) ‘post-market surveillance’ means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions; (61) ‘market surveillance’ means the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection; (62) ‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user; (63) ‘withdrawal’ means any measure aimed at preventing a device in the supply chain from being further made available on the market; (64) ‘incident’ means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect; (65) ‘serious incident’ means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat; (66) ‘serious public health threat’ means an event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time; (67) ‘corrective action’ means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation; (68) ‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market; (69) ‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action; (70) ‘harmonised standard’ means Regulation (EU) No 1025/2012; a European standard as defined in point (1)(c) of Article 2 of (71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system."
},
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": {
"heading": "Amendment of certain definitions",
"text": "The Commission is empowered to adopt delegated acts in accordance with Article 115 in order to amend the definition of nanomaterial set out in point (18) and the related definitions in points (19), (20) and (21) of Article 2 in the light of technical and scientific progress and taking into account definitions agreed at Union and international level."
},
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 34": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": {
"heading": "Regulatory status of products",
"text": "1. Without prejudice to Article 2(2) of Directive 2001/83/EC, upon a duly substantiated request of a Member State, the Commission shall, after consulting the Medical Device Coordination Group established under Article 103 of this Regulation (‘MDCG’), by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory for a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3) of this Regulation. 2. The Commission may also, on its own initiative, after consulting the MDCG, decide, by means of implementing acts, on the issues referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). 3. The Commission shall ensure that Member States share expertise in the fields of medical devices, in vitro diagnostic medical devices, medicinal products, human tissues and cells, cosmetics, biocides, food and, if necessary, other products, in order to determine the appropriate regulatory status of a product, or category or group of products. 4. When deliberating on the possible regulatory status as a device of products involving medicinal products, human tissues and cells, biocides or food products, the Commission shall ensure an appropriate level of consultation of the European Medicines Agency (EMA), the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA), as relevant.—"
},
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Scope and definitions"
}
|
{
"text": "met, together with the grounds, \n— where applicable, an indication that the device contains or incor porate s a medicinal substance, including a human \nblood or plasma derivative, or tissues or cells of human origin, or of animal origin as refer red to in \nRegulation (EU) No 722/2012. \n2. The manuf acturer shall under take to keep available for the compet ent national author ities documentation that \nindicates its manuf actur ing site or sites and allows an understanding to be formed of the design, manufacture and \nperf ormance of the device, including the expected performa nce, so as to allow assessment of conf ormity with the \nrequirements of this Regulation. \n3. The manufacturer shall take all the measures necessar y to ensure that the manufact uring process produces devices \nwhic h are manuf actured in accordance with the documentation refer red to in Section 2. \n4. The statement referred to in the introduct ory part of Section 1 shall be kept for a period of at least 10 years after the \ndevice has been placed on the market. In the case of implantable devices, the period shall be at least 15 years. \nSection 8 of Annex IX shall apply . \n5. The manufacturer shall review and document exper ience gained in the post-production phase, including from PMCF \nas refer red to in Part B of Annex XIV, and implement appropr iate means to apply any necessar y corrective action, In \nthat context, it shall repor t in accordance with Article 87(1) to the compet ent author ities any serious incidents or \nfield safety corrective actions or both as soon as it learns of them. 5.5.2017 L 117/163 Official Jour nal of the European Union EN",
"title": "Annex I and, where applicable, indicating whic h general safety and performance requirements have not been fully"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": null,
"Article 10": {
"heading": "General obligations of manufacturers",
"text": "1. When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation. 2. Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. 3. Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF. 4. Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documen tation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III. The Commission is empowered to adopt delegated acts in accordance with Article 115 amending, in the light of technical progress, the Annexes II and III. 5. Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII. 6. Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19, and affix the CE marking of conformity in accordance with Article 20. 7. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and 31. 8. Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market. Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documen tation in its entirety or a summary thereof. A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11(3), ensure that the authorised representative has the necessary documentation permanently available. 9. Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner. Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device. The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation. The quality management system shall address at least the following aspects: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system; (b) identification of applicable general safety and performance requirements and exploration of options to address those requirements; (c) responsibility of the management; (d) resource management, including selection and control of suppliers and sub-contractors; (e) risk management as set out in in Section 3 of Annex I; (f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF; (g) product realisation, including planning, design, development, production and service provision; (h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29; (i)setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83; (j)handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders; (k) processes for reporting of serious incidents and field safety corrective actions in the context of vigilance; (l) management of corrective and preventive actions and verification of their effectiveness; (m) processes for monitoring and measurement of output, data analysis and product improvement. 10. Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article 83. 11. Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient. 12. Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Regulation shall immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate. They shall inform the distributors of the device in question and, where applicable, the authorised representative and importers accordingly. Where the device presents a serious risk, manufacturers shall immediately inform the competent authorities of the Member States in which they made the device available and, where applicable, the notified body that issued a certificate for the device in accordance with Article 56, in particular, of the non-compliance and of any corrective action taken. 13. Manufacturers shall have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88. 14. Manufacturers shall, upon request by a competent authority, provide it with all the information and documen tation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned. The competent authority of the Member State in which the manufacturer has its registered place of business may require that the manufacturer provide samples of the device free of charge or, where that is impracticable, grant access to the device. Manufacturers shall cooperate with a competent authority, at its request, on any corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market or put into service. If the manufacturer fails to cooperate or the information and documentation provided is incomplete or incorrect, the competent authority may, in order to ensure the protection of public health and patient safety, take all appropriate measures to prohibit or restrict the device's being made available on its national market, to withdraw the device from that market or to recall it until the manufacturer cooperates or provides complete and correct information. If a competent authority considers or has reason to believe that a device has caused damage, it shall, upon request, facilitate the provision of the information and documentation referred to in the first subparagraph to the potentially injured patient or user and, as appropriate, the patient's or user's successor in title, the patient's or user's health insurance company or other third parties affected by the damage caused to the patient or user, without prejudice to data protection rules and, unless there is an overriding public interest in disclosure, without prejudice to the protection of intellectual property rights. The competent authority need not comply with the obligation laid down in the third subparagraph where disclosure of the information and documentation referred to in the first subparagraph is ordinarily dealt with in the context of legal proceedings. 15. Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 30(1). 16. Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law."
},
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": {
"heading": "Authorised representative",
"text": "1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. 2. The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group. 3. The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request. The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers: (a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer; (b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8); (c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29; (d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned; (e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised rep resentative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device; (f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices; (g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated; (h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation. 4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12). 5. Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer. 6. An authorised representative who terminates its mandate on the ground referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor. 7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business."
},
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": {
"heading": "Change of authorised representative",
"text": "The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. That agreement shall address at least the following aspects: (a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative; (b) the date until which the outgoing authorised representative may be indicated in the information supplied by the manufacturer, including any promotional material; (c) the transfer of documents, including confidentiality aspects and property rights; (d) the obligation of the outgoing authorised representative after the end of the mandate to forward to the manufacturer or incoming authorised representative any complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device for which it had been designated as authorised rep resentative."
},
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": {
"heading": "General obligations of importers",
"text": "1.Importers shall place on the Union market only devices that are in conformity with this Regulation. 2.In order to place a device on the market, importers shall verify that: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up; (b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer; (c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use; (d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27. Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer's authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established. 3. Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer. 4. Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31. 5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available. 6. Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints. 7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer's authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken. 8. Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative. 9. Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56. 10. Importers shall cooperate with competent authorities, at the latters' request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device."
},
"Article 14": {
"heading": "General obligations of distributors",
"text": "1. When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable. 2. Before making a device available on the market, distributors shall verify that all of the following requirements are met: (a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up; (b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11); (c) for imported devices, the importer has complied with the requirements set out in Article 13(3); (d) that, where applicable, a UDI has been assigned by the manufacturer. In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph the distributor may apply a sampling method that is representative of the devices supplied by that distributor.Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established. 3. Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer. 4. Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufac turer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer, and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the Member States in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. 5. Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request. 6. Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device. Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device."
},
"Article 15": {
"heading": "1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing. 2. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (1) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal. 3. EN Official Journal of the European Union L 117/29 The person responsible for regulatory compliance shall at least be responsible for ensuring that: (a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued. 4. If a number of persons are jointly responsible for regulatory compliance in accordance with paragraphs 1, 2 and 3, their respective areas of responsibility shall be stipulated in writing. 5. The person responsible for regulatory compliance shall suffer no disadvantage within the manufacturer's organisation in relation to the proper fulfilment of his or her duties, regardless of whether or not they are employees of the organisation. 6. Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union. The requisite expertise shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; (b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.",
"text": "Article 15 Article 20 Article 109 \nArticle 15a Article 20a Article 102"
},
"Article 16": {
"heading": "Cases in which obligations of manufacturers apply to importers, distributors or other persons",
"text": "1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following: (a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation; (b) changes the intended purpose of a device already placed on the market or put into service; (c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected. The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose. 2. For the purposes of point (c) of paragraph 1, the following shall not be considered to be a modification of a device that could affect its compliance with the applicable requirements: (a) provision, including translation, of the information supplied by the manufacturer, in accordance with Section 23 of Annex I, relating to a device already placed on the market and of further information which is necessary in order to market the device in the relevant Member State; (b) changes to the outer packaging of a device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. In the case of devices placed on the market in sterile condition, it shall be presumed that the original condition of the device is adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging. 3. A distributor or importer that carries out any of the activities mentioned in points (a) and (b) of paragraph 2 shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its name, registered trade name or registered trade mark, registered place of business and the address at which it can be contacted, so that its location can be established. Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the activities mentioned in points (a) and (b) of paragraph 2 are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover, inter alia, procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation. 4. At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in points (a) and (b) of paragraph 2, attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3."
},
"Article 17": {
"heading": "Single-use devices and their reprocessing",
"text": "1. Reprocessing and further use of single-use devices may only take place where permitted by national law and only in accordance with this Article. 2. Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC. 3. By way of derogation from paragraph 2, as regards single-use devices that are reprocessed and used within a health institution, Member States may decide not to apply all of the rules relating to manufacturers' obligations laid down in this Regulation provided that they ensure that: (a) the safety and performance of the reprocessed device is equivalent to that of the original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of Article 5(5) are complied with; (b) the reprocessing is performed in accordance with CS detailing the requirements concerning: — risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing, — the validation of procedures for the entire process, including cleaning steps, — the product release and performance testing, — the quality management system, — the reporting of incidents involving devices that have been reprocessed, and — the traceability of reprocessed devices. Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information on the reprocessed devices that patients are treated with. Member States shall notify the Commission and the other Member States of the national provisions introduced pursuant to this paragraph and the grounds for introducing them. The Commission shall keep the information publicly available. 4. Member States may choose to apply the provisions referred to in paragraph 3 also as regards single-use devices that are reprocessed by an external reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is returned to that health institution and the external reprocessor complies with the requirements referred to in points (a) and (b) of paragraph 3. 5. The Commission shall adopt, in accordance with Article 9(1), the necessary CS referred to in point (b) of paragraph 3 by 26 May 2020. Those CS shall be consistent with the latest scientific evidence and shall address the application of the general requirements on safety and performance laid down in in this Regulation. In the event that those CS are not adopted by 26 May 2020, reprocessing shall be performed in accordance with any relevant harmonised standards and national provisions that cover the aspects outlined in point (b) of paragraph 3. Compliance with CS or, in the absence of CS, with any relevant harmonised standards and national provisions, shall be certified by a notified body. 6. Only single-use devices that have been placed on the market in accordance with this Regulation, or prior to 26 May 2020 in accordance with Directive 93/42/EEC, may be reprocessed. 7. Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out. 8. The name and address of the legal or natural person referred to in paragraph 2 and the other relevant information referred to in Section 23 of Annex I shall be indicated on the label and, where applicable, in the instructions for use of the reprocessed device. The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device. 9. A Member State that permits reprocessing of single-use devices may maintain or introduce national provisions that are stricter than those laid down in this Regulation and which restrict or prohibit, within its territory, the following: (a) the reprocessing of single-use devices and the transfer of single-use devices to another Member State or to a third country with a view to their reprocessing; (b) the making available or further use of reprocessed single-use devices. Member States shall notify the Commission and the other Member States of those national provisions. The Commission shall make such information publicly available. 10. The Commission shall by 27 May 2024 draw up a report on the operation of this Article and submit it to the European Parliament and to the Council. On the basis of that report, the Commission shall, if appropriate, make proposals for amendments to this Regulation."
},
"Article 18": {
"heading": "Implant card and information to be supplied to the patient with an implanted device",
"text": "Implant card and information to be supplied to the patient with an implanted device \n1. The manufacturer of an imp lantable device shall provide together with the device the following: \n(a) information allowing the identification of the device, including the device name, serial number , lot number , the UDI, \nthe device model, as well as the name, address and the website of the manufacturer; \n(b) any warnings, precautions or measures to be take n by the patient or a healthcare professional with regard to \nreciprocal interference with reasonably foreseeable exte rnal influences, medical examinations or environmental \nconditions; \n(c) any information about the expect ed lifetime of the device and any necessar y follow-up; \n(d) any other information to ensure safe use of the device by the patient, including the information in point (u) of \nSection 23.4 of Annex I. 5.5.2017 L 117/31 Official Jour nal of the European Union EN \n The information referred to in the first subparagraph shall be provided, for the purpose of making it available to the \nparticular patient who has been implant ed with the device, by any means that allow rapid access to that information \nand shall be stated in the languag e(s) determined by the concer ned Member State . The information shall be written in \na way that is readily underst ood by a lay person and shall be updated where appropr iate. Update s of the information \nshall be made available to the patient via the website mentioned in point (a) of the first subparagraph. \nIn addition, the manuf acturer shall provide the information refer red to in point (a) of the first subparagraph on an \nimplant card delivered with the device. \n2. Member States shall require health institutions to make the information refer red to in paragraph 1 available, by \nany means that allow rapid access to that information, to any patients who have been implanted with the device, \ntogether with the implant card, whic h shall bear their identity . \n3. The following implants shall be exem pted from the oblig ations laid down in this Article: sutures, staples, dental \nfillings, dental braces, tooth crowns, screws, wedges, plates , wires, pins, clips and connectors. The Commission is \nempo wered to adopt delegat ed acts in accordance with Article 115 to amend this list by adding other types of implants \nto it or by remo ving implants therefrom."
},
"Article 19": {
"heading": "EU declaration of conformity",
"text": "The EU declaration of confo rmity \n1. The EU declaration of conf ormity shall state that the requirements specif ied in this Regulation have been fulfilled \nin relation to the device that is covered. The manufa cturer shall continuously updat e the EU declaration of conf ormity . \nThe EU declaration of conf ormity shall, as a minimum, contain the information set out in Annex IV and shall be \ntranslate d into an official Union language or languag es required by the Member State (s) in whic h the device is made \navailable. \n2. Where, concer ning aspects not covered by this Regulation, devices are subject to other Union legislation which \nalso requires an EU declaration of conf ormity by the manuf acturer that fulfilment of the requirements of that legislation \nhas been demonstrated , a sing le EU declaration of conf ormity shall be drawn up in respect of all Union acts applicable \nto the device. The declaration shall contain all the information required for identification of the Union legislation to \nwhic h the declaration relat es. \n3. By drawing up the EU declaration of conf ormity , the manufacturer shall assume responsibility for compliance with \nthe requirements of this Regulation and all other Union legislation applicable to the device. \n4. The Commission is empo wered to adopt delegat ed acts in accordance with Article 115 amending the minimum \nconte nt of the EU declaration of conf ormity set out in Annex IV in the light of technical progress."
},
"Article 2": null,
"Article 20": {
"heading": "CE marking of conformity",
"text": "Article 20 \nCE marking of conformity \n1. Devices, other than custom-made or inve stigational devices, considered to be in conf ormity with the requirements \nof this Regulation shall bear the CE marking of conf ormity , as present ed in Annex V. \n2. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. \n3. The CE marking shall be affixed visibly , legibly and indelibly to the device or its sterile packag ing. Where such \naffixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to the \npackag ing. The CE marking shall also appear in any instr uctions for use and on any sales packaging. \n4. The CE marking shall be affixed before the device is placed on the mark et. It may be followed by a pictogram or \nany other mark indicating a special risk or use. \n5. Where applicable, the CE marking shall be followed by the identif ication number of the notified body responsible \nfor the conf ormity assessment procedures set out in Article 52. The identification number shall also be indicate d in any \npromotional mater ial which mentions that a device fulfils the requirements for CE marking. \n6. Where devices are subject to other Union legislation whic h also provides for the affixing of the CE marking, the \nCE marking shall indicate that the devices also fulfil the requirements of that other legislation."
},
"Article 21": {
"heading": "Devices for special purposes",
"text": "Article 21 \nDevices for special pur poses \n1. Member States shall not creat e obstacles to: \n(a) inve stigational devices being supplied to an inve stigat or for the purpose of a clinical investig ation if they meet the \nconditions laid down in Articles 62 to 80 and Article 82, in the implementing acts adop ted pursuant to Article 81 \nand in Annex XV; \n(b) custom-mad e devices being made available on the mark et if Article 52(8) and Annex XIII have been compl ied with. \nThe devices refer red to in the first subparagraph shall not bear the CE marking, with the exce ption of the devices \nreferred to in Article 74. \n2. Cust om-made devices shall be accompan ied by the state ment referred to in Section 1 of Annex XIII, whic h shall be \nmade available to the particular patient or user identif ied by name, an acron ym or a numer ical code. \nMember States may require that the manuf acturer of a custom-made device submit to the compet ent author ity a list of \nsuch devices which have been made available in their territory . \n3. At trade fairs, exhibitions, demonstrations or similar events, Member States shall not creat e obstacles to the \nshowing of devices which do not compl y with this Regulation, provided a visible sign clearly indicates that such devices \nare intended for presentation or demonstration purposes only and cannot be made available until they have been \nbrought into compl iance with this Regulation."
},
"Article 22": {
"heading": "Systems and procedure packs",
"text": "Article 22 \nSystems and procedure packs \n1. Natural or legal persons shall draw up a statement if they combine devices bear ing a CE marking with the \nfollowing other devices or products, in a manner that is compati ble with the intended purpose of the devices or other \nproducts and within the limits of use specifi ed by their manuf acturers, in order to place them on the mark et as a system \nor procedure pack: \n(a) other devices bear ing the CE marking; \n(b) in vitro diagnostic medical devices bear ing the CE marking in conf ormity with Regulation (EU) 2017/746; \n(c) other products whic h are in conf ormity with legislation that applies to those products only where they are used \nwithin a medical procedure or their presence in the syste m or procedure pack is other wise justif ied. \n2. In the statement made pursuant to paragraph 1, the natural or legal person concer ned shall declare that: \n(a) they verified the mutual compati bility of the devices and, if applicable other products, in accordance with the manu \nfacturers' instr uctions and have carried out their activities in accordance with those instr uctions; \n(b) they packag ed the system or procedure pack and supplied relevant information to users incor porating the \ninformation to be supplied by the manuf acturers of the devices or other products whic h have been put together; \n(c) the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to \nappropr iate methods of internal monitori ng, verification and validation. \n3. Any natural or legal person who steri lises systems or procedure packs refer red to in paragraph 1 for the purpose \nof placing them on the market shall, at their choice, apply one of the procedures set out in Annex IX or the procedure \nset out in Part A of Annex XI. The application of those procedures and the involvement of the notified body shall be \nlimited to the aspects of the procedure relating to ensur ing sterilit y until the sterile packa ging is opened or damage d. \nThe natural or legal person shall draw up a state ment declar ing that sterilisation has been carried out in accordance with \nthe manufact urer's instr uctions. \n4. Where the system or procedure pack incor porate s devices which do not bear the CE marking or where the chosen \ncombination of devices is not compati ble in view of their original intended purpose, or where the sterilisation has not \nbeen carried out in accordance with the manufacturer's instr uctions, the system or procedure pack shall be treated as \na device in its own right and shall be subject to the relevant conf ormity assessment procedure pursuant to Article 52. \nThe natural or legal person shall assume the oblig ations incumbent on manuf acturers. 5.5.2017 L 117/33 Official Jour nal of the European Union EN \n 5. The system s or procedure packs referred to in paragraph 1 of this Article shall not themselves bear an additional \nCE marking but they shall bear the name, registered trade name or registere d trade mark of the person refer red to in \nparagraphs 1 and 3 of this Article as well as the address at whic h that person can be contact ed, so that the person's \nlocation can be established. Systems or procedure packs shall be accompanied by the information referred to in \nSection 23 of Annex I. The statement refer red to in paragraph 2 of this Article shall be kept at the disposal of the \ncompet ent author ities, after the system or procedure pack has been put together , for the period that is applicable under Article 10(8) to the devices that have been combined. Where those periods differ, the longest period shall apply."
},
"Article 23": {
"heading": "Parts and components",
"text": "1. Any natural or lega l person who mak es available on the mark et an item specifically intende d to replace an \nidentical or similar integral part or compo nent of a device that is defective or worn in order to maintain or restore the \nfunction of the device without changing its performa nce or safety charact eristics or its intended purpose, shall ensure \nthat the item does not adversely affect the safety and performa nce of the device. Suppor ting evidence shall be kept \navailable for the compet ent author ities of the Member State s. \n2. An item that is intended specifi cally to replace a part or component of a device and that signif icantly chang es the \nperforma nce or safety charact eristics or the intended purpose of the device shall be considered to be a device and shall \nmeet the requirements laid down in this Regulation."
},
"Article 24": {
"heading": "Free movement",
"text": "Article 24 \nFree movement \nExcept where other wise provided for in this Regulation, Member States shall not refuse, prohibit or restrict the making \navailable on the market or putting into service within their territory of devices whic h compl y with the requirements of \nthis Regulation."
},
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 34": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": {
"heading": "Placing on the market and putting into service",
"text": "1. A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose. 2. A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose. 3. Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61. 4. Devices that are manufactured and used within health institutions shall be considered as having been put into service. 5. With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met: (a) the devices are not transferred to another legal entity, (b) manufacture and use of the devices occur under appropriate quality management systems, (c) the health institution justifies in its documentation that the target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market, (d) the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use; (e) the health institution draws up a declaration which it shall make publicly available, including: (i) the name and address of the manufacturing health institution; (ii) the details necessary to identify the devices; (iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor, (f) the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met; (g) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (f), and (h) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions. Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory. Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions. This paragraph shall not apply to devices that are manufactured on an industrial scale. 6. In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3)."
},
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": {
"heading": "Distance sales",
"text": "1. A device offered by means of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to a natural or legal person established in the Union shall comply with this Regulation. 2. Without prejudice to national law regarding the exercise of the medical profession, a device that is not placed on the market but used in the context of a commercial activity, whether in return for payment or free of charge, for the provision of a diagnostic or therapeutic service offered by means of information society services as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535 or by other means of communication, directly or through intermediaries, to a natural or legal person established in the Union shall comply with this Regulation. 3. Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned. 4. A Member State may, on grounds of protection of public health, require a provider of information society services, as defined in point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its activity."
},
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": {
"heading": "Claims",
"text": "In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: (a) ascribing functions and properties to the device which the device does not have; (b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; (c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; (d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out."
},
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": {
"heading": "Use of harmonised standards",
"text": "1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’). References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union. 2. References in this Regulation to harmonised standards shall also include the monographs of the European Pharma copoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union."
},
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": {
"heading": "Common specifications",
"text": "1. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those provisions, where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to address public health concerns, the Commission, after having consulted the MDCG, may, by means of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in Annex XIV or the requirements regarding clinical investigation set out in Annex XV. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3). 2. Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS. 3. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto. 4. Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products."
},
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "MAKING AVAILABLE ON THE MARKET AND PUTTING INTO SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT"
}
|
{
"text": "TECHNIC AL DOCUMENT ATION \nThe technical documentation and, if applicable, the summar y thereof to be drawn up by the manuf acturer shall be \npresent ed in a clear , organised, readily searc hable and unambiguous manner and shall include in particular the elements \nlisted in this Annex. \n1. DEVICE DESCRIPTION AND SPECIFIC ATION, INCLUDING VARIANTS AND ACCESSORIES \n1.1. Device descr iption and specification \n(a) product or trade name and a general descr iption of the device including its intended purpose and intended \nusers; \n(b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, \nas soon as identif ication of this device becomes based on a UDI system, or other wise a clear identification by \nmeans of product code, catalogue number or other unambiguous reference allowing traceability ; \n(c) the intended patient population and medical conditions to be diagnosed, treated and/or monit ored and other \nconsiderations such as patient selection criteria, indications, contra-indications, warnings; \n(d) principles of operation of the device and its mode of action, scientifi cally demonstrated if necessar y; \n(e) the rationale for the qualifi cation of the product as a device; \n(f) the risk class of the device and the justif ication for the classificat ion rule(s) applied in accordance with",
"title": "ANNEX II"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": {
"heading": "Identification within the supply chain",
"text": "1. Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices. 2. Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8): (a) any economic operator to whom they have directly supplied a device; (b) any economic operator who has directly supplied them with a device; (c) any health institution or healthcare professional to which they have directly supplied a device."
},
"Article 26": {
"heading": "Medical devices nomenclature",
"text": "To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, the \nCommission shall ensure that an intern ationally recognised medical devices nomenclature is available free of charge to \nmanufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission \nshall also endeavour to ensure that that nomenclature is available to other stake holders free of charge, where reasonably \npracticable."
},
"Article 27": {
"heading": "Unique Device Identification [UDI] system",
"text": "1. The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identifi cation and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following: (a) production of a UDI that comprises the following: (i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI; (ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI; (b) placing of the UDI on the label of the device or on its packaging; (c) storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively; (d) establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28. 2. The Commission shall, by means of implementing acts, designate one or several entities to operate a system for assignment of UDIs pursuant to this Regulation (‘issuing entity’). That entity or those entities shall satisfy all of the following criteria: (a) the entity is an organisation with legal personality; (b) its system for the assignment of UDIs is adequate to identify a device throughout its distribution and use in accordance with the requirements of this Regulation; (c) its system for the assignment of UDIs conforms to the relevant international standards; (d) the entity gives access to its system for the assignment of UDIs to all interested users in accordance with a set of predetermined and transparent terms and conditions; (e) the entity undertakes to do the following: (i) operate its system for the assignment of UDIs for at least 10 years after its designation; (ii) make available to the Commission and to the Member States, upon request, information concerning its system for the assignment of UDIs; (iii) remain in compliance with the criteria for designation and the terms of designation. When designating issuing entities, the Commission shall endeavour to ensure that UDI carriers, as defined in Part C of Annex VI, are universally readable regardless of the system used by the issuing entity, with a view to minimising financial and administrative burdens for economic operators and health institutions. 3. Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2. Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28. 4. UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers. 5. The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87. 6. The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appear on the EU declaration of conformity referred to in Article 19. 7. As part of the technical documentation referred to in Annex II, the manufacturer shall keep up-to-date a list of all UDIs that it has assigned. 8. Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to: — class III implantable devices; — the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11. 9. Health institutions shall store and keep preferably by electronic means the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to class III implantable devices. For devices other than class III implantable devices, Member States shall encourage, and may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied. Member States shall encourage, and may require, healthcare professionals to store and keep preferably by electronic means, the UDI of the devices with which they have been supplied with. 10. The Commission is empowered to adopt delegated acts in accordance with Article 115: (a) amending the list of information set out in Part B of Annex VI in the light of technical progress; and (b) amending Annex VI in the light of international developments and technical progress in the field of Unique Device Identification. 11. The Commission may, by means of implementing acts, specify the detailed arrangements and the procedural aspects for the UDI system with a view to ensuring its harmonised application in relation to any of the following: (a) determining the devices, categories or groups of devices to which the obligation laid down in paragraph 8 is to apply; (b) specifying the data to be included in the UDI-PI of specific devices or device groups; The implementing acts referred to in the first subparagraph shall be adopted in accordance with the examination procedure referred to in Article 114(3). 12. When adopting the measures referred to in paragraph 11, the Commission shall take into account all of the following: (a) confidentiality and data protection as referred to in Articles 109 and 110 respectively; (b) the risk-based approach; (c) the cost-effectiveness of the measures; (d) the convergence of UDI systems developed at international level; (e) the need to avoid duplications in the UDI system; (f) the needs of the healthcare systems of the Member States, and where possible, compatibility with other medical device identification systems that are used by stakeholders."
},
"Article 28": {
"heading": "UDI database",
"text": "1. The Commission, after consulting the MDCG shall set up and manag e a UDI database to validate, collate, process \nand mak e available to the public the information mentioned in Part B of Annex VI. \n2. When designing the UDI database, the Commission shall take into account the general principles set out in \nSection 5 of Part C of Annex VI. The UDI database shall be designed in particular such that no UDI-PIs and no \ncommercially conf idential product information can be included therein. \n3. The core data elements to be provided to the UDI database, refer red to in Part B of Annex VI, shall be accessible to \nthe public free of charge. \n4. The technical design of the UDI database shall ensure maximum accessibility to information stored therein, \nincluding multi-user access and automatic uploads and downloads of that information. The Commission shall provide \nfor technical and administrative suppor t to manufacturers and other users of the UDI database."
},
"Article 29": {
"heading": "Registration of devices",
"text": "1. Before placing a device, other than a custom-ma de device, on the market, the manufa cturer shall, in accordance \nwith the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to \nthe device and shall provide it to the UDI database together with the other core data elements refer red to in Part B of \nAnnex VI related to that device. \n2. Before placing on the mark et a system or procedure pack pursuant to Article 22(1) and (3), that is not a custom- \nmade device, the natural or legal person responsible shall assign to the system or procedure pack, in compliance with \nthe rules of the issuing entity , a Basic UDI-DI and shall provide it to the UDI database together with the other core data \nelements refer red to in Part B of Annex VI relat ed to that syste m or procedure pack. \n3. For devices that are the subject of a conf ormity assessment as refer red to in Article 52(3) and in the second and \nthird subparagraphs of Article 52(4), the assignment of a Basic UDI-DI refer red to in paragraph 1 of this Article shall be \ndone before the manufacturer applies to a notified body for that assessment. \nFor the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on \nthe certificate issued in accordance with point (a) of Section 4 of Chapt er I of Annex XII and conf irm in Eudamed that \nthe information refer red to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate \nand before placing the device on the market, the manuf acturer shall provide the Basic UDI-DI to the UDI database \ntogether with the other core data elements referred to in Part B of Annex VI relat ed to that device. \n4. Before placing a device on the market, other than a custom-mad e device, the manufa cturer shall enter or if, already \nprovided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the excep tion of \nSection 2.2 thereof, and shall thereaf ter keep the information updated."
},
"Article 3": null,
"Article 30": {
"heading": "Electronic system for registration of economic operators",
"text": "1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to creat e the sing le \nregistration number referred to in Article 31(2) and to collat e and process information that is necessar y and propor \ntionate to identify the manufacturer and, where applicable, the author ised representative and the importer. The details \nregar ding the information to be provided to that electronic syste m by the economic operat ors are laid down in Section 1 \nof Part A of Annex VI. \n2. Member States may maintain or introduce national provisions on registration of distr ibutors of devices whic h have \nbeen made available on their territory. \n3. Within two weeks of placing a device, other than a custom-made device, on the mark et, impor ters shall verify that \nthe manufacturer or author ised representative has provided to the electronic system the information referred to in \nparagraph 1. \nWhere applicable, impor ters shall inform the relevant author ised representative or manufacturer if the information \nreferred to in paragraph 1 is not included or is incor rect. Impor ters shall add their details to the relevant entry/entries."
},
"Article 31": {
"heading": "Registration of manufacturers, authorised representatives and importers",
"text": "1. Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that they have not already registered in accordance with this Article. In cases where the conformity assessment procedure requires the involvement of a notified body pursuant to Article 52, the information referred to in Section 1 of Part A of Annex VI shall be provided to that electronic system before applying to the notified body. 2. After having verified the data entered pursuant to paragraph 1, the competent authority shall obtain a single registration number (‘SRN’) from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer. 3. The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29. 4. Within one week of any change occurring in relation to the information referred to in paragraph 1 of this Article, the economic operator shall update the data in the electronic system referred to in Article 30. 5. Not later than one year after submission of the information in accordance with paragraph 1, and every second year thereafter, the economic operator shall confirm the accuracy of the data. In the event of a failure to do so within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until that economic operator complies with that obligation. 6. Without prejudice to the economic operator's responsibility for the data, the competent authority shall verify the confirmed data referred to in Section 1 of Part A of Annex VI. 7. The data entered pursuant to paragraph 1 of this Article in the electronic system referred to in Article 30 shall be accessible to the public. 8. The competent authority may use the data to charge the manufacturer, the authorised representative or the importer a fee pursuant to Article 111."
},
"Article 32": {
"heading": "Summary of safety and clinical performance",
"text": "1. For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of the summary of safety and clinical performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 52 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available. 2. The summary of safety and clinical performance shall include at least the following aspects: (a) the identification of the device and the manufacturer, including the Basic UDI-DI and, if already issued, the SRN; (b) the intended purpose of the device and any indications, contraindications and target populations; (c) a description of the device, including a reference to previous generation(s) or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with the device; (d) possible diagnostic or therapeutic alternatives; (e) reference to any harmonised standards and CS applied; (f) the summary of clinical evaluation as referred to in Annex XIV, and relevant information on post-market clinical follow-up; (g) suggested profile and training for users; (h) information on any residual risks and any undesirable effects, warnings and precautions. 3. The Commission may, by means of implementing acts, set out the form and the presentation of the data elements to be included in the summary of safety and clinical performance. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 114(2)."
},
"Article 33": {
"heading": "European database on medical devices",
"text": "European database on medical devices \n1. The Commission, after consulting the MDCG, shall set up, maintain and manage the European database on \nmedical devices (‘Eudamed’) for the following purposes: \n(a) to enable the public to be adequat ely informed about devices placed on the mark et, the corresponding certificates \nissued by notified bodies and about the relevant economic operators; 5.5.2017 L 117/38 Official Jour nal of the European Union EN \n (b) to enable unique identification of devices within the internal market and to facilitate their traceability ; \n(c) to enable the public to be adequately informed about clinical investigat ions and to enable sponsors of clinical inve sti\ngations to compl y with obligations under Articles 62 to 80, Article 82, and any acts adopt ed pursuant to Article 81; \n(d) to enable manuf acturers to compl y with the information oblig ations laid down in Articles 87 to 90 or in any acts \nadopt ed pursuant to Article 91; \n(e) to enable the compet ent author ities of the Member State s and the Commission to carry out their tasks relating to \nthis Regulation on a well-inf ormed basis and to enhance the cooperation between them. \n2. Eudamed shall include the following electronic systems: \n(a) the electronic system for registration of devices refer red to in Article 29(4); \n(b) the UDI-database referred to in Article 28; \n(c) the electronic system on registration of economic operat ors referred to in Article 30; \n(d) the electronic system on notified bodies and on certificates refer red to in Article 57; \n(e) the electronic system on clinical investig ations referred to in Article 73; \n(f) the electronic system on vigilance and post-market surveillance refer red to in Article 92; \n(g) the electronic system on mark et surveillance refer red to in Article 100. \n3. When designing Eudamed the Commission shall give due consideration to compati bility with national databases \nand national web-int erfaces to allow for import and expor t of data. \n4. The data shall be entered into Eudamed by the Member State s, notified bodies, economic operat ors and sponsors \nas specifi ed in the provisions on the electronic systems refer red to in paragraph 2. The Commission shall provide for \ntechnical and administrative suppor t to users of Eudamed. \n5. All the information collated and processed by Eudamed shall be accessible to the Member State s and to the \nCommission. The information shall be accessible to notifi ed bodies, economic operators, sponsors and the public to the \nextent specified in the provisions on the electronic systems refer red to in paragraph 2. \nThe Commission shall ensure that public parts of Eudamed are presented in a user -friendly and easily-searchab le format. \n6. Eudamed shall contain personal data only insof ar as necessar y for the electronic syste ms referred to in paragraph 2 \nof this Article to collate and process information in accordance with this Regulation. Personal data shall be kept in \na form which permits identif ication of data subjects for periods no long er than those refer red to in Article 10(8). \n7. The Commission and the Member State s shall ensure that data subjects may effectively exer cise their rights to \ninformation, of access, to rectificatio n and to object in accordance with Regulation (EC) No 45/2001 and \nDirective 95/46/EC, respectively . They shall also ensure that data subjects may effectively exercise the right of access to \ndata relating to them, and the right to have inaccurat e or incomplet e data corrected and erased. Within their respective \nresponsibilities, the Commission and the Member States shall ensure that inaccurate and unlawfully processed data are \ndelet ed, in accordance with the applicable legislation. Corrections and deletions shall be carried out as soon as possible, \nbut no later than 60 days after a request is made by a data subject. \n8. The Commission shall, by means of imp lementing acts, lay down the detailed arrang ements necessar y for the \nsetting up and maint enance of Eudamed. Those implementing acts shall be adopt ed in accordance with the examination \nprocedure refer red to in Article 114(3). When adop ting those implementing acts, the Commission shall ensure that, as \nfar as possible, the system is developed in such a way as to avoid having to enter the same information twice within the \nsame module or in diffe rent modules of the system . \n9. In relation to its responsibilities under this Article and the processing of personal data involved therein, the \nCommission shall be considered to be the controller of Eudamed and its electronic systems."
},
"Article 34": {
"heading": "Functionality of Eudamed",
"text": "1. The Commission shall, in collaboration with the MDCG, draw up the functional specifications for Eudamed. The Commission shall draw up a plan for the implementation of those specifications by 26 May 2018. That plan shall seek to ensure that Eudamed is fully functional at a date that allows the Commission to publish the notice referred to in paragraph 3 of this Article by 25 March 2020 and that all other relevant deadlines laid down in Article 123 of this Regulation and in Article 113 of Regulation (EU) 2017/746 are met. 2. The Commission shall, on the basis of an independent audit report, inform the MDCG when it has verified that Eudamed has achieved full functionality and Eudamed meets the functional specifications drawn up pursuant to paragraph 1. 3. The Commission shall, after consultation with the MDCG and when it is satisfied that the conditions referred to in paragraph 2 have been fulfilled, publish a notice to that effect in the Official Journal of the European Union."
},
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES"
}
|
{
"text": "TEC HNIC AL DOCUMENT ATION ON POST -MARKET SUR VEILL ANCE \nThe technical documentation on post-market surveillance to be drawn up by the manuf acturer in accordance with \nArticles 83 to 86 shall be present ed in a clear , organised, readily searc hable and unambiguous manner and shall include \nin particular the elements descr ibed in this Annex. \n1.1. The post-market surveillance plan drawn up in accordance with Article 84. \nThe manufacturer shall prove in a post-market surveillance plan that it compl ies with the obligation referred to \nin Article 83. \n(a) The post-market surveillance plan shall address the collection and utilization of available information, in \nparticular: \n— information concer ning serious incidents, including information from PSURs, and field safety corrective \nactions; \n— records refer ring to non-ser ious incidents and data on any undesirable side-eff ects; \n— information from trend repor ting; \n— relevant specialist or technical literature, databases and/or register s; \n— information, including feedbacks and complaints, provided by users, distr ibut ors and impor ters; and \n— publicly available information about similar medical devices. \n(b) The post-market surveillance plan shall cover at least : \n— a proactive and syste matic process to collect any information refer red to in point (a). The process shall \nallow a correct charact erisation of the perf ormance of the devices and shall also allow a compari son to \nbe made between the device and similar products available on the market ; \n— effective and appropr iate methods and processes to assess the collected data; \n— suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- \nrisk analysis and of the risk managemen t as referred to in Section 3 of Annex I; \n— effective and appropr iate methods and tools to investig ate compl aints and analyse mark et-related \nexper ience collect ed in the field; \n— methods and protocols to manage the events subject to the trend repor t as provided for in Article 88, \nincluding the methods and prot ocols to be used to establish any statistically signif icant increase in the \nfrequency or sever ity of incidents as well as the obser vation period; \n— methods and protocols to communicate effectively with compet ent author ities, notifi ed bodies, economic \noperat ors and users; \n— reference to procedures to fulfil the manuf acturers oblig ations laid down in Articles 83, 84 and 86; \n— system atic procedures to identify and initiate appropr iate measures including corrective actions; \n— effective tools to trace and identify devices for which corrective actions might be necessar y; and \n— a PMCF plan as refer red to in Part B of Annex XIV, or a justif ication as to why a PMCF is not applicable. \n1.2. The PSUR refer red to in Article 86 and the post-market surveillance repor t refer red to in Article 85. 5.5.2017 L 117/112 Official Jour nal of the European Union EN",
"title": "ANNEX III"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 34": null,
"Article 35": {
"heading": "Authorities responsible for notified bodies",
"text": "1. Any Member State that intends to designat e a conf ormity assessment body as a notifi ed body , or has designat ed \na notified body , to carry out conf ormity assessment activities under this Regulation shall appoint an author ity (‘author ity \nresponsible for notified bodies’), which may consist of separate constituent entities under national law and shall be \nresponsible for setting up and carrying out the necessar y procedures for the assessment, designation and notificati on of \nconf ormity assessment bodies and for the monitori ng of notifi ed bodies, including subcontractors and subsidiar ies of \nthose bodies. \n2. The author ity responsible for notified bodies shall be established, organised and operat ed so as to safeg uard the \nobjectivity and impartiality of its activities and to avoid any conf licts of interests with conf ormity assessment bodies. \n3. The author ity responsible for notified bodies shall be organised in a manner such that each decision relating to \ndesignation or notificati on is taken by personnel diffe rent from those who carried out the assessment. \n4. The author ity responsible for notified bodies shall not perform any activities that notified bodies perform on \na commercial or compe titive basis. \n5. The author ity responsible for notified bodies shall safeg uard the confidential aspects of the information it obtains. \nHowever , it shall exchang e information on notifi ed bodies with other Member State s, the Commission and, when \nrequired, with other regulatory author ities. \n6. The author ity responsible for notified bodies shall have a sufficient number of compet ent personnel permanently \navailable for the proper performa nce of its tasks. \nWhere the author ity responsible for notifi ed bodies is a diffe rent author ity from the national compet ent author ity for \nmedical devices, it shall ensure that the national authority responsible for medical devices is consulted on relevant \nmatters. \n7. Member State s shall make publicly available general information on their measures governing the assessment, \ndesignation and notification of conformity assessment bodies and for the monitoring of notifi ed bodies, and on chang es \nwhic h have a significant impact on such tasks. \n8. The authority responsible for notified bodies shall participate in the peer -review activities provided for in Article 48"
},
"Article 36": {
"heading": "Requirements relating to notified bodies",
"text": "1. Notified bodies shall fulfil the tasks for which they are designat ed in accordance with this Regulation. They shall \nsatisfy the organisational and general requirements and the quality management, resource and process requirements that \nare necessar y to fulfil those tasks. In particular , notifi ed bodies shall compl y with Annex VII. \nIn order to meet the requirements refer red to in the first subparagraph, notifi ed bodies shall have permanent availability \nof suffi cient administrative, technical and scientific personnel in accordance with Section 3.1.1 of Annex VII and \npersonnel with relevant clinical exper tise in accordance with Section 3.2.4 of Annex VII, where possible employed by \nthe notified body itself. \nThe personnel refer red to in Sections 3.2.3 and 3.2.7 of Annex VII shall be emplo yed by the notifi ed body itself and \nshall not be external exper ts or subcontractors. \n2. Notified bodies shall mak e available and submit upon request all relevant documentation, including the manufac \nturer's documentation, to the author ity responsible for notified bodies to allow it to conduct its assessment, designation, \nnotificati on, monit oring and surveillance activities and to facilitate the assessment outlined in this Chapt er. \n3. In order to ensure the unif orm application of the requirements set out in Annex VII, the Commission may adopt \nimplementing acts, to the extent necessar y to resolve issues of diverge nt interpretat ion and of practical application. \nThose implementing acts shall be adopt ed in accordance with the examination procedure referred to in Article 114(3)."
},
"Article 37": {
"heading": "Subsidiaries and subcontracting",
"text": "1. Where a notified body subcontracts specific tasks connected with conf ormity assessment or has recourse to \na subsidiar y for specifi c tasks connected with conf ormity assessment, it shall verify that the subcontractor or the \nsubsidiar y meets the applicable requirements set out in Annex VII and shall inform the author ity responsible for notifi ed \nbodies according ly. \n2. Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontract ors or \nsubsidiar ies. \n3. Notified bodies shall make publicly available a list of their subsidiar ies. \n4. Conf ormity assessment activities may be subcontracte d or carried out by a subsidiar y provided that the legal or \nnatural person that applied for conf ormity assessment has been informed according ly. \n5. Notified bodies shall keep at the disposal of the author ity responsible for notifi ed bodies all relevant documents \nconcer ning the verification of the qualifications of the subcontractor or the subsidiar y and the work carried out by them \nunder this Regulation."
},
"Article 38": {
"heading": "Application by conformity assessment bodies for designation",
"text": "1. Conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies. 2. The application shall specify the conformity assessment activities as defined in this Regulation, and the types of devices for which the body is applying to be designated, and shall be supported by documentation demonstrating compliance with Annex VII. In respect of the organisational and general requirements and the quality management requirements set out in Sections 1 and 2 of Annex VII, a valid accreditation certificate and the corresponding evaluation report delivered by a national accreditation body in accordance with Regulation (EC) No 765/2008 may be submitted and shall be taken into consideration during the assessment described in Article 39. However, the applicant shall make available all the documentation referred to in the first subparagraph to demonstrate compliance with those requirements upon request. 3. The notified body shall update the documentation referred to in paragraph 2 whenever relevant changes occur, in order to enable the authority responsible for notified bodies to monitor and verify continuous compliance with all the requirements set out in Annex VII."
},
"Article 39": {
"heading": "Assessment of the application",
"text": "1. The authority responsible for notified bodies shall within 30 days check that the application referred to in Article 38 is complete and shall request the applicant to provide any missing information. Once the application is complete that authority shall send it to the Commission. The authority responsible for notified bodies shall review the application and supporting documentation in accordance with its own procedures and shall draw up a preliminary assessment report. 2. The authority responsible for notified bodies shall submit the preliminary assessment report to the Commission which shall immediately transmit it to the MDCG. 3. Within 14 days of the submission referred to in paragraph 2 of this Article, the Commission, in conjunction with the MDCG, shall appoint a joint assessment team made up of three experts, unless the specific circumstances require a different number of experts, chosen from the list referred to in Article 40(2). One of the experts shall be a representative of the Commission who shall coordinate the activities of the joint assessment team. The other two experts shall come from Member States other than the one in which the applicant conformity assessment body is established. The joint assessment team shall be comprised of experts who are competent to assess the conformity assessment activities and the types of devices which are the subject of the application or, in particular when the assessment procedure is initiated in accordance with Article 47(3), to ensure that the specific concern can be appropriately assessed. 4. Within 90 days of its appointment, the joint assessment team shall review the documentation submitted with the application in accordance with Article 38. The joint assessment team may provide feedback to, or require clarification from, the authority responsible for notified bodies on the application and on the planned on-site assessment. The authority responsible for notified bodies together with the joint assessment team shall plan and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or subcontractor, located inside or outside the Union, to be involved in the conformity assessment process. The on-site assessment of the applicant body shall be led by the authority responsible for notified bodies. 5. Findings regarding non-compliance of an applicant conformity assessment body with the requirements set out in Annex VII shall be raised during the assessment process and discussed between the authority responsible for notified bodies and the joint assessment team with a view to reaching consensus and resolving any diverging opinions, with respect to the assessment of the application. At the end of the on-site assessment, the authority responsible for notified bodies shall list for the applicant conformity assessment body the non-compliances resulting from the assessment and summarise the assessment by the joint assessment team. Within a specified timeframe, the applicant conformity assessment body shall submit to the national authority a corrective and preventive action plan to address the non-compliances. 6. The joint assessment team shall document any remaining diverging opinions with respect to the assessment within 30 days of completion of the on-site assessment and send them to the authority responsible for notified bodies. 7. The authority responsible for notified bodies shall following receipt of a corrective and preventive action plan from the applicant body assess whether non-compliances identified during the assessment have been appropriately addressed. This plan shall indicate the root cause of the identified non-compliances and shall include a timeframe for implemen tation of the actions therein. The authority responsible for notified bodies shall having confirmed the corrective and preventive action plan forward it and its opinion thereon to the joint assessment team. The joint assessment team may request of the authority responsible for notified bodies further clarification and modifications. The authority responsible for notified bodies shall draw up its final assessment report which shall include: — the result of the assessment, — confirmation that the corrective and preventive actions have been appropriately addressed and, where required, implemented, — any remaining diverging opinion with the joint assessment team, and, where applicable, — the recommended scope of designation. 8. The authority responsible for notified bodies shall submit its final assessment report and, if applicable, the draft designation to the Commission, the MDCG and the joint assessment team. 9. The joint assessment team shall provide a final opinion regarding the assessment report prepared by the authority responsible for notified bodies and, if applicable, the draft designation within 21 days of receipt of those documents to the Commission, which shall immediately submit that final opinion to the MDCG. Within 42 days of receipt of the opinion of the joint assessment team, the MDCG shall issue a recommendation with regard to the draft designation, which the authority responsible for notified bodies shall duly take into consideration for its decision on the designation of the notified body. 10. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements specifying procedures and reports for the application for designation referred to in Article 38 and the assessment of the application set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3)."
},
"Article 4": null,
"Article 40": {
"heading": "Nomination of experts for joint assessment of applications for notification",
"text": "1. The Member State s and the Commission shall nominate exper ts qualified in the assessment of conf ormity \nassessment bodies in the field of medical devices to participat e in the activities refer red to in Articles 39 and 48. \n2. The Commission shall maintain a list of the exper ts nominated pursuant to paragraph 1 of this Article, together \nwith information on their specific field of competence and expertise. That list shall be made available to Member States \ncompetent authorities through the electronic system refer red to in Article 57."
},
"Article 41": {
"heading": "Language requirements",
"text": "All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languag es which shall be \ndetermined by the Member State concer ned. \nMember State s, in applying the first paragraph, shall consider accepti ng and using a commonly understood language in \nthe medical field, for all or part of the documentation concer ned. \nThe Commission shall provide translations of the documentation pursuant to Articles 38 and 39, or parts thereof into \nan official Union language, such as is necessar y for that documentation to be readily underst ood by the joint assessment \nteam appointed in accordance with Article 39(3)."
},
"Article 42": {
"heading": "Designation and notification procedure",
"text": "Designation and notif ication procedure \n1. Member State s may only designat e conf ormity assessment bodies for which the assessment pursuant to Article 39 \nwas complet ed and which compl y with Annex VII. \n2. Member States shall notify the Commission and the other Member States of the conf ormity assessment bodies they \nhave designated, using the electronic notifi cation tool within the database of notified bodies developed and manage d by \nthe Commission (NANDO). \n3. The notifi cation shall clearly specify , using the codes referred to in paragraph 13 of this Article, the scope of the \ndesignation indicating the conf ormity assessment activities as defined in this Regulation and the types of devices whic h \nthe notified body is author ised to assess and, without prejudice to Article 44, any conditions associated with the \ndesignation. 5.5.2017 L 117/43 Official Jour nal of the European Union EN \n 4. The notifi cation shall be accompan ied by the final assessment repor t of the author ity responsible for notifi ed \nbodies, the final opinion of the joint assessment team refer red to in Article 39(9) and the recommendation of the \nMDCG. Where the notifying Member State does not follow the recommendation of the MDCG, it shall provide a duly \nsubstantiated justif ication. \n5. The notifying Member State shall, without prejudice to Article 44, inform the Commission and the other \nMember States of any conditions associated with the designation and provide documentar y evidence regarding the \narrang ements in place to ensure that the notified body will be monitored regularly and will continue to satisfy the \nrequirements set out in Annex VII. \n6. Within 28 days of the notificati on referred to in paragraph 2, a Member State or the Commission may raise \nwritten objections, setting out its arguments, with regar d either to the notifi ed body or to its monitori ng by the \nauthor ity responsible for notified bodies. Where no objection is raised, the Commission shall publish in NANDO the \nnotificati on within 42 days of its having been notified as refer red to in paragraph 2. \n7. When a Member State or the Commission raises objections in accordance with paragraph 6, the Commission shall \nbring the matter before the MDCG within 10 days of the expir y of the period refer red to in paragraph 6. After \nconsulting the parties involved, the MDCG shall give its opinion at the latest within 40 days of the matt er having been \nbrought before it. Where the MDCG is of the opinion that the notificati on can be accept ed, the Commission shall \npublish in NANDO the notifi cation within 14 days. \n8. Where the MDCG, after having been consulted in accordance with paragraph 7, conf irms the existing objection or \nraises another objection, the notifying Member State shall provide a written response to the MDCG opinion within \n40 days of its receipt. The response shall address the objections raised in the opinion, and set out the reasons for the \nnotifying Member State 's decision to designat e or not designate the conf ormity assessment body . \n9. Where the notifying Member State decides to uphold its decision to designate the conf ormity assessment body , \nhaving given its reasons in accordance with paragraph 8, the Commission shall publish in NANDO the notifi cation \nwithin 14 days of being informed thereof. \n10. When publishing the notificati on in NANDO, the Commission shall also add to the electronic system referred to \nin Article 57 the information relating to the notifi cation of the notifi ed body along with the documents mentioned in \nparagraph 4 of this Article and the opinion and responses referred to in paragraphs 7 and 8 of this Article. \n11. The designation shall become valid the day after the notification is published in NANDO. The published \nnotificati on shall state the scope of lawful conf ormity assessment activity of the notifi ed body . \n12. The conf ormity assessment body concer ned may perform the activities of a notifi ed body only after the \ndesignation has become valid in accordance with paragraph 11. \n13. The Commission shall by 26 November 2017, by means of implementing acts, draw up a list of codes and \ncorresponding types of devices for the purpose of specifying the scope of the designation of notified bodies. Those \nimplementing acts shall be adopt ed in accordance with the examination procedure refer red to in Article 114(3). The \nCommission, after consulting the MDCG, may updat e this list based, inter alia, on information arising from the \ncoordination activities descr ibed in Article 48."
},
"Article 43": {
"heading": "Identification number and list of notified bodies",
"text": "Identification number and list of notif ied bodies \n1. The Commission shall assign an identif ication number to each notified body for which the notifi cation becomes \nvalid in accordance with Article 42(11). It shall assign a sing le identif ication number even when the body is notified \nunder several Union acts. If they are successfully designated in accordance with this Regulation, bodies notified pursuant \nto Directives 90/385/EEC and 93/42/EEC shall retain the identif ication number assigned to them pursuant to those \nDirectives. \n2. The Commission shall make the list of the bodies notified under this Regulation, including the identification \nnumbers that have been assigned to them and the conf ormity assessment activities as defined in this Regulation and the \ntypes of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list \navailable on the electronic system refer red to in Article 57. The Commission shall ensure that the list is kept up to date."
},
"Article 44": {
"heading": "Monitoring and re-assessment of notified bodies",
"text": "1. Notified bodies shall, without dela y, and at the latest within 15 days, inform the author ity responsible for notifi ed \nbodies of relevant changes which may affect their compl iance with the requirements set out in Annex VII or their ability \nto conduct the conf ormity assessment activities relating to the devices for whic h they have been designat ed. \n2. The author ities responsible for notified bodies shall monitor the notifi ed bodies established on their territory and \ntheir subsidiar ies and subcontractors to ensure ongoing compliance with the requirements and the fulfilment of its \noblig ations set out in this Regulation. Notifie d bodies shall, upon request by their author ity responsible for notified \nbodies, supply all relevant information and documents, required to enable the author ity, the Commission and other \nMember States to verify compliance. \n3. Where the Commission or the author ity of a Member State submits a request to a notified body established on the \nterritory of another Member State relating to a conf ormity assessment carried out by that notifi ed body , it shall send \na copy of that request to the author ity responsible for notified bodies of that other Member State . The notified body \nconcer ned shall respond without dela y and within 15 days at the lates t to the request. The author ity responsible for \nnotified bodies of the Member State in whic h the body is established shall ensure that requests submitted by author ities \nof any other Member State or by the Commission are resolved by the notified body unless there is a legitimate reason \nfor not doing so in which case the matt er may be referred to the MDCG. \n4. At least once a year , the author ities responsible for notified bodies shall re-assess whether the notifi ed bodies \nestablished on their respective territory and, where appropr iate, the subsidiar ies and subcontractors under the responsi \nbility of those notifi ed bodies still satisfy the requirements and fulfil their obligations set out in Annex VII. That review \nshall include an on-site audit of each notifi ed body and, where necessar y, of its subsidiar ies and subcontractor s. \nThe author ity responsible for notifi ed bodies shall conduct its monitoring and assessment activities according to an \nannual assessment plan to ensure that it can effectively monitor the continued compl iance of the notified body with the \nrequirements of this Regulation. That plan shall provide a reasoned sche dule for the frequency of assessment of the \nnotified body and, in particular , associated subsidiar ies and subcontractor s. The author ity shall submit its annual plan \nfor monit oring or assessment for each notified body for which it is responsible to the MDCG and to the Commission. \n5. The monitori ng of notified bodies by the author ity responsible for notifi ed bodies shall include obser ved audits of \nnotified body personnel, including where necessar y any personnel from subsidiar ies and subcontract ors, as that \npersonnel is in the process of conducting quality manage ment system assessments at a manufa cturer's facility . \n6. The monit oring of notifi ed bodies conduct ed by the author ity responsible for notifi ed bodies shall consider data \narising from mark et surveillance, vigilance and post-market surveillance to help guide its activities. \nThe author ity responsible for notified bodies shall provide for a systematic follow-up of compl aints and other \ninformation, including from other Member State s, which may indicate non-fulfilment of the obligations by a notified \nbody or its deviation from common or best practice. \n7. The author ity responsible for notified bodies may in addition to regular monitori ng or on-site assessments conduct \nshor t-notice, unannounced or ‘for-cause ’ reviews if needed to address a particular issue or to verify compl iance. \n8. The author ity responsible for notifi ed bodies shall review the assessments by notified bodies of manufact urers' \ntechnical documentation, in particular the clinical evaluation documentation as further outlined in Article 45. \n9. The author ity responsible for notified bodies shall document and record any findings regar ding non-com pliance of \nthe notifi ed body with the requirements set out in Annex VII and shall monitor the timely implementation of corrective \nand preventive actions. \n10. Three years after notifi cation of a notified body , and again ever y fourth year thereaf ter, a compl ete re-assessment \nto determine whether the notified body still satisfi es the requirements set out in Annex VII shall be conduct ed by the \nauthor ity responsible for notifi ed bodies of the Member State in which the body is established and by a joint assessment \nteam appointed for the purpose of the procedure descr ibed in Articles 38 and 39. 5.5.2017 L 117/45 Official Jour nal of the European Union EN \n 11. The Commission is empowered to adopt delegat ed acts in accordance with Article 115 in order to amend \nparagraph 10 to modify the frequency at whic h the compl ete re-assessment refer red to in that paragraph is to be carried \nout. \n12. The Member States shall repor t to the Commission and to the MDCG, at least once a year, on their monitori ng \nand on-site assessment activities rega rding notified bodies and, where applicable, subsidiar ies and subcontractors. The \nrepor t shall provide details of the outcome of those activities, including activities pursuant to paragraph 7, and shall be \ntreated as confidential by the MDCG and the Commission; however it shall contain a summar y which shall be made \npublicly available. \nThe summar y of the repor t shall be uploaded to the electronic system referred to in Article 57."
},
"Article 45": {
"heading": "Review of notified body assessment of technical documentation and clinical evaluation documentation",
"text": "Review of notif ied body assessment of technical documentation and clinical evaluation \ndocumentation \n1. The author ity responsible for notified bodies, as part of its ongoing monitori ng of notified bodies, shall review an \nappropr iate number of notifi ed body assessments of manuf acturers' technical documentation, in particular the clinical \nevaluation documentation as refer red to in points (c) and (d) of Section 6.1 of Annex II to verify the conclusions drawn \nby the notified body based on the information present ed by the manufacturer . The reviews by the author ity responsible \nfor notified bodies shall be conduct ed both off-site and on-site. \n2. The sampling of files to be reviewed in accordance with paragraph 1 shall be planned and representative of the \ntypes and risk of devices certified by the notified body , in particular high-r isk devices, and be appropr iately justif ied and \ndocumented in a sampli ng plan, which shall be made available by the author ity responsible for notified bodies to the \nMDCG upon request. \n3. The author ity responsible for notifi ed bodies shall review whether the assessment by the notifi ed body was \nconduct ed appropr iately and shall chec k the procedures used, associated documentation and the conclusions drawn by \nthe notified body . Such checking shall include the technical documentation and clinical evaluation documentation of the \nmanufa cturer upon which the notifi ed body has based its assessment. Such reviews shall be conduct ed utilising CS. \n4. Those reviews shall also form part of the re-assessment of notified bodies in accordance with Article 44(10) and \nthe joint assessment activities refer red to in Article 47(3). The reviews shall be conduct ed utilising appropr iate exper tise. \n5. Based on the repor ts of the reviews and assessments by the author ity responsible for notified bodies or joint \nassessment teams, on input from the mark et surveillance, vigilance and post-market surveillance activities descr ibed in \nChapt er VII, on the continuous monitor ing of technical progress, or on the identif ication of concer ns and emerging \nissues concer ning the safety and performa nce of devices, the MDCG may recommend that the sampli ng, carried out \nunder this Article, cover a greate r or lesser propor tion of the technical documentation and clinical evaluation documen \ntation assessed by a notifi ed body . \n6. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements, \nassociated documents for, and coordination of, the review of assessments of technical documentation and clinical \nevaluation documentation, as referred to in this Article. Those imple menting acts shall be adopt ed in accordance with \nthe examination procedure refer red to in Article 114(3)."
},
"Article 46": {
"heading": "Changes to designations and notifications",
"text": "1. The authority responsible for notified bodies shall notify the Commission and the other Member States of any relevant changes to the designation of a notified body. The procedures described in Article 39 and in Article 42 shall apply to extensions of the scope of the designation. For changes to the designation other than extensions of its scope, the procedures laid down in the following paragraphs shall apply. 2. The Commission shall immediately publish the amended notification in NANDO. The Commission shall immediately enter information on the changes to the designation of the notified body in the electronic system referred to in Article 57. 3. Where a notified body decides to cease its conformity assessment activities it shall inform the authority responsible for notified bodies and the manufacturers concerned as soon as possible and in the case of a planned cessation one year before ceasing its activities. The certificates may remain valid for a temporary period of nine months after cessation of the notified body's activities on condition that another notified body has confirmed in writing that it will assume responsibilities for the devices covered by those certificates. The new notified body shall complete a full assessment of the devices affected by the end of that period before issuing new certificates for those devices. Where the notified body has ceased its activity, the authority responsible for notified bodies shall withdraw the designation. 4. Where a authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VII, or that it is failing to fulfil its obligations or has not implemented the necessary corrective measures, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A suspension shall not exceed a period of one year, renewable once for the same period. The authority responsible for notified bodies shall immediately inform the Commission and the other Member States of any suspension, restriction or withdrawal of a designation. 5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the manufacturers concerned at the latest within 10 days. 6. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall take appropriate steps to ensure that the files of the notified body concerned are kept and make them available to authorities in other Member States responsible for notified bodies and to authorities responsible for market surveillance at their request. 7. In the event of restriction, suspension or withdrawal of a designation, the authority responsible for notified bodies shall: (a) assess the impact on the certificates issued by the notified body; (b) submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation; (c) require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued to ensure the safety of devices on the market; (d) enter into the electronic system referred to in Article 57 information in relation to certificates of which it has required their suspension or withdrawal; (e) inform the competent authority for medical devices of the Member State in which the manufacturer has its registered place of business through the electronic system referred to in Article 57 of the certificates for which it has required suspension or withdrawal. That competent authority shall take the appropriate measures, where necessary to avoid a potential risk to the health or safety of patients, users or others. 8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in the following circumstances: (a) the authority responsible for notified bodies has confirmed, within one month of the suspension or restriction, that there is no safety issue in relation to certificates affected by the suspension or restriction, and the authority responsible for notified bodies has outlined a timeline and actions anticipated to remedy the suspension or restriction; or (b) the authority responsible for notified bodies has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction. In the event that the authority responsible for notified bodies determines that the notified body does not have the capability to support existing certificates issued, the manufacturer shall provide, to the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business, within three months of the suspension or restriction, a written confirmation that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction. 9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months in the following circumstances: (a) where the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its registered place of business has confirmed that there is no safety issue associated with the devices in question; and (b) another notified body has confirmed in writing that it will assume immediate responsibilities for those devices and will have completed assessment of them within twelve months of the withdrawal of the designation. In the circumstances referred to in the first subparagraph, the competent authority for medical devices of the Member State in which the manufacturer of the device covered by the certificate has its place of business may extend the provisional validity of the certificates for further periods of three months, which altogether shall not exceed twelve months. The authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof."
},
"Article 47": {
"heading": "Challenge to the competence of notified bodies",
"text": "1. The Commission, in conjunction with the MDCG, shall inve stigat e all cases where concer ns have been brought to \nits attention regar ding the continued fulfilme nt by a notified body , or of one or more of its subsidiar ies or subcon \ntract ors, of the requirements set out in Annex VII or the oblig ations to which they are subject. It shall ensure that the \nrelevant author ity responsible for notified bodies is informed and is given an oppor tunity to investigat e those concer ns. \n2. The notifying Member State shall provide the Commission, on request, with all information regar ding the \ndesignation of the notified body concer ned. \n3. The Commission, in conjunction with the MDCG, may initiate, as applicable, the assessment procedure descr ibed \nin Article 39(3) and (4), where there is reasonable concer n about the ongoing compl iance of a notifi ed body or \na subsidiar y or subcontractor of the notifi ed body with the requirements set out in Annex VII and where the inve sti\ngation by the author ity responsible for notified bodies is not deemed to have fully addressed the concer ns or upon \nrequest of the author ity responsible for notified bodies. The repor ting and outcome of that assessment shall follow the \nprinciples of Article 39. Alternatively , depending on the sever ity of the issue, the Commission, in conjunction with the \nMDCG, may request that the author ity responsible for notified bodies allow the participation of up to two exper ts from \nthe list established pursuant to Article 40 in an on-site assessment as part of the planned monitori ng and assessment \nactivities in accordance with Article 44 and as outlined in the annual assessment plan descr ibed in Article 44(4). \n4. Where the Commission ascer tains that a notifi ed body no long er meets the requirements for its designation, it \nshall inform the notifying Member State according ly and request it to take the necessar y corrective measures, including \nthe suspension, restr iction or withdrawal of the designation if necessar y. \nWhere the Member State fails to take the necessar y corrective measures, the Commission may, by means of \nimplementing acts, suspend, restr ict or withdraw the designation. Those implementing acts shall be adopt ed in \naccordance with the examination procedure referred to in Article 114(3). It shall notify the Member State concer ned of \nits decision and update NANDO and the electronic system refer red to in Article 57. \n5. The Commission shall ensure that all confidential information obtained in the course of its investigat ions is treated \naccordingly."
},
"Article 48": {
"heading": "Peer review and exchange of experience between authorities responsible for notified bodies",
"text": "1. The Commission shall provide for the organisation of exchang e of exper ience and coordination of administrative \npractice between the author ities responsible for notified bodies. Such exchang e shall cover elements including: \n(a) development of best practice documents relating to the activities of the author ities responsible for notified bodies; 5.5.2017 L 117/48 Official Jour nal of the European Union EN \n (b) development of guidance documents for notifi ed bodies in relation to the imp lementation of this Regulation; \n(c) training and qualifi cation of the exper ts refer red to in Article 40; \n(d) monitori ng of trends relating to changes to notifi ed body designations and notificati ons and trends in certificate \nwithdrawa ls and transfer s between notifi ed bodies; \n(e) monitori ng of the application and applicability of scope codes refer red to in Article 42(13); \n(f) development of a mec hanism for peer reviews between author ities and the Commission; \n(g) methods of communication to the public on the monitori ng and surveillance activities of author ities and the \nCommission on notifi ed bodies. \n2. The author ities responsible for notified bodies shall participate in a peer review ever y third year through the \nmech anism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with \nthe on-site joint assessments descr ibed in Article 39. Alter natively , an author ity may mak e the choice of having such \nreviews take place as part of its monitori ng activities referred to in Article 44. \n3. The Commission shall participate in the organisati on and provide suppor t to the implementation of the peer \nreview mec hanism. \n4. The Commission shall compi le an annual summar y repor t of the peer review activities, whic h shall be made \npublicly available. \n5. The Commission may, by means of imple menting acts, adopt measures setting out the detailed arrange ments and \nrelat ed documents for the peer review mecha nism and training and qualification as refer red to in paragraph 1 of this \nArticle. Those implementing acts shall be adop ted in accordance with the examination procedure refer red to in Article 114(3)"
},
"Article 49": {
"heading": "Coordination of notified bodies",
"text": "The Commission shall ensure that appropr iate coordination and cooperation between notified bodies is put in place and \noperat ed in the form of a coordination group of notified bodies in the field of medical devices, including in vitro \ndiagnostic medical devices. This group shall meet on a regular basis and at least annually . \nThe bodies notified under this Regulation shall participate in the work of that group. \nThe Commission may establish the specific arrang ements for the functioning of the coordination group of notified \nbodies."
},
"Article 5": null,
"Article 50": {
"heading": "List of standard fees",
"text": "List of standard fees \nNotified bodies shall establish lists of their standard fees for the conformity assessment activities that they carry out and \nshall make those lists publicly available."
},
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Notified bodies"
}
|
{
"text": "out in Sections 14 and 15 conf orm to the type descr ibed in the EU type-examination certificate and meet the \nrequirements of this Regulation which apply to them. \n12. The manufacturer shall take all the measures necessar y to ensure that the manufa ctur ing process produces \ndevices whic h conf orm to the type descr ibed in the EU type-examination certificate and to the requirements of \nthe Regulation which apply to them. Prior to the start of manufacture, the manufacturer shall prepare documents \ndefining the manufa ctur ing process, in particular as regards sterilis ation where necessar y, together with all \nroutine, pre-established procedures to be implemented to ensure homog eneous production and, where \nappropr iate, conf ormity of the devices with the type descr ibed in the EU type-examination certificate and with \nthe requirements of this Regulation which apply to them. \nIn addition, for devices placed on the mark et in a steri le condition, and only for those aspects of the manuf actur \ning process designed to secure and maintain steri lity, the manufacturer shall apply the provisions of Sections 6 \nand 7. \n13. The manufa cturer shall under take to institute and keep up to date a post-market surveillance plan, including \na PMCF plan, and the procedures ensur ing compliance with the oblig ations of the manufact urer resulting from \nthe provisions on vigilance and post-market surveillance system set out in Chapt er VII. \n14. The notified body shall carry out the appropr iate examinations and tests in order to verify the conf ormity of the \ndevice with the requirements of the Regulation by examining and testing ever y product as specified in \nSection 15. \nThe examinations and tests referred to in the first paragraph of this Section shall not apply to aspects of the \nmanufactur ing process designed to secure steri lity. \n15. Verification by examination and testing of ever y product \n15.1. Ever y device shall be examined individually and the appropr iate physical or laboratory tests as defined in the \nrelevant standard or standards refer red to in Article 8, or equivalent tests and assessments, shall be carried out in \norder to verify, where appropr iate, the conf ormity of the devices with the type descr ibed in the EU type- \nexamination certificate and with the requirements of this Regulation whic h apply to them. 5.5.2017 L 117/159 Official Jour nal of the European Union EN \n 15.2. The notified body shall affix, or have affixed, its identif ication number to each appro ved device and shall draw \nup an EU product verification certificate relating to the tests and assessments carried out. \n16. Batch verification in the case of devices incor porating, as an integral part, a medicinal substance whic h, if used \nseparately , would be considered to be a medicinal product derived from human blood or human plasma refer red \nto in Article 1(8). \nUpon compl eting the manufacture of each batch of devices that incor porat e, as an integral part, a medicinal \nsubstance which , if used separately , would be considered to be a medicinal product derived from human blood \nor human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notifi ed \nbody of the release of the batch of devices and send it the official certificate concer ning the release of the batch \nof human blood or plasma derivative used in the device, issued by a Member State laboratory or a laborat ory \ndesignated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC. \n17. Administrative provisions \nThe manufa cturer or its author ised representative shall, for a period ending no sooner than 10 years, and in the \ncase of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at \nthe disposal of the compet ent author ities: \n— the EU declaration of conf ormity , \n— the documentation refer red to in Section 12, \n— the certificate refer red to in Section 15.2, and \n— the EU type-examination certificate refer red to in Annex X. \nSection 8 of Annex IX shall apply . \n18. Application to class IIa devices \n18.1. By way of deroga tion from Section 11, by virtue of the EU declaration of conf ormity the manuf acturer shall be \ndeemed to ensure and to declare that the class IIa devices in question are manuf actured in conf ormity with the \ntechnical documentation refer red to in Annex es II and III and meet the requirements of this Regulation which \napply to them. \n18.2. The verification conducted by the notified body in accordance with Section 14 is intended to confir m the \nconf ormity of the class IIa devices in question with the technical documentation refer red to in Annex es II and III \nand with the requirements of this Regulation whic h apply to them. \n18.3. If the verification refer red to in Section 18.2 conf irms that the class IIa devices in question conf orm to the \ntechnical documentation refer red to in Annex es II and III and meet the requirements of this Regulation which \napply to them, the notified body shall issue a certificate pursuant to this Part of this Annex. \n18.4. By way of deroga tion from Section 17, the manufacturer or its author ised representative shall, for a period \nending no sooner than 10 years after the last device has been placed on the mark et, keep at the disposal of the \ncompet ent author ities: \n— the EU declaration of conf ormity , \n— the technical documentation refer red to in Annexes II and III, and \n— the certificate refer red to in Section 18.3. \nSection 8 of Annex IX shall apply . 5.5.2017 L 117/160 Official Jour nal of the European Union EN",
"title": "Annex IV, shall be deemed to ensure and to declare that the devices whic h have been subject to the procedure set"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 34": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": {
"heading": "Classification of devices",
"text": "1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and \ntheir inherent risks. Classification shall be carried out in accordance with Annex VIII. 5.5.2017 L 117/49 Official Jour nal of the European Union EN \n 2. Any dispute between the manuf acturer and the notifi ed body concer ned, arising from the application of \nAnnex VIII, shall be referred for a decision to the compet ent author ity of the Member State in whic h the manufacturer \nhas its register ed place of business. In cases where the manufacturer has no register ed place of business in the Union and \nhas not yet designat ed an author ised representative, the matt er shall be refer red to the compe tent author ity of the \nMember State in which the author ised representative refer red to in the last indent of point (b) of the second \nparagraph of Section 2.2 of Annex IX has its register ed place of business. Where the notified body concer ned is \nestablished in a Member State other than that of the manufacturer , the compet ent author ity shall adopt its decision after \nconsultation with the compet ent author ity of the Member State that designate d the notified body . \nThe compet ent author ity of the Member State in whic h the manuf acturer has its registere d place of business shall notify \nthe MDCG and the Commission of its decision. The decision shall be made available upon request. \n3. At the request of a Member State the Commission shall after consulting the MDCG, decide, by means of \nimplementing acts, on the following: \n(a) application of Annex VIII to a given device, or categor y or group of devices, with a view to deter mining the classifi \ncation of such devices; \n(b) that a device, or categor y or group of devices, shall for reasons of public health based on new scientific evidence, or \nbased on any information whic h becomes available in the course of the vigilance and mark et surveillance activities \nbe reclassif ied, by way of deroga tion from Annex VIII. \n4. The Commission may also, on its own initiative and after consulting the MDCG, decide, by means of \nimplementing acts, on the issues refer red to in points (a) and (b) of paragraph 3. \n5. In order to ensure the unif orm application of Annex VIII, and taking account of the relevant scientifi c opinions of \nthe relevant scientifi c committees, the Commission may adopt implementing acts to the extent necessar y to resolve \nissues of diverg ent interpretat ion and of practical application. \n6. The implementing acts referred to in paragraphs 3, 4 and 5 of this Article shall be adopt ed in accordance with the \nexamination procedure refer red to in Article 114(3). \nSECTION 2 \nConf ormity assessment"
},
"Article 52": {
"heading": "Conformity assessment procedures",
"text": "Article 52(10). \n7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating compet ent \nauthor ity shall, through the electronic system refer red to in Article 92, inform, without dela y, the other compet ent \nauthor ities of the corrective action taken or envisaged by the manuf acturer or required of it to minimise the risk of \nrecur rence of the serious incident, including information on the underlying events and the outcome of its assessment. \n8. The manuf acturer shall ensure that information about the field safety corrective action taken is brought without \ndela y to the attention of users of the device in question by means of a field safet y notice. The field safety notice shall be \nedited in an official Union languag e or languages determined by the Member State in whic h the field safety corrective \naction is taken. Excep t in cases of urgency , the conte nt of the draf t field safety notice shall be submitte d to the \nevaluating compet ent author ity or, in the cases refer red to in paragraph 9, to the coordinating compet ent author ity to \nallow it to make comments. Unless duly justif ied by the situation of the individual Member State, the conte nt of the field \nsafety notice shall be consistent in all Member State s. \nThe field safety notice shall allow the correct identif ication of the device or devices involved, in particular by including \nthe relevant UDIs, and the correct identif ication, in particular , by including the SRN, if already issued, of the \nmanufa cturer that has under taken the field safet y corrective action. The field safety notice shall explain, in a clear \nmanner , without understating the level of risk, the reasons for the field safet y corrective action with reference to the \ndevice malfunction and associated risks for patients, users or other persons, and shall clearly indicate all the actions to \nbe taken by users. \nThe manuf acturer shall enter the field safety notice in the electronic system referred to in Article 92 through which that \nnotice shall be accessible to the public. \n9. The compe tent author ities shall actively participate in a procedure in order to coordinate their assessments refer red \nto in paragraph 3 in the following cases: \n(a) where there is concer n regarding a particular serious incident or cluster of serious incidents relating to the same \ndevice or type of device of the same manufacturer in more than one Member State; 5.5.2017 L 117/75 Official Jour nal of the European Union EN \n (b) where the appropr iateness of a field safety corrective action that is proposed by a manuf acturer in more than one \nMember State is in question. \nThat coordinated procedure shall cover the following: \n— designation of a coordinating compet ent author ity on a case by case basis, when required; \n— defining the coordinat ed assessment process, including the tasks and responsibilities of the coordinating compet ent \nauthor ity and the involvement of other compet ent author ities. \nUnless other wise agreed between the compe tent author ities, the coordinating compet ent author ity shall be the \ncompet ent author ity of the Member State in whic h the manufa cturer has its registered place of business. \nThe coordinating compet ent author ity shall, through the electronic system referred to in Article 92, inform the \nmanufa cturer , the other compet ent author ities and the Commission that it has assumed the role of coordinating \nauthor ity. \n10. The designation of a coordinating compet ent author ity shall not affect the rights of the other compet ent \nauthor ities to perf orm their own assessment and to adopt measures in accordance with this Regulation in order to \nensure the prote ction of public health and patient safety . The coordinating compet ent author ity and the Commission \nshall be kept informed of the outcome of any such assessment and the adopt ion of any such measures. \n11. The Commission shall provide administrative suppor t to the coordinating compet ent author ity in the \naccompl ishment of its tasks under this Chapt er."
},
"Article 53": {
"heading": "Involvement of notified bodies in conformity assessment procedures",
"text": "Article 53 \nInvolvement of notif ied bodies in confor mity assessment procedures \n1. Where the conf ormity assessment procedure requires the involvement of a notified body , the manuf acturer may \napply to a notified body of its choice, provided that the chosen notified body is designate d for conf ormity assessment \nactivities relat ed to the types of devices concer ned. The manuf acturer may not lodg e an application in parallel with \nanother notified body for the same conf ormity assessment procedure. \n2. The notifi ed body concer ned shall, by means of the electronic system refer red to in Article 57, inform the other \nnotified bodies of any manufacturer that withdra ws its application prior to the notified body's decision regar ding the \nconf ormity assessment. \n3. When applying to a notified body under paragraph 1, manufacturers shall declare whether they have withdra wn \nan application with another notified body prior to the decision of that notified body and provide information about any \nprevious application for the same conf ormity assessment that has been refused by another notifi ed body . \n4. The notified body may require any information or data from the manuf acturer , which is necessar y in order to \nproperly conduct the chosen conf ormity assessment procedure. \n5. Notified bodies and the personnel of notified bodies shall carry out their conf ormity assessment activities with the \nhighest degree of profess ional integr ity and the requisite technical and scientific compet ence in the specifi c field and \nshall be free from all pressures and inducements, particularly financial, whic h might influence their judg ement or the \nresults of their conf ormity assessment activities, especially as regards persons or groups with an inter est in the results of \nthose activities."
},
"Article 54": {
"heading": "Clinical evaluation consultation procedure for certain class III and class IIb devices",
"text": "Article 54(1) and Article 61(2) and Section 5.1 of Annex IX or Section 6 of Annex X, as applicable. \n10. Exper t panels and exper t laborat ories may have the following task s, depending on the requisit e needs: \n(a) to provide scientific, technical and clinical assistance to the Commission and the MDCG in relation to the implemen \ntation of this Regulation; \n(b) to contr ibut e to the development and maint enance of appropr iate guidance and CS for: \n— clinical investig ations, \n— clinical evaluation and PMCF , \n— performance studies, \n— performance evaluation and post-market perf ormance follow-up, \n— physico-chem ical charact erisation, and \n— microbiological, biocompat ibility , mech anical, electr ical, electronic or non-clinical toxicological testin g \nfor specific devices, or a categor y or group of devices, or for specifi c hazards related to a categor y or group of \ndevices; \n(c) to develop and review clinical evaluation guidance and performa nce evaluation guidance for performa nce of \nconf ormity assessment in line with the state of the art with regar d to clinical evaluation, perf ormance evaluation, \nphysico-chemical character isation, and microbiological, biocom patibility , mechanical, electr ical, electronic or non- \nclinical toxicological testing; \n(d) to contr ibute to the development of standards at international level, ensur ing that such standards reflect the state of \nthe art; \n(e) to provide opinions in response to consultations by manufacturers in accordance with Article 61(2), notifi ed bodies \nand Member States in accordance with paragraphs 11 to 13 of this Article. \n(f) to contr ibut e to identification of concer ns and emerging issues on the safety and performa nce of medical devices; \n(g) to provide views in accordance with Article 48(4) of Regulation (EU) 2017/746 on the performa nce evaluation of \ncertain in vitro diagnostic medical devices. \n11. The Commission, shall facilitate the access of Member States and notified bodies and manufa cturers to advice \nprovided by exper t panels and exper t laborat ories concer ning, inter alia, the criteria for an appropr iate data set for \nassessment of the conf ormity of a device, in particular with regard to the clinical data required for clinical evaluation, \nwith regar d to physico-c hemical charact erisation, and with regar d to microbiological, biocom patibility , mechanical, \nelectr ical, electronic and non-clinical toxicological testing. \n12. When adopting its scientific opinion in accordance with paragraph 9, the members of the exper t panels shall use \ntheir best endeav ours to reach consensus. If consensus cannot be reach ed, the exper t panels shall decide by a majority of \ntheir members, and the scientific opinion shall mention the diverg ent positions and the grounds on which they are \nbased. \nThe Commission shall publish the scientifi c opinion and advice delivered in accordance with paragraphs 9 and 11 of \nthis Article, ensur ing consideration of aspects of conf identiality as set out in Article 109. The clinical evaluation \nguidance refer red to in point (c) of paragraph 10 shall be published following consultation with the MDCG. \n13. The Commission may require manufacturers and notifi ed bodies to pay fees for the advice provided by exper t \npanels and exper t laboratories. The structure and the level of fees as well as the scale and structure of reco verable costs \nshall be adopt ed by the Commission by means of implementing acts, taking into account the objectives of the adequat e \nimplementation of this Regulation, prot ection of health and safety, suppor t of inno vation and cost-effe ctiveness and the \nnecessity to achieve active participation in the exper t panels. Those implementing acts shall be adopt ed in accordance \nwith the examination procedure refer red to in Article 114(3). 5.5.2017 L 117/85 Official Jour nal of the European Union EN \n 14. The fees payable to the Commission in accordance with the procedure under paragraph 13 of this Article shall \nbe set in a transparent manner and on the basis of the costs for the services provided. The fees payable shall be reduced \nin the case of a clinical evaluation consultation procedure initiated in accordance with point (c) of Section 5.1 of \nAnnex IX involving a manufa cturer who is a micro, small or medium-sized enterprise within the meaning of \nRecommendation 2003/361/EC. \n15. The Commission is empo wered to adopt delegat ed acts in accordance with Article 115 to amend the tasks of \nexper t panels and exper t laboratori es refer red to in paragraph 10 of this Article."
},
"Article 55": {
"heading": "Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices",
"text": "Article 55 \nMechanism for scrutiny of confor mity assessments of certain class III and class IIb devices \n1. A notified body shall notify the compet ent author ities of certificates it has grant ed to devices for which the \nconf ormity assessment has been perf ormed pursuant to Article 54(1). Such notifi cation shall take place through the \nelectronic system referred to in Article 57 and shall include the summar y of safety and clinical perf ormance pursuant to"
},
"Article 56": {
"heading": "Certificates of conformity",
"text": "Article 56 \nCer tificates of confo rmity \n1. The certificates issued by the notified bodies in accordance with Annex es IX, X and XI shall be in an official Union \nlanguag e determined by the Member State in which the notified body is established or other wise in an official Union \nlanguag e acceptab le to the notifi ed body . The minimum cont ent of the certificates shall be as set out in Annex XII. \n2. The certificates shall be valid for the period they indicate, whic h shall not exceed five years. On application by the \nmanufa cturer , the validity of the certificate may be extende d for further periods, each not exceeding five years, based on \na re-assessment in accordance with the applicable conf ormity assessment procedures. Any supplement to a certificate \nshall remain valid as long as the certificate which it supplements is valid. \n3. Notified bodies may imp ose restr ictions to the intended purpose of a device to certain groups of patients or \nrequire manufacturers to under take specif ic PMCF studies pursuant to Part B of Annex XIV. 5.5.2017 L 117/53 Official Jour nal of the European Union EN \n 4. Where a notifi ed body finds that the requirements of this Regulation are no longer met by the manuf acturer , it \nshall, taking account of the principle of propor tionality , suspend or withdra w the certificate issued or impose any \nrestr ictions on it unless compl iance with such requirements is ensured by appropr iate corrective action taken by the \nmanufa cturer within an appropr iate deadline set by the notified body . The notified body shall give the reasons for its \ndecision. \n5. The notified body shall enter in the electronic system refer red to in Article 57 any information rega rding \ncertificates issued, including amendments and supplements thereto, and regar ding suspended, reinstated , withdrawn or \nrefused certificates and restr ictions imposed on certificates. Such information shall be accessible to the public. \n6. In the light of technical progress, the Commission is empowered to adopt delegat ed acts in accordance with"
},
"Article 57": {
"heading": "Electronic system on notified bodies and on certificates of conformity",
"text": "Article 57 \nElectronic system on notif ied bodies and on certificates of conformity \n1. The Commission, after consulting the MDCG, shall set up and manage an electronic system to collat e and process \nthe following information: \n(a) the list of subsidiar ies referred to in Article 37(3); \n(b) the list of exper ts referred to in Article 40(2); \n(c) the information relating to the notifi cation refer red to in Article 42(10) and the amended notifications refer red to in"
},
"Article 58": {
"heading": "Voluntary change of notified body",
"text": "Article 58 \nVolunta ry change of notif ied body \n1. In cases where a manufacturer term inates its contract with a notifi ed body and enters into a contract with another \nnotified body in respect of the conf ormity assessment of the same device, the detailed arrang ements for the change of \nnotified body shall be clearly defined in an agreement between the manuf acturer , the incoming notified body and, where \npracticable the outgoing notified body . That agreement shall cover at least the following aspects: \n(a) the date on whic h the certificates issued by the outgoing notifi ed body become invalid; \n(b) the date until which the identif ication number of the outgoing notifi ed body may be indicated in the information \nsupplied by the manufa cturer , including any promotional mate rial; \n(c) the transfer of documents, including conf identiality aspects and proper ty rights; \n(d) the date after which the conf ormity assessment tasks of the outgoing notifi ed body is assigned to the incoming \nnotified body ; \n(e) the last serial number or lot number for whic h the outgoing notified body is responsible. \n2. The outgoing notifi ed body shall withdra w the certificates it has issued for the device concer ned on the date on \nwhic h they become invalid. 5.5.2017 L 117/54 Official Jour nal of the European Union EN"
},
"Article 59": {
"heading": "Derogation from the conformity assessment procedures",
"text": "Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once \na delegat ed act has been adopt ed by the Commission pursuant to the first subparagraph of Article 5(3) of \nRegulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the \ncriteria that are relevant to human health amongst the criteria established therein. \n10.4.2. Justifi cation regarding the presence of CMR and/or endocr ine-disr upti ng substances \nThe justification for the presence of such substances shall be based upon: \n(a) an analysis and estimation of potential patient or user exposure to the substance; \n(b) an analysis of possible alternati ve substances, mater ials or designs, including, where available, information \nabout independent research, peer -reviewed studies, scientific opinions from relevant scientific committees \nand an analysis of the availability of such alternati ves; \n(c) argumentation as to why possible substance and/ or mater ial substitutes, if available, or design change s, if \nfeasible, are inappropr iate in relation to maintaining the functionality , performa nce and the benefi t-risk \nratios of the product ; including taking into account if the intende d use of such devices includes treatment \nof children or treatment of pregnant or breastf eeding women or treatment of other patient groups \nconsidered particularly vulnerable to such substances and/or mate rials; and \n(d) where applicable and available, the latest relevant scientific committee guidelines in accordance with \nSections 10.4.3. and 10.4.4. \n10.4.3. Guidelines on phthalat es \nFor the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the \nrelevant scientific committe e with a mandate to prepare guidelines that shall be ready before 26 May 2020. The \nmandate for the committee shall encomp ass at least a benefit-r isk assessment of the presence of phthalates \nwhich belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The \nbenefi t-risk assessment shall take into account the intende d purpose and cont ext of the use of the device, as \nwell as any available altern ative substances and alternative mat erials, designs or medical treatments. When \ndeemed appropr iate on the basis of the latest scientifi c evidence, but at least ever y five years, the guidelines \nshall be update d. 5.5.2017 L 117/96 Official Jour nal of the European Union EN \n(1)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and \npackaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending \nRegulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1). \n(2)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concer ning the Registration, \nEvaluation, Authorisation and Restr iction of Chemicals (REA CH) (OJ L 396, 30.12.2006, p. 1). \n(3)Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concer ning the making avai lable on the \nmarket of and use of biocidal products (OJ L 167, 27.6.2012, p. 1). \n 10.4.4. Guidelines on other CMR and endocr ine-disr upti ng substances \nSubsequently , the Commission shall mandate the relevant scientifi c committee to prepare guidelines as refer red \nto in Section 10.4.3. also for other substances refer red to in points (a) and (b) of Section 10.4.1., where \nappropr iate. \n10.4.5. Labelling \nWhere devices, parts thereof or mater ials used therein as refer red to in Section 10.4.1. contain substances \nrefer red to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the \npresence of those substances shall be labelled on the device itself and/or on the packag ing for each unit or, \nwhere appropr iate, on the sales packag ing, with the list of such substances. If the intended use of such devices \nincludes treatment of children or treatment of pregnant or breastf eeding women or treatment of other patient \ngroups considered particularly vulnerable to such substances and/or mate rials, information on residual risks for \nthose patient groups and, if applicable, on appropr iate precautionar y measures shall be given in the \ninstr uctions for use. \n10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the \nunintentional ingress of substances into the device taking into account the device and the nature of the \nenvi ronment in which it is intended to be used. \n10.6. Devices shall be designed and manuf actured in such a way as to reduce as far as possible the risks linked to the \nsize and the proper ties of particles whic h are or can be released into the patient's or user's body , unless they \ncome into contact with intact skin only . Special attention shall be given to nanomater ials. \n11. Infection and microbial contamination \n11.1. Devices and their manuf actur ing processes shall be designed in such a way as to eliminate or to reduce as far as \npossible the risk of infection to patients, users and, where applicable, other persons. The design shall: \n(a) reduce as far as possible and appropr iate the risks from unintended cuts and pricks, such as needle stick \ninjur ies, \n(b) allow easy and safe handling, \n(c) reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and \n(d) prevent microbial contamination of the device or its content such as specimens or fluids. \n11.2. Where necessar y devices shall be designed to facilitat e their safe cleaning, disinfection, and/or re-st erilisation. \n11.3. Devices labelled as having a specifi c microbial state shall be designed, manuf actured and packag ed to ensure \nthat they remain in that state when placed on the mark et and remain so under the transpor t and storag e \nconditions specifi ed by the manufacturer . \n11.4. Devices delivered in a sterile state shall be designed, manufa ctured and packag ed in accordance with \nappropr iate procedures, to ensure that they are sterile when placed on the mark et and that, unless the \npackag ing which is intended to maintain their sterile condition is damaged, they remain sterile, under the \ntranspor t and stora ge conditions specified by the manufacturer , until that packaging is opened at the point of \nuse. It shall be ensured that the integr ity of that packaging is clearly evident to the final user . \n11.5. Devices labelled as sterile shall be processed, manufactured, packag ed and, sterilis ed by means of appropr iate, \nvalidate d methods. \n11.6. Devices intended to be sterilised shall be manuf actured and packag ed in appropr iate and controlled conditions \nand facilities. \n11.7. Packaging syste ms for non-sterile devices shall maintain the integr ity and cleanliness of the product and, where \nthe devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packag ing system \nshall be suitable taking account of the method of sterilisation indicated by the manuf acturer . 5.5.2017 L 117/97 Official Jour nal of the European Union EN \n 11.8. The labelling of the device shall distinguish between identical or similar devices placed on the mark et in both \na sterile and a non-steri le condition additional to the symbol used to indicate that devices are steri le. \n12. Devices incor porating a substance considered to be a medicinal product and devices that are compo sed of \nsubstances or of combinations of substances that are absorbed by or locally dispersed in the human body . \n12.1. In the case of devices referred to in the first subparagraph of Article 1(8), the quality , safety and usefulness of \nthe substance whic h, if used separately , would be considered to be a medicinal product within the meaning of \npoint (2) of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in \nAnnex I to Directive 2001/83/EC, as required by the applicable conf ormity assessment procedure under this \nRegulation. \n12.2. Devices that are compo sed of substances or of combinations of substances that are intended to be introduced \ninto the human body , and that are absorbed by or locally dispersed in the human body shall comply , where \napplicable and in a manner limited to the aspects not covered by this Regulation, with the relevant \nrequirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absor ption, distr ibution, \nmetabolism, excre tion, local tolerance, toxicity , intera ction with other devices, medicinal products or other \nsubstances and potential for adverse reactions, as required by the applicable conf ormity assessment procedure \nunder this Regulation. \n13. Devices incor porating mater ials of biological origin \n13.1. For devices manufactured utilising derivatives of tissues or cells of human origin whic h are non-viable or are \nrendered non-viable covered by this Regulation in accordance with point (g) of Article 1(6), the following shall \napply: \n(a) donation, procurement and testing of the tissues and cells shall be done in accordance with \nDirective 2004/23/EC; \n(b) processing, preser vation and any other handling of those tissues and cells or their derivatives shall be \ncarried out so as to provide safety for patients, users and, where applicable, other persons. In particular , \nsafety with regard to viruses and other transmissible agents shall be addressed by appropr iate methods of \nsourcing and by implementation of validat ed methods of elimination or inactivation in the course of the \nmanufactur ing process; \n(c) the traceability system for those devices shall be compl ementar y and compati ble with the traceability and \ndata protection requirements laid down in Directive 2004/23/EC and in Directive 2002/98/EC. \n13.2. For devices manuf actured utilising tissues or cells of animal origin, or their derivatives, whic h are non-viable or \nrendered non-viable the following shall apply: \n(a) where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives, \nshall originat e from animals that have been subjected to veterinar y controls that are adapt ed to the \nintended use of the tissues. Information on the geographical origin of the animals shall be retained by \nmanufacturers; \n(b) sourcing, processing, preser vation, testing and handling of tissues, cells and substances of animal origin, or \ntheir derivatives, shall be carried out so as to provide safety for patients, users and, where applicable, other \npersons. In particular safety with regar d to viruses and other transmissible agents shall be addressed by \nimplementation of validate d methods of elimination or viral inactivation in the course of the manufactur ing \nprocess, excep t when the use of such methods would lead to unaccept able degradation compromising the \nclinical benefit of the device; \n(c) in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as refer red \nto in Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply . \n13.3. For devices manuf actured utilising non-viable biological substances other than those refer red to in \nSections 13.1 and 13.2, the processing, preser vation, testing and handling of those substances shall be carried \nout so as to provide safety for patients, users and, where applicable, other persons, including in the waste \ndisposal chain. In particular , safety with regar d to viruses and other transmissible agents shall be addressed by \nappropr iate methods of sourcing and by implementation of validat ed methods of elimination or inactivation in \nthe course of the manufactur ing process. 5.5.2017 L 117/98 Official Jour nal of the European Union EN \n 14. Constr uction of devices and inter action with their environment \n14.1. If the device is intended for use in combination with other devices or equipment the whole combination, \nincluding the connection system shall be safe and shall not impair the specifi ed perf ormance of the devices. \nAny restr ictions on use applying to such combinations shall be indicate d on the label and/or in the instr uctions \nfor use. Connections which the user has to handle, such as fluid, gas transfer , electr ical or mechanical coupling, \nshall be designed and constr ucted in such a way as to minimise all possible risks, such as misconnection. \n14.2. Devices shall be designed and manufactured in such a way as to remo ve or reduce as far as possible: \n(a) the risk of injur y, in connection with their physical features, including the volume/pressure ratio, \ndimensional and where appropr iate ergonomic features; \n(b) risks connected with reasonably foreseeable external influences or environmental conditions, such as \nmagnetic fields, external electr ical and electromagnetic effects, electrostatic disc harge, radiation associated \nwith diagnostic or therapeutic procedures, pressure, humidity , temperature, variations in pressure and \nacceleration or radio signal interferences; \n(c) the risks associated with the use of the device when it comes into contact with mate rials, liquids, and \nsubstances, including gases, to which it is exposed during normal conditions of use; \n(d) the risks associated with the possible negative inter action between software and the IT environment within \nwhich it operat es and interacts; \n(e) the risks of accidental ingress of substances into the device; \n(f) the risks of reciprocal interfe rence with other devices normally used in the investigat ions or for the \ntreatment given; and \n(g) risks arising where maintenance or calibration are not possible (as with implants), from ageing of mat erials \nused or loss of accuracy of any measur ing or control mechanism. \n14.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during \nnormal use and in sing le fault condition. Particular attention shall be paid to devices the intende d use of whic h \nincludes exposure to or use in association with flammable or explosive substances or substances whic h could \ncause combustion. \n14.4. Devices shall be designed and manuf actured in such a way that adjustment, calibration, and maintenance can \nbe done safely and effectively . \n14.5. Devices that are intended to be operat ed together with other devices or products shall be designed and \nmanufactured in such a way that the interoperability and compati bility are reliable and safe. \n14.6 Any measurement, monitoring or displa y scale shall be designed and manufactured in line with ergonomic \nprinciples, taking account of the intended purpose, users and the envi ronmental conditions in whic h the \ndevices are intende d to be used. \n14.7. Devices shall be designed and manufa ctured in such a way as to facilitate their safe disposal and the safe \ndisposal of related waste substances by the user , patient or other person. To that end, manufacturers shall \nidentify and test procedures and measures as a result of which their devices can be safely disposed after use. \nSuch procedures shall be descr ibed in the instr uctions for use. \n15. Devices with a diagnostic or measur ing function \n15.1. Diagnostic devices and devices with a measur ing function, shall be designed and manufactured in such a way as \nto provide suffi cient accuracy , precision and stability for their intende d purpose, based on appropr iate scientifi c \nand technical methods. The limits of accuracy shall be indicated by the manuf acturer . \n15.2. The measurements made by devices with a measur ing function shall be expressed in legal units conf orming to \nthe provisions of Council Directive 80/181/EEC (1). 5.5.2017 L 117/99 Official Jour nal of the European Union EN \n(1)Council Directive 80/181/EEC of 20 December 1979 on the appro ximation of the laws of the Member States relating to units of \nmeasurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40). \n 16. Protection against radiation \n16.1. General \n(a) Devices shall be designed, manuf actured and packag ed in such a way that exposure of patients, users and \nother persons to radiation is reduced as far as possible, and in a manner that is compatible with the \nintended purpose, whilst not restr icting the application of appropr iate specifi ed levels for therapeutic and \ndiagnostic purposes. \n(b) The operating instr uctions for devices emitting hazardous or poten tially hazardous radiation shall contain \ndetailed information as to the nature of the emitted radiation, the means of prot ecting the patient and the \nuser , and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible \nand appropr iate. Information regar ding the acceptance and performa nce testin g, the acceptance criteria, and \nthe maintenance procedure shall also be specifi ed. \n16.2. Intended radiation \n(a) Where devices are designed to emit hazardous, or poten tially hazardous, levels of ionizing and/or non- \nionizing radiation necessar y for a specific medical purpose the benefi t of which is considered to outweigh \nthe risks inherent to the emission, it shall be possible for the user to control the emissions. Such devices \nshall be designed and manufa ctured to ensure reproducibility of relevant variable parameters within an \nacceptable tolerance. \n(b) Where devices are intended to emit hazardous, or poten tially hazardous, ionizing and/or non-ionizing \nradiation, they shall be fitted, where possible, with visual displa ys and/or audible warnings of such \nemissions. \n16.3. Devices shall be designed and manuf actured in such a way that exposure of patients, users and other persons to \nthe emission of unintend ed, stray or scattered radiation is reduced as far as possible. Where possible and \nappropr iate, methods shall be selecte d whic h reduce the exposure to radiation of patients, users and other \npersons who may be affected. \n16.4. Ionising radiation \n(a) Devices intended to emit ionizing radiation shall be designed and manuf actured taking into account the \nrequirements of the Directive 2013/59/Euratom laying down basic safety standards for protect ion against \nthe dangers arising from exposure to ionising radiation. \n(b) Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure \nthat, where possible, taking into account the intended use, the quantity , geometr y and quality of the \nradiation emitt ed can be varied and controlled, and, if possible, monitor ed during treatment. \n(c) Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in \nsuch a way as to achi eve an image and/or output quality that are appropr iate to the intended medical \npurpose whilst minimising radiation exposure of the patient and user . \n(d) Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed and \nmanufactured in such a way as to enable reliable monitori ng and control of the delivered dose, the beam \ntype, energy and, where appropr iate, the quality of radiation. \n17. Electronic programmable systems — devices that incor porate electronic programmable systems and software \nthat are devices in themselves \n17.1. Devices that incor porate electronic programmable systems, including software, or software that are devices in \nthemselves, shall be designed to ensure repeatability , reliability and performa nce in line with their intended use. \nIn the event of a sing le fault condition, appropr iate means shall be adopt ed to eliminate or reduce as far as \npossible consequent risks or imp airment of performa nce. \n17.2. For devices that incor porat e software or for software that are devices in themselves, the software shall be \ndeveloped and manuf actured in accordance with the state of the art taking into account the principles of \ndevelopment life cycle, risk manag ement, including information secur ity, verification and validation. 5.5.2017 L 117/100 Official Jour nal of the European Union EN \n 17.3. Software refer red to in this Section that is intended to be used in combination with mobile computing \nplatf orms shall be designed and manufactured taking into account the specific features of the mobile platf orm \n(e.g. size and contrast ratio of the screen) and the extern al factors related to their use (var ying environment as \nregards level of light or noise). \n17.4. Manufactur ers shall set out minimum requirements concer ning hardware, IT netw orks character istics and IT \nsecur ity measures, including protection against unauthor ised access, necessar y to run the software as intended. \n18. Active devices and devices connected to them \n18.1. For non-implantable active devices, in the event of a sing le fault condition, appropr iate means shall be adopt ed \nto eliminate or reduce as far as possible consequent risks. \n18.2. Devices where the safety of the patient depends on an intern al power supply shall be equipped with a means of \ndeter mining the state of the power supply and an appropr iate warning or indication for when the capacity of \nthe power supply becomes critical. If necessar y, such warning or indication shall be given prior to the power \nsupply becoming critical. \n18.3. Devices where the safety of the patient depends on an extern al power supply shall include an alarm system to \nsignal any power failure. \n18.4. Devices intended to monitor one or more clinical parameter s of a patient shall be equipped with appropr iate \nalarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's \nstate of health. \n18.5. Devices shall be designed and manufa ctured in such a way as to reduce as far as possible the risks of creating \nelectromagnetic interference which could impair the operation of the device in question or other devices or \nequipment in the intended envi ronment. \n18.6. Devices shall be designed and manuf actured in such a way as to provide a level of intrinsic immunity to electro \nmagnetic interference such that is adequate to enable them to operat e as intended. \n18.7. Devices shall be designed and manuf actured in such a way as to avoid, as far as possible, the risk of accidental \nelectr ic shocks to the patient, user or any other person, both during normal use of the device and in the event \nof a sing le fault condition in the device, provided the device is installed and maintained as indicated by the \nmanufacturer . \n18.8. Devices shall be designed and manuf actured in such a way as to prot ect, as far as possible, against unauthor ised \naccess that could hamper the device from functioning as intended. \n19. Particular requirements for active implantable devices \n19.1. Active implantable devices shall be designed and manufactured in such a way as to remo ve or minimize as far \nas possible: \n(a) risks connected with the use of energy sources with particular reference, where electr icity is used, to \ninsulation, leakage currents and overheating of the devices, \n(b) risks connecte d with medical treatment, in particular those resulting from the use of defibr illators or high- \nfrequency surgical equipment, and \n(c) risks which may arise where mainte nance and calibration are impossible, including: \n— excessiv e increase of leakage currents, \n— ageing of the mater ials used, \n— excess heat generat ed by the device, \n— decreased accuracy of any measur ing or control mechanism. \n19.2. Active implantable devices shall be designed and manuf actured in such a way as to ensure \n— if applicable, the compatibility of the devices with the substances they are intended to administer , and \n— the reliability of the source of energy . 5.5.2017 L 117/101 Official Jour nal of the European Union EN \n 19.3. Active implantable devices and, if appropr iate, their compo nent parts shall be identif iable to allow any \nnecessar y measure to be taken following the disco very of a potential risk in connection with the devices or \ntheir component parts. \n19.4. Active implantable devices shall bear a code by whic h they and their manufa cturer can be unequivocally \nidentif ied (par ticularly with regard to the type of device and its year of manufacture); it shall be possible to read \nthis code, if necessar y, without the need for a surgical operation. \n20. Protection against mechanical and ther mal risks \n20.1. Devices shall be designed and manufa ctured in such a way as to protect patients and users again st mechanical \nrisks connected with, for exam ple, resistance to movement, instability and moving parts. \n20.2. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks \narising from vibration generat ed by the devices, taking account of technical progress and of the means available \nfor limiting vibrations, particularly at source, unless the vibrations are part of the specifi ed performa nce. \n20.3. Devices shall be designed and manufactured in such a way as to reduce to the lowest possible level the risks \narising from the noise emitted , taking account of technical progress and of the means available to reduce noise, \nparticularly at source, unless the noise emitted is part of the specified performa nce. \n20.4. Terminals and connectors to the electr icity , gas or hydraulic and pneumatic energy supplies which the user or \nother person has to handle, shall be designed and constr ucted in such a way as to minimise all possible risks. \n20.5. Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made \nimpossible by the design and constr uction of such parts or, failing this, by information given on the parts \nthemselves and/or their housings. \nThe same information shall be given on moving parts and/or their housings where the direction of movement \nneeds to be kno wn in order to avoid a risk. \n20.6. Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) \nand their surroundings shall not attain poten tially dange rous temperatures under normal conditions of use. \n21. Protection against the risks posed to the patient or user by devices supplying energy or substances \n21.1. Devices for supplying the patient with energy or substances shall be designed and constr ucted in such a way \nthat the amount to be delivered can be set and maintained accurat ely enough to ensure the safety of the patient \nand of the user . \n21.2. Devices shall be fitted with the means of preventing and/or indicating any inadequacies in the amount of \nenergy delivered or substances delivered which could pose a dange r. Devices shall incor porat e suitable means to \nprevent, as far as possible, the accidental release of dang erous levels of energy or substances from an energy \nand/or substance source. \n21.3. The function of the controls and indicators shall be clearly specifi ed on the devices. Where a device bears \ninstr uctions required for its operation or indicates operating or adjustment parameter s by means of a visual \nsystem, such information shall be understandable to the user and, as appropr iate, the patient. \n22. Protection against the risks posed by medical devices intended by the manufa cturer for use by lay persons \n22.1. Devices for use by lay persons shall be designed and manuf actured in such a way that they perform \nappropr iately for their intended purpose taking into account the skills and the means available to lay persons \nand the influence resulting from variation that can be reasonably anticipated in the lay person's technique and \nenvi ronment. The information and instr uctions provided by the manufact urer shall be easy for the lay person \nto understand and apply . 5.5.2017 L 117/102 Official Jour nal of the European Union EN \n 22.2. Devices for use by lay persons shall be designed and manufactured in such a way as to: \n— ensure that the device can be used safely and accurat ely by the intended user at all stages of the procedure, \nif necessar y after appropr iate training and/or information, \n— reduce, as far as possible and appropr iate, the risk from unintend ed cuts and pricks such as needle stick \ninjur ies, and \n— reduce as far as possible the risk of error by the intended user in the handling of the device and, if \napplicable, in the interpr etation of the results. \n22.3. Devices for use by lay persons shall, where appropr iate, include a procedure by whic h the lay person: \n— can verify that, at the time of use, the device will perform as intended by the manuf acturer , and \n— if applicable, is warned if the device has failed to provide a valid result. \nCHAPTER III \nREQUIREMENTS REGARDING THE INFORMA TION SUPPLIED WITH THE DEVICE \n23. Label and instr uctions for use \n23.1. General requirements regarding the information supplied by the manuf acturer \nEach device shall be accompan ied by the information needed to identify the device and its manuf acturer , and \nby any safety and perf ormance information relevant to the user , or any other person, as appropr iate. Such \ninformation may appear on the device itself, on the packag ing or in the instr uctions for use, and shall, if the \nmanufacturer has a website, be made available and kept up to date on the website, taking into account the \nfollowing: \n(a) The medium, format, content, legibility , and location of the label and instr uctions for use shall be \nappropr iate to the particular device, its intende d purpose and the technical knowledge, exper ience, \neducation or training of the intended user(s). In particular , instr uctions for use shall be written in term s \nreadily underst ood by the intended user and, where appropr iate, supplemented with drawings and \ndiagrams. \n(b) The information required on the label shall be provided on the device itself. If this is not practicable or \nappropr iate, some or all of the information may appear on the packag ing for each unit, and/or on the \npackaging of multiple devices. \n(c) Labels shall be provided in a human-readable format and may be supplement ed by mach ine-readable \ninformation, such as radio-frequency identification (‘RFID’) or bar codes. \n(d) Instr uctions for use shall be provided together with devices. By way of excep tion, instr uctions for use shall \nnot be required for class I and class IIa devices if such devices can be used safely without any such \ninstr uctions and unless other wise provided for elsewhere in this Section. \n(e) Where multiple devices are supplied to a sing le user and/or location, a sing le copy of the instr uctions for \nuse may be provided if so agreed by the purc haser who in any case may request further copies to be \nprovided free of charg e. \n(f) Instr uctions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and \nonly under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing \nrules adopt ed pursuant to this Regulation. \n(g) Residual risks which are required to be communicated to the user and/or other person shall be included as \nlimitations, contra-indications, precautions or warnings in the information supplied by the manufacturer . \n(h) Where appropr iate, the information supplied by the manufacturer shall take the form of intern ationally \nrecognised symbols. Any symbol or identification colour used shall conf orm to the harmonised standards \nor CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be descr ibed \nin the documentation supplied with the device. 5.5.2017 L 117/103 Official Jour nal of the European Union EN \n 23.2. Information on the label \nThe label shall bear all of the following particulars: \n(a) the name or trade name of the device; \n(b) the details strictly necessar y for a user to identify the device, the conte nts of the packag ing and, where it is \nnot obvious for the user , the intended purpose of the device; \n(c) the name, registere d trade name or register ed trade mark of the manufacturer and the address of its \nregistered place of business; \n(d) if the manufact urer has its registere d place of business outside the Union, the name of the author ised rep\nresentative and address of the registere d place of business of the author ised representative; \n(e) where applicable, an indication that the device contains or incor porat es: \n— a medicinal substance, including a human blood or plasma derivative, or \n— tissues or cells, or their derivatives, of human origin, or \n— tissues or cells of animal origin, or their derivatives, as refer red to in Regulation (EU) No 722/2012; \n(f) where applicable, information labelled in accordance with Section 10.4.5.; \n(g) the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL \nNUMBER or an equivalent symbol, as appropr iate; \n(h) the UDI carrier referred to in Article 27(4) and Part C of Annex VII; \n(i) an unambiguous indication of t the time limit for using or implanting the device safely , expressed at least \nin term s of year and month, where this is relevant ; \n(j) where there is no indication of the date until when it may be used safely , the date of manuf acture. This \ndate of manufa cture may be included as part of the lot number or serial number , provided the date is \nclearly identif iable; \n(k) an indication of any special storag e and/or handling condition that applies; \n(l) if the device is supplied sterile, an indication of its steril e state and the sterilis ation method; \n(m) warnings or precautions to be taken that need to be brought to the immediate attenti on of the user of the \ndevice, and to any other person. This information may be kept to a minimum in which case more detailed \ninformation shall appear in the instr uctions for use, taking into account the intended users; \n(n) if the device is intende d for sing le use, an indication of that fact. A manufacturer's indication of sing le use \nshall be consistent across the Union; \n(o) if the device is a sing le-use device that has been reprocessed, an indication of that fact, the number of \nreprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles; \n(p) if the device is custom-made, the words ‘custom-made device’; \n(q) an indication that the device is a medical device. If the device is intended for clinical investigat ion only , the \nwords ‘exclusively for clinical investigation’; \n(r) in the case of devices that are compo sed of substances or of combinations of substances that are intended \nto be introduced into the human body via a body orifice or applied to the skin and that are absorbed by \nor locally dispersed in the human body , the overall qualitative compo sition of the device and quantitative \ninformation on the main constituent or constituents responsible for achi eving the principal intende d \naction; \n(s) for active implantable devices, the serial number , and for other implantable devices, the serial number or \nthe lot number . \n23.3. Information on the packag ing which maintains the steri le condition of a device (‘sterile packag ing’) \nThe following particulars shall appear on the sterile packag ing: \n(a) an indication permitting the steri le packag ing to be recognised as such, \n(b) a declaration that the device is in a steril e condition, 5.5.2017 L 117/104 Official Jour nal of the European Union EN \n (c) the method of steril isation, \n(d) the name and address of the manuf acturer , \n(e) a descr iption of the device, \n(f) if the device is intended for clinical inve stigations, the words ‘exclusively for clinical investigations’, \n(g) if the device is custom-made, the words ‘custom-made device’, \n(h) the month and year of manuf acture, \n(i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in \nterm s of year and month, and \n(j) an instr uction to check the instr uctions for use for what to do if the steril e packaging is damage d or \nunintentionally opened before use. \n23.4. Information in the instr uctions for use \nThe instr uctions for use shall contain all of the following particulars: \n(a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2; \n(b) the device's intended purpose with a clear specifi cation of indications, contra-indications, the patient target \ngroup or groups, and of the intended users, as appropr iate; \n(c) where applicable, a specifi cation of the clinical benefits to be expecte d. \n(d) where applicable, links to the summar y of safety and clinical performa nce refer red to in Article 32; \n(e) the performa nce character istics of the device; \n(f) where applicable, information allowing the healthcare profes sional to verify if the device is suitable and \nselect the corresponding software and accessor ies; \n(g) any residual risks, contra-indications and any undesirable side-effects, including information to be \nconve yed to the patient in this regar d; \n(h) specifi cations the user requires to use the device appropr iatel y, e.g. if the device has a measur ing function, \nthe degree of accuracy claimed for it; \n(i) details of any preparatory treatment or handling of the device before it is ready for use or during its use, \nsuch as sterilis ation, final assembly , calibration, etc., including the levels of disinf ection required to ensure \npatient safety and all available methods for achieving those levels of disinf ection; \n(j) any requirements for special facilities, or special training, or particular qualifications of the device user \nand/or other persons; \n(k) the information needed to verify whether the device is properly installed and is ready to perform safely \nand as intended by the manuf acturer , together with, where relevant: \n— details of the nature, and frequency , of preventive and regular mainte nance, and of any preparat ory \ncleaning or disinf ection, \n— identif ication of any consumable compo nents and how to replace them, \n— information on any necessar y calibration to ensure that the device operat es properly and safely during \nits intende d lifetime, and \n— methods for eliminating the risks encount ered by persons involved in installing, calibrating or \nservicing devices; \n(l) if the device is supplied steri le, instr uctions in the event of the sterile packag ing being damaged or \nunintentionally opened before use; 5.5.2017 L 117/105 Official Jour nal of the European Union EN \n (m) if the device is supplied non-steri le with the intention that it is sterilised before use, the appropr iate \ninstr uctions for sterilisation; \n(n) if the device is reusable, information on the appropr iate processes for allowing reuse, including cleaning, \ndisinfection, packa ging and, where appropr iate, the validat ed method of re-st erilisation appropr iate to the \nMember State or Member State s in which the device has been placed on the market. Information shall be \nprovided to identify when the device should no long er be reused, e.g. signs of mate rial degradation or the \nmaximum number of allowable reuses; \n(o) an indication, if appropr iate, that a device can be reused only if it is reconditioned under the responsibility \nof the manufacturer to compl y with the general safety and perf ormance requirements; \n(p) if the device bears an indication that it is for sing le use, information on kno wn character istics and \ntechnical factors kno wn to the manufa cturer that could pose a risk if the device were to be re-used. This \ninformation shall be based on a specifi c section of the manuf acturer's risk manage ment documentation, \nwhere such charact eristics and technical factors shall be addressed in detail. If in accordance with point (d) \nof Section 23.1. no instr uctions for use are required, this information shall be made available to the user \nupon request ; \n(q) for devices intended for use together with other devices and/or general purpose equipment: \n— information to identify such devices or equipment, in order to obtain a safe combination, and/or \n— information on any kno wn restr ictions to combinations of devices and equipment ; \n(r) if the device emits radiation for medical purposes: \n— detailed information as to the nature, type and where appropr iate, the intensity and distr ibution of the \nemitted radiation, \n— the means of protecting the patient, user , or other person from unint ended radiation during use of the \ndevice; \n(s) information that allows the user and/or patient to be informed of any warnings, precautions, contra- \nindications, measures to be take n and limitations of use regarding the device. That information shall, \nwhere relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, \nmeasures to be take n and limitations of use regarding the device. The information shall cover, where \nappropr iate: \n— warnings, precautions and/or measures to be taken in the event of malfunction of the device or \nchanges in its performa nce that may affect safety , \n— warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable \nexternal influences or environmental conditions, such as magnetic fields, extern al electr ical and electro \nmagnetic effects, electrostatic disc harge, radiation associated with diagnostic or therapeutic procedures, \npressure, humidity , or temperature, \n— warnings, precautions and/or measures to be taken as regar ds the risks of interference posed by the \nreasonably foreseeable presence of the device during specific diagnostic investig ations, evaluations, or \ntherapeutic treatment or other procedures such as electromagnetic interference emitt ed by the device \naffecting other equipment, \n— if the device is intended to administe r medicinal products, tissues or cells of human or animal origin, \nor their derivatives, or biological substances, any limitations or incompati bility in the choice of \nsubstances to be delivered, \n— warnings, precautions and/or limitations related to the medicinal substance or biological mater ial that \nis incor porated into the device as an integral part of the device; and \n— precautions related to mater ials incor porat ed into the device that contain or consist of CMR substances \nor endocr ine-disr upti ng substances, or that could result in sensitisation or an allergic reaction by the \npatient or user; 5.5.2017 L 117/106 Official Jour nal of the European Union EN \n (t) in the case of devices that are compo sed of substances or of combinations of substances that are intended \nto be introduced into the human body and that are absorbed by or locally dispersed in the human body , \nwarnings and precautions, where appropr iate, relat ed to the general profile of interaction of the device and \nits products of metabolism with other devices, medicinal products and other substances as well as contra- \nindications, undesirable side-eff ects and risks relating to overdose; \n(u) in the case of implantable devices, the overall qualitative and quantitative information on the mater ials and \nsubstances to whic h patients can be exposed; \n(v) warnings or precautions to be taken in order to facilitat e the safe disposal of the device, its accessor ies and \nthe consumables used with it, if any. This information shall cover, where appropr iate: \n— infection or microbial hazards such as explants, needles or surgical equipment contaminated with \npoten tially infectious substances of human origin, and \n— physical hazards such as from shar ps. \nIf in accordance with the point (d) of Section 23.1 no instr uctions for use are required, this information \nshall be made available to the user upon request ; \n(w) for devices intended for use by lay persons, the circumstances in which the user should consult \na healthcare professional; \n(x) for the devices covered by this Regulation pursuant to Article 1(2), information regar ding the absence of \na clinical benefi t and the risks relat ed to use of the device; \n(y) date of issue of the instr uctions for use or, if they have been revised, date of issue and identifier of the \nlatest revision of the instr uctions for use; \n(z) a notice to the user and/or patient that any serious incident that has occur red in relation to the device \nshould be repor ted to the manufacturer and the compe tent author ity of the Member State in whic h the \nuser and/or patient is established; \n(aa) information to be supplied to the patient with an implant ed device in accordance with Article 18; \n(ab) for devices that incor porat e electronic programmable systems, including software, or software that are \ndevices in themselves, minimum requirements concer ning hardware, IT netw orks charact eristics and IT \nsecur ity measures, including protection against unauthor ised access, necessar y to run the software as \nintended. 5.5.2017 L 117/107 Official Jour nal of the European Union EN \n ANNEX II \nTECHNIC AL DOCUMENT ATION \nThe technical documentation and, if applicable, the summar y thereof to be drawn up by the manuf acturer shall be \npresent ed in a clear , organised, readily searc hable and unambiguous manner and shall include in particular the elements \nlisted in this Annex. \n1. DEVICE DESCRIPTION AND SPECIFIC ATION, INCLUDING VARIANTS AND ACCESSORIES \n1.1. Device descr iption and specification \n(a) product or trade name and a general descr iption of the device including its intended purpose and intended \nusers; \n(b) the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, \nas soon as identif ication of this device becomes based on a UDI system, or other wise a clear identification by \nmeans of product code, catalogue number or other unambiguous reference allowing traceability ; \n(c) the intended patient population and medical conditions to be diagnosed, treated and/or monit ored and other \nconsiderations such as patient selection criteria, indications, contra-indications, warnings; \n(d) principles of operation of the device and its mode of action, scientifi cally demonstrated if necessar y; \n(e) the rationale for the qualifi cation of the product as a device; \n(f) the risk class of the device and the justif ication for the classificat ion rule(s) applied in accordance with \nAnnex VIII; \n(g) an explanation of any novel features; \n(h) a descr iption of the accessor ies for a device, other devices and other products that are not devices, whic h are \nintended to be used in combination with it; \n(i) a descr iption or compl ete list of the various configurations/var iants of the device that are intended to be made \navailable on the mark et; \n(j) a general descr iption of the key functional elements, e.g. its parts/componen ts (including software if \nappropr iate), its formulation, its composition, its functionality and, where relevant, its qualitative and \nquantitative compo sition. Where appropr iate, this shall include labelled pictorial representations (e.g. diagrams, \nphotog raphs, and drawings), clearly indicating key parts/componen ts, including suffi cient explanation to \nunderstand the drawings and diagrams; \n(k) a descr iption of the raw mater ials incor porate d into key functional elements and those making either direct \ncontact with the human body or indirect contact with the body , e.g., during extracor poreal circulation of body \nfluids; \n(l) technical specific ations, such as features, dimensions and performa nce attributes, of the device and any \nvariants/configur ations and accessor ies that would typically appear in the product specif ication made available \nto the user , for exam ple in broch ures, catalogues and similar publications. \n1.2. Reference to previous and similar generations of the device \n(a) an overview of the previous generation or generations of the device produced by the manufa cturer , where such \ndevices exist ; \n(b) an overview of identified similar devices available on the Union or internati onal markets, where such devices \nexist. \n2. INFORMA TION TO BE SUPPLIED BY THE MANUF ACTURER \nA complet e set of: \n— the label or labels on the device and on its packag ing, such as sing le unit packag ing, sales packaging, transpor t \npackaging in case of specifi c manage ment conditions, in the language s accept ed in the Member State s where the \ndevice is envi saged to be sold; and 5.5.2017 L 117/108 Official Jour nal of the European Union EN \n — the instr uctions for use in the languag es accept ed in the Member State s where the device is envisaged to be \nsold. \n3. DESIGN AND MANUF ACTURING INFORMA TION \n(a) information to allow the design stages applied to the device to be understood; \n(b) compl ete information and specifi cations, including the manuf actur ing processes and their validation, their \nadjuvants, the continuous monitoring and the final product testing. Data shall be fully included in the technical \ndocumentation; \n(c) identification of all sites, including suppliers and sub-contractor s, where design and manufactur ing activities are \nperformed. \n4. GENERAL SAFET Y AND PERFORMANCE REQUIREMENTS \nThe documentation shall contain information for the demonstration of conf ormity with the general safety and \nperf ormance requirements set out in Annex I that are applicable to the device taking into account its intended \npurpose, and shall include a justification, validation and verification of the solutions adopt ed to meet those \nrequirements. The demonstration of conf ormity shall include: \n(a) the general safety and perf ormance requirements that apply to the device and an explanation as to why others \ndo not apply ; \n(b) the method or methods used to demonstrate conf ormity with each applicable general safety and performance \nrequirement ; \n(c) the harmonised standards, CS or other solutions applied; and \n(d) the precise identity of the controlled documents offer ing evidence of conf ormity with each harmonised \nstandard, CS or other method applied to demonstrate conf ormity with the general safet y and performance \nrequirements. The information refer red to under this point shall incor porate a cross-reference to the location of \nsuch evidence within the full technical documentation and, if applicable, the summar y technical documentation. \n5. BENEFIT -RISK ANAL YSIS AND RISK MANA GEMENT \nThe documentation shall contain information on: \n(a) the benefit-r isk analysis refer red to in Sections 1 and 8 of Annex I, and \n(b) the solutions adop ted and the results of the risk manage ment refer red to in Section 3 of Annex I. \n6. PRODUCT VERIFICA TION AND VALID ATION \nThe documentation shall contain the results and critical analyses of all verifications and validation tests and/or \nstudies under taken to demonstrate conf ormity of the device with the requirements of this Regulation and in \nparticular the applicable general safet y and performa nce requirements. \n6.1. Pre-clinical and clinical data \n(a) results of tests, such as engineer ing, laboratory , simulat ed use and animal tests, and evaluation of published \nliterature applicable to the device, taking into account its intende d purpose, or to similar devices, regarding the \npre-clinical safety of the device and its conf ormity with the specifi cations; \n(b) detailed information regar ding test design, compl ete test or study protocols, methods of data analysis, in \naddition to data summar ies and test conclusions regar ding in particular: \n— the biocompat ibility of the device including the identif ication of all mater ials in direct or indirect contact \nwith the patient or user; \n— physical, chemical and microbiological character isation; \n— electr ical safet y and electromagnetic compati bility ; 5.5.2017 L 117/109 Official Jour nal of the European Union EN \n — software verification and validation (descr ibing the software design and development process and evidence \nof the validation of the software, as used in the finished device. This information shall typically include the \nsummar y results of all verification, validation and testing perf ormed both in-house and in a simulat ed or \nactual user environment prior to final release. It shall also address all of the diffe rent hardware conf ig\nurations and, where applicable, operating syste ms identified in the information supplied by the \nmanuf acturer); \n— stability , including shelf life; and \n— perf ormance and safety . \nWhere applicable, conf ormity with the provisions of Directive 2004/10/EC of the European Parliament and of \nthe Council (1) shall be demonstrate d. \nWhere no new testing has been under taken, the documentation shall incor porat e a rationale for that decision. \nAn examp le of such a rationale would be that biocompatibility testing on identical mater ials was conducted \nwhen those mat erials were incor porated in a previous version of the device that has been legally placed on the \nmark et or put into service; \n(c) the clinical evaluation repor t and its update s and the clinical evaluation plan referred to in Article 61(12) and \nPart A of Annex XIV; \n(d) the PMCF plan and PMCF evaluation repor t refer red to in Part B of Annex XIV or a justification why a PMCF is \nnot applicable. \n6.2. Additional information required in specific cases \n(a) Where a device incor porates, as an integral part, a substance which , if used separately , may be considered to be \na medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal \nproduct derived from human blood or human plasma, as refer red to in the first subparagraph of Article 1(8), \na statement indicating this fact. In this case, the documentation shall identify the source of that substance and \ncontain the data of the tests conduct ed to assess its safety , quality and usefulness, taking account of the \nintende d purpose of the device. \n(b) Where a device is manufactured utilising tissues or cells of human or animal origin, or their derivatives, and is \ncovered by this Regulation in accordance with points (f) and (g) of Article 1(6, and where a device incor porate s, \nas an integral part, tissues or cells of human origin or their derivatives that have an action ancillar y to that of \nthe device and is covered by this Regulation in accordance with the first subparagraph of Article 1(10), \na state ment indicating this fact. In such a case, the documentation shall identify all mater ials of human or \nanimal origin used and provide detailed information concer ning the conf ormity with Sections 13.1. or 13.2., \nrespectively , of Annex I. \n(c) In the case of devices that are compo sed of substances or combinations of substances that are intended to be \nintroduced into the human body and that are absorbed by or locally dispersed in the human body , detailed \ninformation, including test design, complet e test or study protocols, methods of data analysis, and data \nsummar ies and test conclusions, regarding studies in relation to: \n— absor ption, distr ibution, metabolism and excretion; \n— possible inter actions of those substances, or of their products of metabolism in the human body , with other \ndevices, medicinal products or other substances, consider ing the target population, and its associated \nmedical conditions; \n— local tolerance; and \n— toxicity , including sing le-dose toxicity , repeat-dose toxicity , genoto xicity , carcinog enicity and reproductive \nand developmental toxicity , as applicable depending on the level and nature of exposure to the device. \nIn the absence of such studies, a justification shall be provided. \n(d) In the case of devices containing CMR or endocr ine-disr upting substances refer red to in Section 10.4.1 of \nAnnex I, the justification refer red to in Section 10.4.2 of that Annex. 5.5.2017 L 117/110 Official Jour nal of the European Union EN \n(1)Directive 2004/10/EC of the European Parliament and of the Council of 11 Febr uary 2004 on the harmonisation of laws, regulations \nand administrative provisions relating to the application of the principles of good laboratory practice and the verification of their \napplications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44). \n (e) In the case of devices placed on the mark et in a steri le or defined microbiological condition, a descr iption of \nthe environmental conditions for the relevant manufactur ing step s. In the case of devices placed on the mark et \nin a steri le condition, a descr iption of the methods used, including the validation repor ts, with respect to \npackag ing, steri lisation and maintenanc e of sterilit y. The validation repor t shall address bioburden testing, \npyrogen testing and, if applicable, testing for steri lant residues. \n(f) In the case of devices placed on the mark et with a measur ing function, a descr iption of the methods used in \norder to ensure the accuracy as given in the specifi cations. \n(g) If the device is to be connecte d to other device(s) in order to operat e as intended, a descr iption of this \ncombination/configuration including proof that it conf orms to the general safety and performa nce \nrequirements when connected to any such device(s) having regar d to the charact eristics specified by the \nmanuf acturer . 5.5.2017 L 117/111 Official Jour nal of the European Union EN \n ANNEX III \nTEC HNIC AL DOCUMENT ATION ON POST -MARKET SUR VEILL ANCE \nThe technical documentation on post-market surveillance to be drawn up by the manuf acturer in accordance with \nArticles 83 to 86 shall be present ed in a clear , organised, readily searc hable and unambiguous manner and shall include \nin particular the elements descr ibed in this Annex. \n1.1. The post-market surveillance plan drawn up in accordance with Article 84. \nThe manufacturer shall prove in a post-market surveillance plan that it compl ies with the obligation referred to \nin Article 83. \n(a) The post-market surveillance plan shall address the collection and utilization of available information, in \nparticular: \n— information concer ning serious incidents, including information from PSURs, and field safety corrective \nactions; \n— records refer ring to non-ser ious incidents and data on any undesirable side-eff ects; \n— information from trend repor ting; \n— relevant specialist or technical literature, databases and/or register s; \n— information, including feedbacks and complaints, provided by users, distr ibut ors and impor ters; and \n— publicly available information about similar medical devices. \n(b) The post-market surveillance plan shall cover at least : \n— a proactive and syste matic process to collect any information refer red to in point (a). The process shall \nallow a correct charact erisation of the perf ormance of the devices and shall also allow a compari son to \nbe made between the device and similar products available on the market ; \n— effective and appropr iate methods and processes to assess the collected data; \n— suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- \nrisk analysis and of the risk managemen t as referred to in Section 3 of Annex I; \n— effective and appropr iate methods and tools to investig ate compl aints and analyse mark et-related \nexper ience collect ed in the field; \n— methods and protocols to manage the events subject to the trend repor t as provided for in Article 88, \nincluding the methods and prot ocols to be used to establish any statistically signif icant increase in the \nfrequency or sever ity of incidents as well as the obser vation period; \n— methods and protocols to communicate effectively with compet ent author ities, notifi ed bodies, economic \noperat ors and users; \n— reference to procedures to fulfil the manuf acturers oblig ations laid down in Articles 83, 84 and 86; \n— system atic procedures to identify and initiate appropr iate measures including corrective actions; \n— effective tools to trace and identify devices for which corrective actions might be necessar y; and \n— a PMCF plan as refer red to in Part B of Annex XIV, or a justif ication as to why a PMCF is not applicable. \n1.2. The PSUR refer red to in Article 86 and the post-market surveillance repor t refer red to in Article 85. 5.5.2017 L 117/112 Official Jour nal of the European Union EN \n ANNEX IV \nEU DECL ARA TION OF CONFORMIT Y \nThe EU declaration of conf ormity shall contain all of the following information: \n1. Name, register ed trade name or registere d trade mark and, if already issued, SRN as referred to in Article 31 of the \nmanufa cturer , and, if applicable, its author ised representative, and the address of their registered place of business \nwhere they can be contacted and their location be established; \n2. A state ment that the EU declaration of conf ormity is issued under the sole responsibility of the manuf acturer ; \n3. The Basic UDI-DI as refer red to in Part C of Annex VI; \n4. Product and trade name, product code, catalogue number or other unambiguous reference allowing identif ication \nand traceability of the device covered by the EU declaration of conf ormity , such as a photograph, where \nappropr iate, as well as its intende d purpose. Except for the product or trade name, the information allowing identif i\ncation and traceability may be provided by the Basic UDI-DI refer red to in point 3; \n5. Risk class of the device in accordance with the rules set out in Annex VIII; \n6. A state ment that the device that is covered by the present declaration is in conf ormity with this Regulation and, if \napplicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of \nconf ormity ; \n7. References to any CS used and in relation to whic h conf ormity is declared; \n8. Where applicable, the name and identif ication number of the notified body , a descr iption of the conf ormity \nassessment procedure performed and identif ication of the certificate or certificates issued; \n9. Where applicable, additional information; \n10. Place and date of issue of the declaration, name and function of the person who signed it as well as an indication \nfor, and on behalf of whom, that person signed, signature. 5.5.2017 L 117/113 Official Jour nal of the European Union EN \n ANNEX V \nCE MARKING OF CONFORMIT Y \n1. The CE marking shall consist of the initials ‘CE’ taking the following form: \n2. If the CE marking is reduced or enlarg ed, the propor tions given in the above graduat ed drawing shall be respected . \n3. The various components of the CE marking shall have substantially the same vertical dimension, whic h may not be \nless than 5 mm. This minimum dimension may be waived for small-scale devices. 5.5.2017 L 117/114 Official Jour nal of the European Union EN \n ANNEX VI \nINFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS IN ACCORD ANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED \nTO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORD ANCE WITH ART ICLES 28 AND 29, \nAND THE UDI SYSTEM \nPART A \nINFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS IN ACCORD ANCE WITH ARTICLES 29(4) AND 31 \nManufactur ers or, when applicable, author ised representatives, and, when applicable, impor ters shall submit the \ninformation refer red to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is \ncompl ete, correct and updated by the relevant party. \n1. Information relating to the economic operat or \n1.1. type of economic operat or(manuf acturer , author ised representative, or impor ter), \n1.2. name, address and contact details of the economic operat or, \n1.3. where submission of information is carried out by another person on behalf of any of the economic operat ors \nmentioned under Section 1.1, the name, address and contact details of that person, \n1.4. name address and contact details of the person or persons responsible for regulatory compl iance refer red to in"
},
"Article 6": null,
"Article 60": {
"heading": "Certificate of free sale",
"text": "Article 60 \nCer tificate of free sale \n1. For the purpose of expor t and upon request by a manufacturer or an author ised representative, the Member State \nin whic h the manufa cturer or the author ised representative has its register ed place of business shall issue a certificate of \nfree sale declar ing that the manufacturer or the author ised representative, as applicable, has its register ed place of \nbusiness on its territory and that the device in question bear ing the CE marking in accordance with this Regulation may \nbe market ed in the Union. The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the \nUDI database under Article 29. Where a notifi ed body has issued a certificate pursuant to Article 56, the certificate of \nfree sale shall set out the unique number identifying the certificate issued by the notified body , as referred to in \nSection 3 of Chapt er II of Annex XII. \n2. The Commission may, by means of implemen ting acts, establish a model for certificates of free sale, taking into \naccount internati onal practice as regards the use of certificates of free sale. Those implementing acts shall be adop ted in \naccordance with the advisor y procedure refer red to in Article 114(2). \nCHAPTER VI \nCLINIC AL EVALU ATION AND CLINIC AL INVESTIGA TIONS"
},
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Classification and conformity assessment"
}
|
{
"text": "CE MARKING OF CONFORMIT Y \n1. The CE marking shall consist of the initials ‘CE’ taking the following form: \n2. If the CE marking is reduced or enlarg ed, the propor tions given in the above graduat ed drawing shall be respected . \n3. The various components of the CE marking shall have substantially the same vertical dimension, whic h may not be \nless than 5 mm. This minimum dimension may be waived for small-scale devices. 5.5.2017 L 117/114 Official Jour nal of the European Union EN",
"title": "ANNEX V"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
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"Article 61": {
"heading": "Clinical evaluation",
"text": "Article 61 and Part A of this Annex and in the risk manag ement refer red to in Section 3 of Annex I. If, through \nthe PMCF , the need for preventive and/or corrective measures has been identified, the manuf acturer shall \nimp lement them. 5.5.2017 L 117/166 Official Jour nal of the European Union EN \n ANNEX XV \nCLINIC AL INVESTIGA TIONS \nCHAPTER I \nGENERAL REQUIREMENTS \n1. Ethical principles \nEach step in the clinical investigat ion, from the initial consideration of the need for and justification of the study \nto the publication of the results, shall be carried out in accordance with recognised ethical principles. \n2. Methods \n2.1. Clinical investigat ions shall be perf ormed on the basis of an appropr iate plan of inve stigation reflecting the \nlatest scientific and technical knowledge and defined in such a way as to conf irm or refute the manufacturer's \nclaims regarding the safety , performa nce and aspects relating to benefit-r isk of devices as refer red to in"
},
"Article 62": {
"heading": "General requirements regarding clinical investigations conducted to demonstrate conformity of devices",
"text": "Article 62(2) established in the Union. \n3.1.3. Information on the principal investigat or at each investigat ional site, the coordinating inve stigat or for the \ninve stigation, the address details for each investig ational site and the emergency contact details for the principal \ninve stigat or at each site. The roles, responsibilities and qualif ications of the various kinds of investigat ors shall \nbe specif ied in the CIP. 5.5.2017 L 117/169 Official Jour nal of the European Union EN \n 3.1.4. A brief descr iption of how the clinical inve stigation is financed and a brief descr iption of the agreement \nbetween the sponsor and the site. \n3.1.5. Overall synopsis of the clinical investiga tion, in an official Union language determined by the Member State \nconcer ned. \n3.2. Identif ication and descr iption of the device, including its intende d purpose, its manufacturer , its traceability , the \ntarget population, mater ials coming into contact with the human body , the medical or surgical procedures \ninvolved in its use and the necessar y training and exper ience for its use, back ground literature review , the \ncurrent state of the art in clinical care in the relevant field of application and the proposed benefi ts of the new \ndevice. \n3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding expect ed clinical \noutcomes in the clinical investigation plan. \n3.4. Descr iption of the relevance of the clinical investig ation in the cont ext of the state of the art of clinical practice. \n3.5. Objectives and hypotheses of the clinical inve stigation. \n3.6. Design of the clinical investigat ion with evidence of its scientifi c robustness and validity . \n3.6.1. General information such as type of investigat ion with rationale for choosing it, for its endpoints and for its \nvariables as set out in the clinical evaluation plan. \n3.6.2. Information on the investigational device, on any compar ator and on any other device or medication to be used \nin the clinical investig ation. \n3.6.3. Information on subjects, selection criteria, size of investigat ion population, representativeness of investig ation \npopulation in relation to targe t population and, if applicable, information on vulnerable subjects involved such \nas children, pregnant women, immuno-comprom ised or, elderly subjects. \n3.6.4. Details of measures to be take n to minimise bias, such as randomisation, and management of potential \nconf ounding factors. \n3.6.5. Descr iption of the clinical procedures and diagnostic methods relating to the clinical investig ation and in \nparticular highlighting any deviation from normal clinical practice. \n3.6.6. Monitoring plan. \n3.7. Statistical considerations, with justification, including a power calculation for the sample size, if applicable. \n3.8. Data manage ment. \n3.9. Information about any amendments to the CIP. \n3.10. Policy regar ding follow-up and management of any deviations from the CIP at the investigational site and clear \nprohibition of use of waivers from the CIP. \n3.11. Accountability regar ding the device, in particular control of access to the device, follow-up in relation to the \ndevice used in the clinical investig ation and the retur n of unused, expired or malfunctioning devices. \n3.12. State ment of compl iance with the recognised ethical principles for medical research involving humans, and the \nprinciples of good clinical practice in the field of clinical inve stigations of devices, as well as with the applicable \nregulatory requirements. \n3.13. Descr iption of the Informed consent process. \n3.14. Safety repor ting, including definit ions of adverse events and serious adverse events, device deficiencies, \nprocedures and timelines for repor ting. 5.5.2017 L 117/170 Official Jour nal of the European Union EN \n 3.15. Criteria and procedures for follow-up of subjects following the end, temporar y halt or early term ination of an \ninve stigation, for follow-up of subjects who have withdrawn their consent and procedures for subjects lost to \nfollow-up. Such procedures shall for implantable devices, cover as a minimum traceability . \n3.16. A descr iption of the arrang ements for taking care of the subjects after their participation in the clinical investi \ngation has ended, where such additional care is necessar y because of the subjects' participation in the clinical \ninve stigation and where it differ s from that normally expect ed for the medical condition in question. \n3.17. Policy as regards the establishment of the clinical investigation repor t and publication of results in accordance \nwith the legal requirements and the ethical principles refer red to in Section 1 of Chapt er I. \n3.18. List of the technical and functional features of the device, with specifi c mention of those covered by the inve sti\ngation. \n3.19. Bibliography . \n4. Other information \n4.1. A signed state ment by the natural or legal person responsible for the manufa cture of the investig ational device \nthat the device in question conf orms to the general safety and performa nce requirements apar t from the aspects \ncovered by the clinical investigat ion and that, with regar d to those aspects, ever y precaution has been taken to \nprotect the health and safety of the subject. \n4.2. Where applicable according to national law, copy of the opinion or opinions of the ethics committee or \ncommittees concer ned. Where according to national law the opinion or opinions of the ethics committee or \ncommittees is not required at the time of the submission of the application, a copy of the opinion or opinions \nshall be submitted as soon as available. \n4.3. Proof of insurance cover or indemnifi cation of subjects in case of injur y, pursuant to Article 69 and the \ncorresponding national law. \n4.4. Documents to be used to obtain informed consent, including the patient information sheet and the informed \nconsent document. \n4.5. Descr iption of the arrange ments to compl y with the applicable rules on the prote ction and conf identiality of \npersonal data, in particular: \n— organisational and technical arrange ments that will be imp lemented to avoid unauthor ised access, disclosure, \ndissemination, alteration or loss of information and personal data processed; \n— a descr iption of measures that will be imple mented to ensure confidentiality of records and personal data of \nsubjects; and \n— a descr iption of measures that will be imple mented in case of a data secur ity breac h in order to mitig ate the \npossible adverse effects. \n4.6. Full details of the available technical documentation, for example detailed risk analysis/manag ement documen \ntation or specifi c test repor ts, shall, upon request, be submitte d to the compet ent author ity reviewing an \napplication. \nCHAPTER III \nOTHER OBLIGA TIONS OF THE SPONSOR \n1. The sponsor shall under take to keep available for the compet ent national author ities any documentation \nnecessar y to provide evidence for the documentation refer red to in Chapt er II of this Annex. If the sponsor is \nnot the natural or legal person responsible for the manuf acture of the investig ational device, that oblig ation may \nbe fulfilled by that person on behalf of the sponsor . 5.5.2017 L 117/171 Official Jour nal of the European Union EN \n 2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as \nrefer red to in Article 80(2) are repor ted by the investig ator or investigat ors to the sponsor in a timely manner . \n3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical \ninve stigation with the device in question has ended, or, in the event that the device is subsequently placed on \nthe market, at least 10 years after the last device has been placed on the mark et. In the case of implantable \ndevices, the period shall be at least 15 years. \nEach Member State shall require that this documentation is kept at the disposal of the compet ent author ities for \nthe period referred to in the first subparagraph in case the sponsor , or its contact person or legal representative \nas referred to in Article 62(2) established within its territory, goes bankr upt or ceases its activity prior to the \nend of this period. \n4. The Sponsor shall appoint a monitor that is independent from the investigat ional site to ensure that the investi \ngation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation. \n5. The Sponsor shall compl ete the follow-up of inve stigation subjects. \n6. The Sponsor shall provide evidence that the investigation is being conduct ed in line with good clinical practice, \nfor instance through internal or external inspection. \n7. The Sponsor shall prepare a clinical investig ation repor t whic h includes at least the following: \n— Cover/introduct ory page or pages indicating the title of the investigation, the investig ational device, the \nsing le identif ication number , the CIP number and the details with signatures of the coordinating investigat ors \nand the principal investigat ors from each investig ational site. \n— Details of the author and date of the repor t. \n—A summar y of the investigat ion covering the title, purpose of the investig ation, descr iption of the investi\ngation, inve stigational design and methods used, the results of the inve stigation and conclusion of the \ninvestigation. The compl etion date of the investigation, and in particular details of early termination, \ntemporar y halts or suspensions of investig ations. \n— Investigational device descr iption, in particular clearly defined intended purpose. \n— A summar y of the clinical investigat ion plan covering objectives, design, ethical aspects, monitori ng and \nquality measures, selection criteria, target patient populations, sample size, treatment schedules, follow-up \nduration, concomitant treatments, statistical plan, including hypothesis, sample size calculation and analysis \nmethods, as well as a justification. \n— Results of the clinical investig ation covering, with rationale and justif ication, subject demographics, analysis \nof results related to chosen endpoints, details of subgroup analysis, as well as compl iance with the CIP, and \ncovering follow-up of missing data and of patients withdrawing from the clinical investigation, or lost to \nfollow-up. \n— Summar y of serious adverse events, adverse device effects, device deficiencies and any relevant corrective \nactions. \n— Discussion and overall conclusions covering safety and performa nce results, assessment of risks and clinical \nbenefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions \nfor specifi c patient populations, implications for the investigational device, limitations of the investigation. 5.5.2017 L 117/172 Official Jour nal of the European Union EN \n ANNEX XVI \nLIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDIC AL PURPOSE REFERRED TO IN \nART ICLE 1(2) \n1. Contact lenses or other items intended to be introduced into or onto the eye. \n2. Products intende d to be tota lly or partially introduced into the human body through surgically invasive means for \nthe purpose of modifying the anat omy or fixation of body parts with the excep tion of tattooing products and \npiercings. \n3. Substances, combinations of substances, or items intende d to be used for facial or other dermal or mucous \nmembrane filling by subcutaneous, submucous or intrader mal injection or other introduction, excl uding those for \ntattooing. \n4. Equipment intended to be used to reduce, remo ve or destro y adipose tissue, such as equipment for liposuction, \nlipolysis or lipoplasty . \n5. High intensi ty electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for \nuse on the human body , including coherent and non-coherent sources, monoc hromatic and broad spectr um, such as \nlasers and intense pulsed light equipment, for skin resur facing, tattoo or hair remo val or other skin treatment. \n6. Equipment intended for brain stimulation that apply electr ical currents or magnetic or electromagnetic fields that \npenetrat e the cranium to modify neuronal activity in the brain. 5.5.2017 L 117/173 Official Jour nal of the European Union EN \n ANNEX XVII \nCORREL ATION TABLE \nCouncil Directive 90/385/EEC Council Directive 93/42/EEC This Regulation"
},
"Article 63": {
"heading": "Informed consent",
"text": "Article 63(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by \nthe inve stigat or; \n(d) no incentives or financial inducements are given to the subject or his or her legally designate d representative excep t \nfor compen sation for expenses and loss of earnings directly relat ed to the participation in the clinical inve stigation; \n(e) the clinical investigation is intende d to inve stigat e treatments for a medical condition that only occurs in minors or \nthe clinical investig ation is essential with respect to minors to validat e data obtained in clinical investigations on \npersons able to give informed consent or by other research methods; \n(f) the clinical investigation either relat es directly to a medical condition from which the minor concer ned suffe rs or is \nof such a nature that it can only be carried out on minors; \n(g) there are scientifi c grounds for expecting that participation in the clinical investigation will produce a direct benefit \nto the minor subject outweighing the risks and burdens involved; \n(h) the minor shall take part in the informed consent procedure in a way adap ted to his or her age and mental matur ity; \n(i) if during a clinical investig ation the minor reac hes the age of lega l compet ence to give informed consent as defined \nin national law, his or her express informed consent shall be obtained before that subject can continue to participate \nin the clinical investig ation."
},
"Article 64": {
"heading": "Clinical investigations on incapacitated subjects",
"text": "Article 64 \nClinical investigations on incapacitated subjects \n1. In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the \nonset of their incapacity , a clinical investigation may be conducted only where, in addition to the conditions set out in"
},
"Article 65": {
"heading": "Clinical investigations on minors",
"text": "Article 65 \nClinical investigations on minors \nA clinical investiga tion on minors may be conduct ed only where, in addition to the conditions set out in Article 62(4), \nall of the following conditions are met: \n(a) the informed consent of their legally designate d representative has been obtained; 5.5.2017 L 117/60 Official Jour nal of the European Union EN \n (b) the minors have received the information referred to in Article 63(2) in a way adapt ed to their age and mental \nmatur ity and from investigat ors or members of the investig ating team who are trained or exper ienced in working \nwith children; \n(c) the explicit wish of a minor who is capable of forming an opinion and assessing the information refer red to in"
},
"Article 66": {
"heading": "Clinical investigations on pregnant or breastfeeding women",
"text": "Article 66 \nClinical investigations on pregnant or breast feeding women \nA clinical investigat ion on pregnant or breastf eeding women may be conducted only where, in addition to the \nconditions set out in Article 62(4), all of the following conditions are met: \n(a) the clinical investig ation has the potential to produce a direct benefit for the pregnant or breastf eeding woman \nconcer ned, or her embr yo, foetus or child after birth, outweighing the risks and burdens involved; \n(b) where research is under take n on breastfeeding women, particular care is taken to avoid any adverse impa ct on the \nhealth of the child; \n(c) no incentives or financial inducements are given to the subject excep t for compen sation for expenses and loss of \nearnings directly relat ed to the participation in the clinical inve stigation."
},
"Article 67": {
"heading": "Additional national measures",
"text": "Article 67 \nAdditional national measures \nMember State s may maintain additional measures regar ding persons performin g mandatory militar y service, persons \ndepr ived of liber ty, persons who, due to a judicial decision, cannot take part in clinical investigations, or persons in \nresidential care institutions."
},
"Article 68": {
"heading": "Clinical investigations in emergency situations",
"text": "Article 68 \nClinical investigations in emergency situations \n1. By way of deroga tion from point (f) of Article 62(4), from points (a) and (b) of Article 64(1) and from points (a) \nand (b) of Article 65, informed consent to participate in a clinical investigation may be obtained, and information on \nthe clinical investigat ion may be given, after the decision to include the subject in the clinical investig ation, provided that \nthat decision is take n at the time of the first intervention on the subject, in accordance with the clinical inve stigation \nplan for that clinical inve stigation and that all of the following conditions are fulfilled: \n(a) due to the urgency of the situation, caused by a sudden life-threat ening or other sudden serious medical condition, \nthe subject is unable to provide prior informed consent and to receive prior information on the clinical investi\ngation; 5.5.2017 L 117/61 Official Jour nal of the European Union EN \n (b) there are scientific grounds to expect that participation of the subject in the clinical investigation will have the \npoten tial to produce a direct clinically relevant benefit for the subject resulting in a measurable health-relate d \nimp rovement alleviating the suffe ring and/or impro ving the health of the subject, or in the diagnosis of its \ncondition; \n(c) it is not possible within the therapeutic windo w to supply all prior information to and obtain prior informed \nconsent from his or her legally designat ed representative; \n(d) the inve stigat or certifies that he or she is not aware of any objections to participate in the clinical inve stigation \npreviously expressed by the subject ; \n(e) the clinical investig ation relat es directly to the subject's medical condition because of whic h it is not possible within \nthe therapeutic windo w to obtain prior informed consent from the subject or from his or her legally designat ed rep\nresentative and to supply prior information, and the clinical investigat ion is of such a nature that it may be \nconduct ed excl usively in emergency situations; \n(f) the clinical inve stigation poses a minimal risk to, and imposes a minimal burden on, the subject in compari son with \nthe standard treatment of the subject's condition. \n2. Follo wing an intervention pursuant to paragraph 1 of this Article, informed consent in accordance with Article 63 \nshall be sought to continue the participation of the subject in the clinical investiga tion, and information on the clinical \ninvestigation shall be given, in accordance with the following requirements: \n(a) regarding incapacitate d subjects and minors, the informed consent shall be sought by the investiga tor from his or \nher legally designat ed representative without undue dela y and the information refer red to in Article 63(2) shall be \ngiven as soon as possible to the subject and to his or her legally designat ed representative; \n(b) regarding other subjects, the informed consent shall be sought by the investig ator without undue dela y from the \nsubject or his or her lega lly designate d representative, whichever can be done sooner , and the information refer red to \nin Article 63(2) shall be given as soon as possible to the subject or his or her legally designate d representative, as \napplicable. \nFor the purposes of point (b) where informed consent has been obtained from the legally designat ed representative, \ninformed consent to continue the participation in the clinical investiga tion shall be obtained from the subject as soon as \nhe or she is capable of giving informed consent. \n3. If the subject or, where applicable, his or her lega lly designate d representative does not give consent, he or she \nshall be informed of the right to object to the use of data obtained from the clinical investig ation."
},
"Article 69": {
"heading": "Damage compensation",
"text": "Article 69 \nDamage compensation \n1. Member States shall ensure that systems for compensation for any damage suffered by a subject resulting from par\nticipation in a clinical investig ation conducted on their territory are in place in the form of insurance, a guarantee, or \na similar arrange ment that is equivalent as regards its purpose and which is appropr iate to the nature and the extent of \nthe risk. \n2. The sponsor and the investig ator shall mak e use of the syste m referred to in paragraph 1 in the form appropr iate \nfor the Member State in which the clinical investigation is conduct ed."
},
"Article 7": null,
"Article 70": {
"heading": "Application for clinical investigations",
"text": "Article 70 \nApplication for clinical investigations \n1. The sponsor of a clinical inve stigation shall submit an application to the Member State(s) in which the clinical \ninvestigation is to be conduct ed (referr ed to for the purposes of this Article as ‘Member State concer ned’) accompanied \nby the documentation refer red to in Chapt er II of Annex XV. \nThe application shall be submitted by means of the electronic system referred to in Article 73, whic h shall generate \na Union-wide unique sing le identif ication number for the clinical investigation, whic h shall be used for all relevant \ncommunication in relation to that clinical inve stigation. Within 10 days of it receiving the application, the Member State \nconcer ned shall notify the sponsor as to whether the clinical investigation falls within the scope of this Regulation and \nas to whether the application dossier is compl ete in accordance with Chapt er II of Annex XV. 5.5.2017 L 117/62 Official Jour nal of the European Union EN \n 2. Within one week of any change occur ring in relation to the documentation refer red to in Chapt er II of Annex XV, \nthe sponsor shall updat e the relevant data in the electronic system refer red to in Article 73 and mak e that change to the \ndocumentation clearly identifiable. The Member State concer ned shall be notifi ed of the update by means of that \nelectronic system. \n3. Where the Member State concer ned finds that the clinical inve stigation applied for does not fall within the scope \nof this Regulation or that the application dossier is not complet e, it shall inform the sponsor thereof and shall set a time \nlimit of maximum 10 days for the sponsor to comment or to compl ete the application by means of the electronic \nsystem refer red to in Article 73. The Member State concer ned may extend this period by a maximum of 20 days where \nappropr iate. \nWhere the sponsor has not provided comments nor compl eted the application within the time limit refer red to in the \nfirst subparagraph, the application shall be deemed to have lapsed. Where the sponsor considers the application does fall \nunder the scope of this Regulation and/or is compl ete but the Member State concer ned does not, the application shall \nbe considered to have been reject ed. The Member State concer ned shall provide for an appeal procedure in respect of \nsuch refusal. \nThe Member State concer ned shall notify the sponsor within five days of receipt of the comments or of the request ed \nadditional information, whether the clinical investigation is considered as falling within the scope of this Regulation and \nthe application is compl ete. \n4. The Member State concer ned may also extend the period referred to in paragraph 1 and 3 each by a further \nfive days. \n5. For the purposes of this Chapt er, the date on which the sponsor is notifi ed in accordance with paragraph 1 or 3 \nshall be the validation date of the application. Where the sponsor is not notifi ed, the validation date shall be the last day \nof the periods refer red to in paragraphs 1, 3 and 4 respectively . \n6. Dur ing the period when the application is being assessed, the Member State may request additional information \nfrom the sponsor . The expir y of the period laid down in point (b) of paragraph 7 shall be suspended from the date of \nthe first request until such time as the additional information has been received. \n7. The sponsor may start the clinical investig ation in the following circumstances: \n(a) in the case of investigational class I devices or in the case of non-in vasive class IIa and class IIb devices, unless \nother wise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, \nand provided that a negative opinion whic h is valid for the entire Member State, under national law, has not been \nissued by an ethics committee in the Member State concer ned in respect of the clinical inve stigation; \n(b) in the case of investig ational devices, other than those refer red to in point (a), as soon as the Member State \nconcer ned has notifi ed the sponsor of its author isation, and provided that a negative opinion which is valid for the \nentire Member State, under national law, has not been issued by an ethics committee in the Member State concer ned \nin respect of the clinical inve stigation. The Member State shall notify the sponsor of the author isation within \n45 days of the validation date referred to in paragraph 5. The Member State may exte nd this period by a further \n20 days for the purpose of consulting with exper ts. \n8. The Commission is empo wered to adopt delegat ed acts in accordance with Article 115 amending, in the light of \ntechnical progress and global regulatory developments, the requirements laid down in Chapt er II of Annex XV. \n9. In order to ensure the unif orm application of the requirements laid down in Chapt er II of Annex XV, the \nCommission may adopt imple menting acts to the exte nt necessar y to resolve issues of divergent interpretation and of \npractical application. Those implementing acts shall be adopt ed in accordance with the examination procedure refer red \nto in Article 114(3)."
},
"Article 71": {
"heading": "Assessment by Member States",
"text": "Article 71 \nAssessment by Member States \n1. Member State s shall ensure that the persons validating and assessing the application, or deciding on it, do not have \nconf licts of interest, are independent of the sponsor , the investigat ors involved and of natural or legal persons financing \nthe clinical investigat ion, as well as free of any other undue influence. 5.5.2017 L 117/63 Official Jour nal of the European Union EN \n 2. Member States shall ensure that the assessment is done jointly by an appropr iate number of persons who \ncollectively have the necessar y qualifications and exper ience. \n3. Member States shall assess whether the clinical investig ation is designed in such a way that poten tial remaining \nrisks to subjects or third persons, after risk minimization, are justif ied, when weighed against the clinical benefits to be \nexpecte d. They shall, while taking into account applicable CS or harmonised standards, examine in particular: \n(a) the demonstration of compl iance of the inve stigational device(s) with the applicable general safety and performance \nrequirements, apar t from the aspects covered by the clinical investigation, and whether , with rega rd to those aspects, \never y precaution has been taken to prot ect the health and safety of the subjects. This includes, where appropr iate, \nassurance of technical and biological safety testing and pre-clinical evaluation; \n(b) whether the risk-minimisation solutions emplo yed by the sponsor are descr ibed in harmonised standards and, in \nthose cases where the sponsor does not use harmonised standards, whether the risk-minimisation solutions provide \na level of prote ction that is equivalent to that provided by harmonised standards; \n(c) whether the measures planned for the safe installation, putting into service and mainte nance of the investigational \ndevice are adequate ; \n(d) the reliability and robustness of the data generat ed in the clinical inve stigation, taking account of statistical \napproaches, design of the investigation and methodological aspects, including sample size, compar ator and \nendpoints; \n(e) whether the requirements of Annex XV are met ; \n(f) in the case of devices for steri le use, evidence of the validation of the manuf acturer's sterilisation procedures or \ninformation on the reconditioning and sterilisation procedures which have to be conduct ed by the investigat ion site; \n(g) the demonstration of the safety , quality and usefulness of any components of animal or human origin or of \nsubstances, whic h may be considered medicinal products in accordance with Directive 2001/83/EC. \n4. Member States shall refuse the author isation of the clinical investigation if: \n(a) the application dossier submitted pursuant to Article 70(1) remains incomplet e; \n(b) the device or the submitt ed documents, especially the investig ation plan and the investigat or's broc hure, do not \ncorrespond to the state of scientific kno wledge, and the clinical inve stigation, in particular , is not suitable for \nproviding evidence for the safet y, performance charact eristics or benefit of the device on subjects or patients, \n(c) the requirements of Article 62 are not met, or \n(d) any assessment under paragraph 3 is negat ive. \nMember States shall provide for an appeal procedure in respect of a refusal pursuant to the first subparagraph."
},
"Article 72": {
"heading": "Conduct of a clinical investigation",
"text": "Article 72 \nConduct of a clinical investigation \n1. The sponsor and the inve stigat or shall ensure that the clinical investigation is conduct ed in accordance with the \nappro ved clinical investigation plan. \n2. In order to verify that the rights, safety and well-being of subjects are prote cted, that the repor ted data are reliable \nand robust, and that the conduct of the clinical inve stigation is in compl iance with the requirements of this Regulation, \nthe sponsor shall ensure adequate monitori ng of the conduct of a clinical investig ation. The extent and nature of the \nmonitoring shall be deter mined by the sponsor on the basis of an assessment that takes into consideration all charact er\nistics of the clinical investiga tion including the following: \n(a) the objective and methodology of the clinical investigation; and \n(b) the degree of deviation of the intervention from normal clinical practice. 5.5.2017 L 117/64 Official Jour nal of the European Union EN \n 3. All clinical investig ation information shall be recorded, processed, handled, and stored by the sponsor or \ninvestigat or, as applicable, in such a way that it can be accurately repor ted, interpr eted and verified while the conf iden \ntiality of records and the personal data of the subjects remain prot ected in accordance with the applicable law on \npersonal data protection. \n4. Appropr iate technical and organisational measures shall be implement ed to prot ect information and personal data \nprocessed against unauthor ised or unlawful access, disclosure, dissemination, alteration, or destr uction or accidental loss, \nin particular where the processing involves transmission over a network. \n5. Member States shall inspect, at an appropr iate level, investigat ion site(s) to check that clinical investigations are \nconduct ed in accordance with the requirements of this Regulation and with the appro ved inve stigation plan. \n6. The sponsor shall establish a procedure for emergency situations which enables the immediate identification and, \nwhere necessar y, an immediate recall of the devices used in the investig ation."
},
"Article 73": {
"heading": "Electronic system on clinical investigations",
"text": "Article 73. The sponsor shall include the documentation referred to in Chapt er II of Annex XV as part of the \nnotificati on. Points (b) to (k) and (m) of Article 62(4), Article 75, Article 76, Article 77, Article 80(5) and the relevant \nprovisions of Annex XV shall apply to PMCF inve stigations. \n2. Where a clinical investig ation is to be conducted to assess, outside the scope of its intended purpose, a device \nwhic h already bears the CE marking in accordance with Article 20(1), Articles 62 to 81 shall apply ."
},
"Article 74": {
"heading": "Clinical investigations regarding devices bearing the CE marking",
"text": "Article 74 \nClinical investigations regarding devices bear ing the CE marking \n1. Where a clinical inve stigation is to be conducted to further assess, within the scope of its intended purpose, \na device which already bears the CE marking in accordance with Article 20(1), (‘PMCF investigation’), and where the \ninvestigation would involve submitting subjects to procedures additional to those performed under the normal \nconditions of use of the device and those additional procedures are invasive or burdensome, the sponsor shall notify the \nMember States concer ned at least 30 days prior to its commencement by means of the electronic system referred to in"
},
"Article 75": {
"heading": "Substantial modifications to clinical investigations",
"text": "Article 75 \nSubst antial modif ications to clinical investigat ions \n1. If a sponsor intends to introduce modif ications to a clinical investig ation that are likely to have a substantial \nimpact on the safety , health or rights of the subjects or on the robustness or reliability of the clinical data generate d by \nthe investigat ion, it shall notify , within one week, by means of the electronic system referred to in Article 73 the \nMember State(s) in which the clinical inve stigation is being or is to be conduct ed of the reasons for and the nature of \nthose modifi cations. The sponsor shall include an update d version of the relevant documentation referred to in \nChapt er II of Annex XV as part of the notifi cation. Changes to the relevant documentation shall be clearly identif iable. \n2. The Member State shall assess any substantial modifi cation to the clinical investigation in accordance with the \nprocedure laid down in Article 71. \n3. The sponsor may implement the modifications refer red to in paragraph 1 at the earliest 38 days after the \nnotificati on referred to in that paragraph, unless: \n(a) the Member State in whic h the clinical investig ation is being or is to be conducted has notified the sponsor of its \nrefusal based on the grounds refer red to in Article 71(4) or on considerations of public health, subject and user \nsafety or health, of public policy , or \n(b) an ethics committee in that Member State has issued a negative opinion in relation to the substantial modific ation to \nthe clinical investigation, which , in accordance with national law, is valid for that entire Member State . \n4. The Member State (s) concer ned may exte nd the period referred to in paragraph 3 by a further seven days, for the \npurpose of consulting with exper ts."
},
"Article 76": {
"heading": "Corrective measures to be taken by Member States and information exchange between Member States",
"text": "Article 76 \nCor rectiv e measures to be taken by Member States and informa tion exchange betw een \nMember States \n1. Where a Member State in whic h a clinical investig ation is being or is to be conducted has grounds for consider ing \nthat the requirements set out in this Regulation are not met, it may take at least any of the following measures on its \nterritory : \n(a) revok e the author isation for the clinical investigat ion; \n(b) suspend or term inate the clinical investigation; \n(c) require the sponsor to modify any aspect of the clinical investig ation. \n2. Before the Member State concer ned takes any of the measures referred to in paragraph 1 it shall, excep t where \nimmediate action is required, ask the sponsor or the investig ator or both for their opinion. That opinion shall be \ndelivered within seven days. 5.5.2017 L 117/66 Official Jour nal of the European Union EN \n 3. Where a Member State has taken a measure refer red to in paragraph 1 of this Article or has refused a clinical \ninvestigation, or has been notifi ed by the sponsor of the early term ination of a clinical investigat ion on safety grounds, \nthat Member State shall communicat e the corresponding decision and the grounds theref or to all Member State s and the \nCommission by means of the electronic system referred to in Article 73. \n4. Where an application is withdra wn by the sponsor prior to a decision by a Member State , that information shall \nbe made available through the electronic system refer red to in Article 73 to all Member States and the Commission."
},
"Article 77": {
"heading": "Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination",
"text": "Article 77 \nInforma tion from the sponsor at the end of a clinical investigation or in the event of a temporar y \nhalt or early termination \n1. If the sponsor has temporar ily halted a clinical investigat ion or has term inate d a clinical investigation early , it shall \ninform within 15 days the Member State in which that clinical inve stigation has been temporar ily halte d or terminated \nearly , through the electronic system referred to in Article 73, of the temporar y halt or early termination, providing \na justification. In the event that the sponsor has temporar ily halted or terminated early the clinical inve stigation on \nsafety grounds, it shall inform all Member States in whic h that clinical investigat ion is being conducted thereof within \n24 hours. \n2. The end of a clinical inve stigation shall be deemed to coincide with the last visit of the last subject unless another \npoint in time for such end is set out in the clinical investigation plan. \n3. The sponsor shall notify each Member State in which a clinical investig ation was being conducted of the end of \nthat clinical investigation in that Member State. That notifi cation shall be made within 15 days of the end of the clinical \ninvestigation in relation to that Member State. \n4. If an investigation is conduct ed in more than one Member State , the sponsor shall notify all Member States in \nwhic h that clinical investiga tion was conduct ed of the end of the clinical investigation in all Member States. That \nnotificati on shall be made within 15 days of that end of the clinical investigat ion. \n5. Irrespective of the outcome of the clinical investig ation, within one year of the end of the clinical investig ation or \nwithin three months of the early term ination or temporar y halt, the sponsor shall submit to the Member States in whic h \na clinical investig ation was conducted a clinical inve stigation repor t as refer red to in Section 2.8 of Chapt er I and \nSection 7 of Chapt er III of Annex XV. \nThe clinical investig ation repor t shall be accompanied by a summar y presented in term s that are easily understandable \nto the intended user . Both the repor t and summar y shall be submitted by the sponsor by means of the electronic system \nreferred to in Article 73. \nWhere, for scientific reasons, it is not possible to submit the clinical investigation repor t within one year of the end of \nthe inve stigation, it shall be submitted as soon as it is available. In such case, the clinical investig ation plan refer red to in \nSection 3 of Chapt er II of Annex XV shall specify when the results of the clinical inve stigation are going to be available, \ntogether with a justif ication. \n6. The Commission shall issue guidelines regar ding the conte nt and structure of the summar y of the clinical investi \ngation repor t. \nIn addition, the Commission may issue guidelines for the formatting and shar ing of raw data, for cases where the \nsponsor decides to share raw data on a volun tary basis. Those guidelines may take as a basis and adap t, where possible, \nexisting guidelines for shar ing of raw data in the field of clinical investigations. \n7. The summar y and the clinical inve stigation repor t referred to in paragraph 5 of this Article shall become publicly \naccessible through the electronic system referred to in Article 73, at the latest when the device is register ed in \naccordance with Article 29 and before it is placed on the market. In cases of early term ination or temporar y halt, the \nsummar y and the repor t shall become publicly accessible immediately after submission. \nIf the device is not registere d in accordance with Article 29 within one year of the summar y and the repor t having been \nentered into the electronic system pursuant to paragraph 5 of this Article, they shall become publicly accessible at that \npoint in time. 5.5.2017 L 117/67 Official Jour nal of the European Union EN"
},
"Article 78": {
"heading": "Coordinated assessment procedure for clinical investigations",
"text": "Article 78, the sponsor shall repor t any event as refer red to in paragraph 2 of this Article by means of the electronic \nsystem refer red to in Article 73. Upon receipt, this repor t shall be transmitte d electronically to all Member States in \nwhic h the clinical investigat ion is being conducted. \nUnder the direction of the coordinating Member State refer red to in Article 78(2), the Member State s shall coordinat e \ntheir assessment of serious adverse events and device deficiencies to deter mine whether to modify , suspend or terminate \nthe clinical investigat ion or whether to revok e the author isation for that clinical investigation. \nThis paragraph shall not affect the rights of the other Member State s to perform their own evaluation and to adopt \nmeasures in accordance with this Regulation in order to ensure the protection of public health and patient safety . The \ncoordinating Member State and the Commission shall be kept informed of the outcome of any such evaluation and the \nadoptio n of any such measures. \n5. In the case of PMCF investigations refer red to in Article 74(1), the provisions on vigilance laid down in Articles 87 \nto 90 and in the acts adopt ed pursuant to Article 91 shall apply instead of this Article. \n6. Notwithstanding paragraph 5, this Article shall apply where a causal relationship between the serious adverse \nevent and the preceding investiga tional procedure has been established."
},
"Article 79": {
"heading": "Review of coordinated assessment procedure",
"text": "Article 79 \nReview of coordinated assessment procedure \nBy 27 May 2026, the Commission shall submit to the European Parliament and to the Council a repor t on exper ience \ngained from the application of Article 78 and, if necessar y, propose a review of Article 78(14) and point (h) of"
},
"Article 8": null,
"Article 80": {
"heading": "Recording and reporting of adverse events that occur during clinical investigations",
"text": "Article 80; \n(f) the timelines for the repor ting of serious adverse events and device deficiencies, taking into account the sever ity of \nthe event to be repor ted as refer red to in Article 80; \n(g) unif orm application of the requirements regarding the clinical evidence or data needed to demonstrate compl iance \nwith the general safety and performance requirements set out in Annex I. \nThe imple menting acts refer red to in the first paragraph shall be adopt ed in accordance with the examination procedure \nreferred to in Article 114(3)."
},
"Article 81": {
"heading": "Implementing acts",
"text": "Article 81 \nImplementing acts \nThe Commission may, by means of imple menting acts, establish the detailed arrangements and procedural aspects \nnecessar y for the implementation of this Chapt er as regards the following: \n(a) harmonised electronic forms for the application for clinical investig ations and their assessment as referred to in \nArticles 70 and 78, taking into account specifi c categor ies or groups of devices; \n(b) the functioning of the electronic system refer red to in Article 73; \n(c) harmonised electronic forms for the notific ation of PMCF inve stigations as referred to in Article 74(1), and of \nsubstantial modific ations as refer red to in Article 75; \n(d) the exchang e of information between Member States as refer red to in Article 76; 5.5.2017 L 117/70 Official Jour nal of the European Union EN \n (e) harmonised electronic forms for the repor ting of serious adverse events and device deficiencies as refer red to in"
},
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Clinical evaluation and clinical investigations"
}
|
{
"text": "INFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS IN ACCORD ANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED \nTO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORD ANCE WITH ART ICLES 28 AND 29, \nAND THE UDI SYSTEM \nPART A \nINFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS IN ACCORD ANCE WITH ARTICLES 29(4) AND 31 \nManufactur ers or, when applicable, author ised representatives, and, when applicable, impor ters shall submit the \ninformation refer red to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is \ncompl ete, correct and updated by the relevant party. \n1. Information relating to the economic operat or \n1.1. type of economic operat or(manuf acturer , author ised representative, or impor ter), \n1.2. name, address and contact details of the economic operat or, \n1.3. where submission of information is carried out by another person on behalf of any of the economic operat ors \nmentioned under Section 1.1, the name, address and contact details of that person, \n1.4. name address and contact details of the person or persons responsible for regulatory compl iance refer red to in \nArticle 15. \n2. Information relating to the device \n2.1. Basic UDI-DI, \n2.2. type, number and expir y date of the certificate issued by the notifi ed body and the name or identif ication \nnumber of that notified body and the link to the information that appears on the certificate and was entered by \nthe notified body in the electronic system on notified bodies and certificates, \n2.3. Member State in which the device is to or has been placed on the mark et in the Union, \n2.4. in the case of class IIa, class IIb or class III devices: Member State s where the device is or is to be made available, \n2.5. risk class of the device, \n2.6. reprocessed sing le-use device (y/n), \n2.7. presence of a substance which , if used separately , may be considered to be a medicinal product and name of that \nsubstance, \n2.8. presence of a substance whic h, if used separately , may be considered to be a medicinal product derived from \nhuman blood or human plasma and name of this substance, \n2.9. presence of tissues or cells of human origin, or their derivatives (y/n), \n2.10. presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 \n(y/n), \n2.11. where applicable, the sing le identif ication number of the clinical investigation or investigat ions conduct ed in \nrelation to the device or a link to the clinical investig ation registration in the electronic system on clinical inve sti\ngations, \n2.12. in the case of devices liste d in Annex XVI, specification as to whether the intended purpose of the device is \nother than a medical purpose, \n2.13. in the case of devices designed and manufactured by another legal or natural person as referred in \nArticle 10(15), the name, address and contact details of that legal or natural person, 5.5.2017 L 117/115 Official Jour nal of the European Union EN \n 2.14. in the case of class III or implantable devices, the summar y of safety and clinical performa nce, \n2.15. status of the device (on the mark et, no long er placed on the market, recalled, field safety corrective action \ninitiate d). \nPART B \nCORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN \nACCORD ANCE WITH ARTICLES 28 AND 29 \nThe manufact urer shall provide to the UDI database the UDI-DI and all of the following information relating to the \nmanufa cturer and the device: \n1. quantity per packag e configuration, \n2. the Basic UDI-DI as refer red to in Article 29 and any additional UDI-DIs, \n3. the manner in whic h production of the device is controlled (expir y date or manufa ctur ing date, lot number , serial \nnumber), \n4. if applicable, the unit of use UDI-DI (where a UDI is not labelled on the device at the level of its unit of use, a ‘unit \nof use’ DI shall be assigned so as to associate the use of a device with a patient), \n5. name and address of the manufacturer (as indicated on the label), \n6. the SRN issued in accordance with Article 31(2), \n7. if applicable, name and address of the author ised representative (as indicated on the label), \n8. the medical device nomenclature code as provided for in Article 26, \n9. risk class of the device, \n10. if applicable, name or trade name, \n11. if applicable, device model, referen ce, or catalogue number , \n12. if applicable, clinical size (including volume, length, gaug e, diamete r), \n13. additional product descr iption (optional), \n14. if applicable, storag e and/or handling conditions (as indicated on the label or in the instr uctions for use), \n15. if applicable, additional trade names of the device, \n16. labelled as a sing le-use device (y/n), \n17. if applicable, the maximum number of reuses, \n18. device labelled sterile (y/n), \n19. need for steri lisation before use (y/n), \n20. containing latex (y/n), \n21. where applicable, information labelled in accordance with Section 10.4.5 of Annex I, \n22. URL for additional information, such as electronic instr uctions for use (optional), \n23. if applicable, critical warnings or contra-indications, \n24. status of the device (on the market, no long er placed on the mark et, recalled, field safety corrective action initiated). 5.5.2017 L 117/116 Official Jour nal of the European Union EN \n PART C \nTHE UDI SYSTEM \n1. Defi nitions \nAutomatic identification and data capture (‘AIDC’) \nAIDC is a technology used to automa tically capture data. AIDC technologies include bar codes, smar t cards, \nbiometr ics and RFID. \nBasic UDI-DI \nThe Basic UDI-DI is the primar y identif ier of a device model. It is the DI assigned at the level of the device unit \nof use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU \ndeclarations of conf ormity . \nUnit of Use DI \nThe Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not \nlabelled on the individual device at the level of its unit of use, for example in the event of several units of the \nsame device being packa ged together . \nConfigurable device \nA conf igurable device is a device that consists of several compo nents whic h can be assembled by the \nmanufa cturer in multiple conf igurations. Those individual components may be devices in themselves. \nConfigurable devices include comput ed tomograph y (CT) syste ms, ultrasound systems, anaesthesia system s, \nphysiological Monitoring systems, radiology information system s (RIS). \nConfigurati on \nConfigurati on is a combination of items of equipment, as specified by the manuf acturer , that operat e together as \na device to achi eve an intended purpose. The combination of items may be modif ied, adjusted or customi zed to \nmeet specific needs. \nConfigurati ons include inter alia: \n— gantr ies, tubes, tables, consoles and other items of equipment that can be conf igured/combined to deliver an \nintended function in comput ed tomograph y. \n— ventilator s, breathing circuits, vapor izers combined to deliver an intended function in anaesthesia. \nUDI-DI \nThe UDI-DI is a unique numer ic or alphanumer ic code specific to a model of device and that is also used as the \n‘access key’ to information store d in a UDI database. \nHuman Readable Interp retation (‘HRI’) \nHRI is a legible interpretation of the data characters encoded in the UDI carrier. \nPackaging levels \nPackaging levels means the various levels of device packag ing that contain a defined quantity of devices, such as \na carton or case. \nUDI-PI \nThe UDI-PI is a numer ic or alphanumer ic code that identif ies the unit of device production. \nThe diffe rent types of UDI-PIs include serial number , lot number , software identif ication and manufactur ing or \nexpir y date or both types of date . 5.5.2017 L 117/117 Official Jour nal of the European Union EN \n Radio Frequency Identification RFID \nRFID is a technology that uses communication through the use of radio wave s to exchange data between \na reader and an electronic tag attac hed to an object, for the purpose of identif ication. \nShipping containers \nA shipping container is a container in relation to whic h traceability is controlled by a process specifi c to logistics \nsystems . \nUnique Device Identif ier (‘UDI’) \nThe UDI is a series of numer ic or alphanumer ic charact ers that is created through a globally accept ed device \nidentif ication and coding standard. It allows the unambiguous identif ication of a specif ic device on the market. \nThe UDI is comprised of the UDI-DI and the UDI-PI. \nThe word ‘Unique ’ does not imply serialisation of individual production units. \nUDI carrier \nThe UDI carrier is the means of conve ying the UDI by using AIDC and, if applicable, its HRI. \nUDI carriers include, inter alia, ID/linear bar code, 2D/Matr ix bar code, RFID. \n2. General requirements \n2.1. The affixing of the UDI is an additional requirement — it does not replace any other marking or labelling \nrequirements laid down in Annex I to this Regulation. \n2.2. The manuf acturer shall assign and maintain unique UDIs for its devices. \n2.3. Only the manuf acturer may place the UDI on the device or its packa ging. \n2.4. Only coding standards provided by issuing entities designat ed by the Commission pursuant to Article 27(2) may \nbe used. \n3. The UDI \n3.1. A UDI shall be assigned to the device itself or its packag ing. Higher levels of packaging shall have their own UDI. \n3.2. Shipping containers shall be exem pted from the requirement in Section 3.1. By way of example, a UDI shall not \nbe required on a logistics unit ; where a healthcare provider orders multiple devices using the UDI or model \nnumber of individual devices and the manufa cturer places those devices in a container for shipping or to protect \nthe individually packag ed devices, the container (logistics unit) shall not be subject to UDI requirements. \n3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI. \n3.4. The UDI-DI shall be unique at each level of device packag ing. \n3.5. If a lot number , serial number , software identif ication or expir y date appears on the label, it shall be part of the \nUDI-PI. If there is also a manufactur ing date on the label, it does not need to be included in the UDI-PI. If there \nis only a manufactur ing date on the label, this shall be used as the UDI-PI. \n3.6. Each compo nent that is considered to be a device and is commercially available on its own shall be assigned \na separate UDI unless the compo nents are part of a conf igurable device that is mark ed with its own UDI. \n3.7. System s and procedure packs as refer red to in Article 22 shall be assigned and bear their own UDI. \n3.8. The manuf acturer shall assign the UDI to a device following the relevant coding standard. 5.5.2017 L 117/118 Official Jour nal of the European Union EN \n 3.9. A new UDI-DI shall be required whenever there is a chang e that could lead to misidentif ication of the device \nand/or ambiguity in its traceability ; in particular , any change of one of the following UDI database data elements \nshall require a new UDI-DI: \n(a) name or trade name, \n(b) device version or model, \n(c) labelled as sing le use, \n(d) packag ed sterile, \n(e) need for sterilization before use, \n(f) quantity of devices provided in a packa ge, \n(g) critical warnings or contra-indications: e.g. containing latex or DEHP . \n3.10. Manufactur ers that repack age and/or relabel devices, with their own label shall retain a record of the original \ndevice manuf acturer's UDI. \n4. UDI carrier \n4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself \nand on all higher levels of device packaging. Higher levels do not include shipping containers. \n4.2. In the event of there being signif icant space constraints on the unit of use packag ing, the UDI carrier may be \nplaced on the next higher packa ging level. \n4.3. For sing le-use devices of classes I and IIa packag ed and labelled individually , the UDI carrier shall not be required \nto appear on the pack aging but it shall appear on a higher level of packag ing, e.g. a carton containing several \nindividually packag ed devices. However , when the healthcare provider is not expected to have access, in cases \nsuch as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the \npackag ing of the individual device. \n4.4. For devices excl usively intende d for retail point of sale the UDI-PIs in AIDC shall not be required to appear on \nthe point of sale packaging. \n4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily \nidentif iable. \n4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concate nated or non-concatenat ed in two or more \nbar codes. All parts and elements of the linear bar code shall be distinguishable and identif iable. \n4.7. If there are signif icant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format \nshall be required to appear on the label. For devices intende d to be used outside healthcare facilities, such as \ndevices for home care, the HRI shall however appear on the label even if this results in there being no space for \nthe AIDC. \n4.8. The HRI format shall follow the rules of the UDI code-issuing entity . \n4.9. If the manufacturer is using RFID technology , a linear or 2D bar code in line with the standard provided by the \nissuing entities shall also be provided on the label. \n4.10. Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that \nrequire cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable \nafter each process performed to make the device ready for the subsequent use throughout the intended lifetime \nof the device. The requirement of this Section shall not apply to devices in the following circumstances: \n(a) any type of direct marking would interfe re with the safety or performa nce of the device; \n(b) the device cannot be directly mark ed because it is not technologically feasible. \n4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device. 5.5.2017 L 117/119 Official Jour nal of the European Union EN \n 4.12. If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the \nplacing of the UDI carrier on the packag ing shall not be required. \n4.13. In the case of sing le finished devices made up of multiple parts that must be assembled before their first use, it \nshall be suffi cient to place the UDI carrier on only one part of each device. \n4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or \nstora ge. \n4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to \noperat e or other data. \n5. General principles of the UDI database \n5.1. The UDI database shall suppor t the use of all core UDI database data elements refer red to in Part B of this \nAnnex. \n5.2. Manufactur ers shall be responsible for the initial submission and updat es of the identifying information and \nother device data elements in the UDI database. \n5.3. Appropr iate methods/procedures for validation of the data provided shall be implemented . \n5.4. Manufactur ers shall periodically verify the correctness of all of the data relevant to devices they have placed on \nthe mark et, excep t for devices that are no longer available on the mark et. \n5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in \nconf ormity with this Regulation. \n5.6. The database shall allow for the linking of all the packaging levels of the device. \n5.7. The data for new UDI-DIs shall be available at the time the device is placed on the mark et. \n5.8. Manufactur ers shall update the relevant UDI database record within 30 days of a change being made to an \nelement, whic h does not require a new UDI-DI. \n5.9. Internationally- accept ed standards for data submission and update s shall, wherever possible, be used by the UDI \ndatabase. \n5.10. The user interface of the UDI database shall be available in all official languages of the Union. The use of free- \ntext fields shall, however , be minimized in order to reduce translations. \n5.11. Data relating to devices that are no longer available on the mark et shall be retained in the UDI database. \n6. Rules for specific device types \n6.1. Implantable devices: \n6.1.1. Implantable devices shall, at their lowest level of packaging (‘unit packs ’), be identif ied, or mark ed using AIDC, \nwith a UDI (UDI-DI + UDI-PI); \n6.1.2. The UDI-PI shall have at least the following charact eristics: \n(a) the serial number for active implantable devices, \n(b) the serial number or lot number for other implantable devices. \n6.1.3. The UDI of the implantable device shall be identif iable prior to implantation. \n6.2. Reusable devices requir ing cleaning, disinfection, sterilis ation or refurbishing between uses \n6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure to make the device \nready for the next use. \n6.2.2. The UDI-PI character istics such as the lot or serial number shall be defined by the manufact urer . 5.5.2017 L 117/120 Official Jour nal of the European Union EN \n 6.3. System s and procedure packs as refer red to in Article 22 \n6.3.1. The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure \npack with a UDI including both UDI-DI and UDI-PI. \n6.3.2. Device cont ents of system or procedure packs shall bear a UDI carrier on their packag ing or on the device itself. \nExemp tions: \n(a) individual sing le-use disposable devices, the uses of whic h are generally kno wn to the persons by whom they \nare intended to be used, whic h are contained within a syste m or procedure pack, and whic h are not intende d \nfor individual use outside the conte xt of the system or procedure pack, shall not be required to bear their \nown UDI carrier; \n(b) devices that are exem pted from bear ing a UDI carrier on the relevant level of packag ing shall not be required \nto bear a UDI carrier when included within a system or procedure pack. \n6.3.3. Placement of the UDI carrier on syste ms or procedure packs \n(a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging. \n(b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the \npackag ing of the system or procedure pack or inside transparent packaging. \n6.4. Configurable devices: \n6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the conf igurable device UDI. \n6.4.2. The conf igurable device UDI-DI shall be assigned to groups of conf igurations, not per conf iguration within the \ngroup. A group of configurations is defined as the collection of possible conf igurations for a given device as \ndescr ibed in the technical documentation. \n6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device. \n6.4.4. The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged \nduring the lifetime of the system and shall be identif ied as the conf igurable device UDI. \n6.4.5. Each compo nent that is considered a device and is commercially available on its own shall be assigned a separate \nUDI. \n6.5. Device Software \n6.5.1. UDI assignment Criteria \nThe UDI shall be assigned at the system level of the software. Only software whic h is commercially available on \nits own and software which constitutes a device in itself shall be subject to that requirement. \nThe software identification shall be considered to be the manufactur ing control mecha nism and shall be \ndispla yed in the UDI-PI. \n6.5.2. A new UDI-DI shall be required whenever there is a modification that changes: \n(a) the original performa nce; \n(b) the safety or the intended use of the software; \n(c) interpr etation of data. \nSuch modif ications include new or modified algor ithms, database structures, operating platf orm, archit ecture or \nnew user interfaces or new channels for interoperability . \n6.5.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI. \nMinor software revisions are generally associated with bug fixes, usability enhancements that are not for safety \npurposes, secur ity patches or operating efficiency . \nMinor software revisions shall be identified by a manuf acturer -specific form of identification. 5.5.2017 L 117/121 Official Jour nal of the European Union EN \n 6.5.4. UDI placement criteria for software \n(a) where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the \nhuman readable and AIDC representation of the compl ete UDI. The UDI that is applied to the physical \nmedium containing the software and its packag ing shall be identical to the UDI assigned to the system level \nsoftware; \n(b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, \nsuch as an ‘about’ file, or included on the start-up screen; \n(c) software lacking a user interfa ce such as middleware for image conver sion, shall be capable of transmitting \nthe UDI through an application programming interface (API); \n(d) only the human readable portion of the UDI shall be required in electronic displa ys of the software. The \nmarking of UDI using AIDC shall not be required in the electronic displa ys, such as ‘about’ menu, splash \nscreen etc.; \n(e) the human readable format of the UDI for the software shall include the Application Identif iers (AI) for the \nstandard used by the issuing entities, so as to assist the user in identifying the UDI and determining whic h \nstandard is being used to create the UDI. 5.5.2017 L 117/122 Official Jour nal of the European Union EN",
"title": "ANNEX VI"
}
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REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": {
"heading": "Electronic system on market surveillance",
"text": "Article 100 \nElectronic system on market surveillance \n1. The Commission, in collaboration with the Member State s, shall set up and manage an electronic system to collat e \nand process the following information: \n(a) summar ies of the results of the surveillance activities refer red to in Article 93(4); \n(b) the final inspection repor t refer red to in Article 93(7); \n(c) information in relation to devices presenting an unacceptable risk to health and safet y as referred to in Article 95(2), \n(4) and (6); \n(d) information in relation to non-com pliance of products as refer red to in Article 97(2); \n(e) information in relation to the preventive health protect ion measures refer red to in Article 98(2); \n(f) summar ies of the results of the reviews and assessments of the market surveillance activities of the Member States \nrefer red to in 93(8). 5.5.2017 L 117/81 Official Jour nal of the European Union EN \n 2. The information refer red to in paragraph 1 of this Article shall be immediate ly transmitted through the electronic \nsystem to all compet ent author ities concer ned and, where applicable, to the notified body that issued a certificate in \naccordance with Article 56 for the device concer ned and be accessible to the Member States and to the Commission. \n3. Information exchanged between Member States shall not be made public where to do so might imp air mark et \nsurveillance activities and co-operation between Member State s. \nCHAPTER VIII \nCOOPERA TION BET WEEN MEMBER STATES, MEDIC AL DEVICE COORDINA TION GROUP , EXPERT \nLABORA TORIES, EXPERT PANELS AND DEVICE REGISTERS"
},
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
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"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": {
"heading": "Requirements regarding other clinical investigations",
"text": "Article 82 \nRequirements regarding other clinical investigations \n1. Clinical investig ations, not performe d pursuant to any of the purposes listed in Article 62(1), shall compl y with \nthe provisions of Article 62 (2) and (3), points (b), (c), (d), (f), (h), and (l) of Article 62(4) and Article 62(6). \n2. In order to protect the rights, safety , dignity and well-being of subjects and the scientific and ethical integrity of \nclinical inve stigations not performe d for any of the purposes listed in Article 62(1), each Member State shall define any \nadditional requirements for such investig ations, as appropr iate for each Member State concer ned. \nCHA PTER VII \nPOST -MARKET SUR VEILL ANCE, VIGIL ANCE AND MARKET SUR VEILL ANCE \nSECTION 1 \nPost-market surveillance"
},
"Article 83": {
"heading": "Post-market surveillance system of the manufacturer",
"text": "Article 83 \nPost-mark et surveillance system of the manufacturer \n1. For each device, manufacturers shall plan, establish, document, implement, maintain and updat e a post-market \nsurveillance syste m in a manner that is propor tionat e to the risk class and appropr iate for the type of device. That \nsystem shall be an integral part of the manufacturer's quality manage ment system refer red to in Article 10(9). \n2. The post-market surveillance system shall be suited to actively and systematically gatheri ng, recording and \nanalysing relevant data on the quality , performa nce and safety of a device throughout its entire lifetime, and to drawin g \nthe necessar y conclusions and to deter mining, implemen ting and monitor ing any preventive and corrective actions. \n3. Data gathered by the manuf acturer's post-market surveillance system shall in particular be used: \n(a) to updat e the benefit-r isk deter mination and to improve the risk management as refer red to in Chapt er I of Annex I; \n(b) to updat e the design and manufactur ing information, the instr uctions for use and the labelling; \n(c) to updat e the clinical evaluation; \n(d) to updat e the summar y of safety and clinical perf ormance refer red to in Article 32; \n(e) for the identification of needs for preventive, corrective or field safety corrective action; \n(f) for the identification of options to improve the usability , performa nce and safety of the device; \n(g) when relevant, to contr ibute to the post-marke t surveillance of other devices; and \n(h) to detect and repor t trends in accordance with Article 88. \nThe technical documentation shall be updated according ly. 5.5.2017 L 117/71 Official Jour nal of the European Union EN \n 4. If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identif ied, the \nmanufa cturer shall implement the appropr iate measures and inform the compet ent author ities concer ned and, where \napplicable, the notified body . Where a serious incident is identified or a field safety corrective action is implemented , it \nshall be repor ted in accordance with Article 87."
},
"Article 84": {
"heading": "Post-market surveillance plan",
"text": "Article 84 together with a rationale and descr iption of any preventive and corrective actions taken. Throughout the \nlifetime of the device concer ned, that PSUR shall set out: \n(a) the conclusions of the benefi t-risk determination; \n(b) the main findings of the PMCF; and \n(c) the volume of sales of the device and an estimate evaluation of the size and other character istics of the population \nusing the device and, where practicable, the usage frequency of the device. \nManufactur ers of class IIb and class III devices shall update the PSUR at least annually . That PSUR shall, excep t in the \ncase of custom-made devices, be part of the technical documentation as specified in Annexes II and III. \nManufactur ers of class IIa devices shall updat e the PSUR when necessar y and at least ever y two years. That PSUR shall, \nexcep t in the case of custom-mad e devices, be part of the technical documentation as specifi ed in Annex es II and III. \nFor custom-made devices, the PSUR shall be part of the documentation refer red to in Section 2 of Annex XIII. \n2. For class III devices or implantable devices, manufa cturers shall submit PSURs by means of the electronic system \nreferred to in Article 92 to the notified body involved in the conf ormity assessment in accordance with Article 52. The \nnotified body shall review the repor t and add its evaluation to that electronic syste m with details of any action taken. \nSuch PSURs and the evaluation by the notifi ed body shall be made available to compet ent author ities through that \nelectronic system. \n3. For devices other than those referred to in paragraph 2, manufacturers shall make PSURs available to the notified \nbody involved in the conf ormity assessment and, upon request, to compet ent author ities. 5.5.2017 L 117/72 Official Jour nal of the European Union EN \n SECTION 2 \nVigilance"
},
"Article 85": {
"heading": "Post-market surveillance report",
"text": "Article 85 \nPost-mark et surveillance repor t \nManufactur ers of class I devices shall prepare a post-market surveillance repor t summar ising the results and conclusions \nof the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to \nin Article 84 together with a rationale and descr iption of any preventive and corrective actions taken. The repor t shall \nbe updated when necessar y and made available to the compet ent author ity upon request."
},
"Article 86": {
"heading": "Periodic safety update report [PSUR]",
"text": "Article 86 \nPeriodic safety update repor t \n1. Manufa cturers of class IIa, class IIb and class III devices shall prepare a periodic safety updat e repor t (‘PSUR’) for \neach device and where relevant for each catego ry or group of devices summar ising the results and conclusions of the \nanalyses of the post-market surveillance data gathered as a result of the post-market surveillance plan refer red to in"
},
"Article 87": {
"heading": "Reporting of serious incidents and field safety corrective actions",
"text": "Article 87; \n(e) harmonised forms for the exchange of information between compet ent author ities as referred to in Article 89; \n(f) procedures for the designation of a coordinating compet ent author ity; the coordinat ed evaluation process, including \ntasks and responsibilities of the coordinating compet ent author ity and involvement of other compet ent author ities in \nthis process. \nThe imple menting acts refer red to in the first paragraph shall be adopt ed in accordance with the examination procedure \nreferred to in Article 114(3). 5.5.2017 L 117/76 Official Jour nal of the European Union EN"
},
"Article 88": {
"heading": "Trend reporting",
"text": "Article 88 \nTrend repor ting \n1. Manufa cturers shall repor t, by means of the electronic system refer red to in Article 92, any statistically signif icant \nincrease in the frequency or sever ity of incidents that are not serious incidents or that are expected undesirable side- \neffects that could have a signif icant impact on the benefit-r isk analysis refer red to in Sections 1 and 5 of Annex I and \nwhic h have led or may lead to risks to the health or safety of patients, users or other persons that are unaccept able \nwhen weighed against the intended benefits. The signif icant increase shall be established in compari son to the \nforeseeable frequency or sever ity of such incidents in respect of the device, or cate gory or group of devices, in question \nduring a specific period as specif ied in the technical documentation and product information. \nThe manufacturer shall specify how to manag e the incidents referred to in the first subparagraph and the methodology \nused for determi ning any statistically signif icant increase in the frequency or sever ity of such incidents, as well as the \nobser vation period, in the post-market surveillance plan refer red to in Article 84. \n2. The compet ent author ities may conduct their own assessments on the trend repor ts refer red to in paragraph 1 and \nrequire the manuf acturer to adop t appropr iate measures in accordance with this Regulation in order to ensure the \nprote ction of public health and patient safet y. Each compe tent author ity shall inform the Commission, the other \ncompet ent author ities and the notifi ed body that issued the certificate, of the results of such assessment and of the \nadoptio n of such measures."
},
"Article 89": {
"heading": "Analysis of serious incidents and field safety corrective actions",
"text": "Article 89(5); \n(b) the periodic summar y repor ts by manufacturers refer red to in Article 87(9); \n(c) the repor ts by manufacturers on trends refer red to in Article 88; \n(d) the PSURs referred to in Article 86; \n(e) the field safety notices by manufacturers referred to in Article 89(8); \n(f) the information to be exchanged between the compet ent author ities of the Member State s and between them and \nthe Commission in accordance with Article 89(7) and (9). \nThat electronic system shall include relevant links to the UDI database. \n2. The information referred to in paragraph 1 of this Article shall be made available through the electronic system to \nthe compet ent author ities of the Member State s and to the Commission. The notified bodies shall also have access to \nthat information to the extent that it relates to devices for which they issued a certificate in accordance with Article 53. \n3. The Commission shall ensure that healthcare profes sionals and the public have appropr iate levels of access to the \nelectronic system refer red to in paragraph 1. \n4. On the basis of arrang ements between the Commission and compet ent author ities of third countr ies or intern at\nional organisations, the Commission may grant those compet ent author ities or internatio nal organisations access to the \nelectronic system refer red to in paragraph 1 at the appropr iate level. Those arrange ments shall be based on reciprocity \nand mak e provision for confidentiality and data protection equivalent to those applicable in the Union. \n5. The repor ts on serious incidents referred to in point (a) of Article 87(1) shall be automat ically transmitted, upon \nreceipt, via the electronic system referred to in paragraph 1 of this Article, to the compet ent author ity of the \nMember State in which the incident occur red. \n6. The trend repor ts refer red to in Article 88(1) shall be automatical ly transmitte d upon receip t via the electronic \nsystem referred to in paragraph 1 of this Article to the compet ent author ities of the Member State in whic h the \nincidents occur red. \n7. The repor ts on field safety corrective actions refer red to in point (b) of Article 87(1) shall be automatical ly \ntransmitte d upon receipt via the electronic system refer red to in paragraph 1 of this Article to the compe tent author ities \nof the following Member State s: \n(a) the Member States in whic h the field safet y corrective action is being or is to be under taken; \n(b) the Member State in whic h the manufact urer has its registered place of business. \n8. The periodic summar y repor ts referred to in Article 87(9) shall be automatical ly transmitte d upon receipt via the \nelectronic system refer red to in paragraph 1 of this Article to the compet ent author ity of: \n(a) the Member State or Member States participating in the coordination procedure in accordance with Article 89(9) \nand whic h have agreed on the periodic summar y repor t; \n(b) the Member State in whic h the manufact urer has its registered place of business. \n9. The information referred to in paragraphs 5 to 8 of this Article shall be automa tically transmitted, upon receipt, \nthrough the electronic system referred to in paragraph 1 of this Article, to the notifi ed body that issued the certificate \nfor the device in question in accordance with Article 56. 5.5.2017 L 117/77 Official Jour nal of the European Union EN \n SECTION 3 \nMarke t surveillance"
},
"Article 9": null,
"Article 90": {
"heading": "Analysis of vigilance data",
"text": "Article 90 \nAnalysis of vigilance data \nThe Commission shall, in collaboration with the Member States, put in place system s and processes to actively monitor \nthe data available in the electronic system refer red to in Article 92, in order to identify trends, patter ns or signals in the \ndata that may reveal new risks or safety concer ns. \nWhere a previously unkno wn risk is identif ied or the frequency of an anticipated risk signif icantly and adversely changes \nthe benefit-r isk determination, the compet ent author ity or, where appropr iate, the coordinating compet ent author ity \nshall inform the manufacturer , or where applicable the author ised representative, whic h shall then take the necessar y \ncorrective actions."
},
"Article 91": {
"heading": "Implementing acts",
"text": "Article 91 \nImplementing acts \nThe Commission may, by means of implementing acts, and after consultation of the MDCG, adopt the detailed \narrang ements and procedural aspects necessar y for the implementation of Articles 85 to 90 and 92 as regar ds the \nfollowing: \n(a) the typology of serious incidents and field safet y corrective actions in relation to specifi c devices, or categor ies or \ngroups of devices; \n(b) the repor ting of serious incidents and field safety corrective actions and field safety notices, and the provision of \nperiodic summar y repor ts, post-market surveillance repor ts, PSURs and trend repor ts by manuf acturers as refer red \nto in Articles 85, 86, 87, 88 and 89 respectively ; \n(c) standard structured forms for electronic and non-electronic repor ting, including a minimum data set for repor ting of \nsuspecte d serious incidents by healthcare profess ionals, users and patients; \n(d) timelines for the repor ting of field safet y corrective actions, and for the provision by manufacturers of periodic \nsummar y repor ts and trend repor ts, taking into account the sever ity of the incident to be repor ted as refer red to in"
},
"Article 92": {
"heading": "Electronic system on vigilance and on post-market surveillance",
"text": "Article 92 \nElectronic system on vigilance and on pos t-mark et surveillance \n1. The Commission shall, in collaboration with the Member States, set up and manage an electronic system to collat e \nand process the following information: \n(a) the repor ts by manuf acturers on serious incidents and field safet y corrective actions refer red to in Article 87(1) and"
},
"Article 93": {
"heading": "Market surveillance activities",
"text": "Article 93 \nMark et surveillance activities \n1. The compet ent author ities shall perform appropr iate checks on the conf ormity characteri stics and performa nce of \ndevices including, where appropr iate, a review of documentation and physical or laboratory checks on the basis of \nadequate sam ples. The compet ent author ities shall, in particular , take account of established principles regar ding risk \nassessment and risk management , vigilance data and compl aints. \n2. The compet ent author ities shall draw up annual surveillance activity plans and allocate a suffi cient number of \nmate rial and compet ent human resources in order to carry out those activities taking into account the European market \nsurveillance programme developed by the MDCG pursuant to Article 105 and local circumstances. \n3. In order to fulfil the oblig ations laid down in paragraph 1, the compet ent author ities: \n(a) may require economic operat ors to, inter alia, make available the documentation and information necessar y for the \npurpose of carrying out the author ities' activities and, where justif ied, to provide the necessar y samples of devices or \naccess to devices free of charge; and \n(b) shall carry out both announced and, if necessar y, unannounced inspections of the premises of economic operators, \nas well as suppliers and/or subcontractors, and, where necessar y, at the facilities of professional users. \n4. The compet ent author ities shall prepare an annual summar y of the results of their surveillance activities and make \nit accessible to other compet ent author ities by means of the electronic system referred to in Article 100. \n5. The compet ent author ities may conf iscat e, destro y or other wise render inoperable devices that present an \nunaccep table risk or falsif ied devices where they deem it necessar y to do so in the interests of the protection of public \nhealth. \n6. Follo wing each inspection carried out for the purposes referred to in paragraph 1, the compet ent author ity shall \ndraw up a repor t on the findings of the inspection that concer n compliance with the legal and technical requirements \napplicable under this Regulation. The repor t shall set out any corrective actions needed. \n7. The compet ent author ity which carried out the inspection shall communicate the content of the repor t refer red to \nin paragraph 6 of this Article to the economic operat or that has been the subject of the inspection. Before adopting the \nfinal repor t, the compet ent author ity shall give that economic operat or the oppor tunity to submit comments. That final \ninspection repor t shall be entered in the electronic syste m provided for in Article 100. \n8. The Member States shall review and assess the functioning of their mark et surveillance activities. Such reviews and \nassessments shall be carried out at least ever y four years and the results thereof shall be communicated to the other \nMember States and the Commission. Each Member State shall mak e a summar y of the results accessible to the public by \nmeans of the electronic system referred to in Article 100. \n9. The compet ent author ities of the Member States shall coordinat e their mark et surveillance activities, cooperat e \nwith each other and share with each other and with the Commission the results thereof, to provide for a harmonised \nand high level of mark et surveillance in all Member States. \nWhere appropr iate, the compet ent author ities of the Member State s shall agree on work-shar ing, joint mark et \nsurveillance activities and specialisation. \n10. Where more than one author ity in a Member State is responsible for mark et surveillance and external border \ncontrols, those author ities shall cooperate with each other , by shar ing information relevant to their role and functions. \n11. Where appropr iate, the compet ent author ities of the Member States shall cooperat e with the compet ent \nauthor ities of third countr ies with a view to exchanging information and technical suppor t and promoting activities \nrelating to market surveillance. 5.5.2017 L 117/78 Official Jour nal of the European Union EN"
},
"Article 94": {
"heading": "Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance",
"text": "Article 94 \nEvaluation of devices suspected of presenting an unacceptable risk or other non-compliance \nWhere the compet ent author ities of a Member State, based on data obtained by vigilance or mark et surveillance \nactivities or on other information, have reason to believe that a device: \n(a) may present an unaccep table risk to the health or safety of patients, users or other persons, or to other aspects of \nthe protection of public health; or \n(b) other wise does not comply with the requirements laid down in this Regulation, \nthey shall carry out an evaluation of the device concer ned covering all requirements laid down in this Regulation \nrelating to the risk presented by the device, or to any other non-com pliance of the device. \nThe relevant economic operat ors shall cooperate with the compet ent author ities."
},
"Article 95": {
"heading": "Procedure for dealing with devices presenting an unacceptable risk to health and safety",
"text": "Article 95 \nProcedure for dealing with devices presenting an unaccepta ble risk to health and safety \n1. Where, having performe d an evaluation pursuant to Article 94, the compet ent author ities find that the device \npresents an unaccep table risk to the health or safety of patients, users or other persons, or to other aspects of the \nprote ction of public health, they shall without dela y require the manuf acturer of the devices concer ned, its author ised \nrepresentative and all other relevant economic operat ors to take all appropr iate and duly justified corrective action to \nbring the device into compl iance with the requirements of this Regulation relating to the risk present ed by the device \nand, in a manner that is propor tionate to the nature of the risk, to restr ict the making available of the device on the \nmark et, to subject the making available of the device to specific requirements, to withdraw the device from the market, \nor to recall it, within a reasonable period that is clearly defined and communicated to the relevant economic operat or. \n2. The compet ent author ities shall, without dela y, notify the Commission, the other Member States and, where \na certificate has been issued in accordance with Article 56 for the device concer ned, the notifi ed body that issued that \ncertificate, of the results of the evaluation and of the actions whic h they have required the economic operat ors to take , \nby means of the electronic system referred to in Article 100. \n3. The economic operat ors as refer red to in paragraph 1 shall, without dela y, ensure that all appropr iate corrective \naction is taken throughout the Union in respect of all the devices concer ned that they have made available on the \nmark et. \n4. Where the economic operat or as refer red to in paragraph 1 does not take adequate corrective action within the \nperiod referred to in paragraph 1, the compet ent author ities shall take all appropr iate measures to prohibit or restr ict \nthe making available of the device on their national mark et, to withdra w the device from that mark et or to recall it. \nThe compet ent author ities shall notify the Commission, the other Member State s and the notified body referred to in \nparagraph 2 of this Article, without dela y, of those measures, by means of the electronic system refer red to in"
},
"Article 96": {
"heading": "Procedure for evaluating national measures at Union level",
"text": "Article 96 \nProcedure for evaluating national measures at Union level \n1. Where, within two months of receipt of the notific ation refer red to in Article 95(4), objections are raised by \na Member State against a measure taken by another Member State , or where the Commission considers the measure to \nbe contrar y to Union law, the Commission shall, after consulting the compet ent author ities concer ned and, where \nnecessar y, the economic operators concer ned, evaluate that national measure. On the basis of the results of that \nevaluation, the Commission may decide, by means of implementing acts, whether or not the national measure is \njustified. Those implementing acts shall be adopt ed in accordance with the examination procedure refer red to in"
},
"Article 97": {
"heading": "Other non-compliance",
"text": "Article 97 \nOther non-compliance \n1. Where, having performe d an evaluation pursuant to Article 94, the compet ent author ities of a Member State find \nthat a device does not compl y with the requirements laid down in this Regulation but does not present an unaccep table \nrisk to the health or safety of patients, users or other persons, or to other aspects of the prote ction of public health, they \nshall require the relevant economic operat or to bring the non-com pliance concer ned to an end within a reasonable \nperiod that is clearly defined and communicated to the economic operat or and that is propor tionate to the non- \ncompl iance. \n2. Where the economic operat or does not bring the non-com pliance to an end within the period refer red to in \nparagraph 1 of this Article, the Member State concer ned shall, without dela y, take all appropr iate measures to restr ict or \nprohibit the product being made available on the mark et or to ensure that it is recalled or withdra wn from the market. \nThat Member State shall inform the Commission and the other Member States, without dela y, of those measures, by \nmeans of the electronic system referred to in Article 100. \n3. In order to ensure the unif orm application of this Article, the Commission may, by means of implementing acts, \nspecify appropr iate measures to be taken by compet ent author ities to address given types of non-compliance. Those \nimplementing acts shall be adopt ed in accordance with the examination procedure refer red to in Article 114(3)."
},
"Article 98": {
"heading": "Preventive health protection measures",
"text": "Article 98 \nPrev entiv e health protection measures \n1. Where a Member State, after having performe d an evaluation which indicates a poten tial risk relat ed to a device or \na specific catego ry or group of devices, considers that, in order to protect the health and safet y of patients, users or \nother persons or other aspects of public health, the making available on the mark et or putting into service of a device or \na specifi c categor y or group of devices should be prohibited, restr icted or made subject to particular requirements or \nthat such device or categor y or group of devices should be withdra wn from the mark et or recalled, it may take any \nnecessar y and justif ied measures. 5.5.2017 L 117/80 Official Jour nal of the European Union EN \n 2. The Member State referred to in paragraph 1 shall immediat ely notify the Commission and all other Member States, \ngiving the reasons for its decision, by means of the electronic system refer red to in Article 100. \n3. The Commission, in consultation with the MDCG and, where necessar y, the economic operators concer ned, shall \nassess the national measures taken. The Commission may decide, by means of implementing acts, whether the national \nmeasures are justified or not. In the absence of a Commission decision within six months of their notifi cation, the \nnational measures shall be considered to be justif ied. Those implementing acts shall be adopt ed in accordance with the \nexamination procedure refer red to in Article 114(3). \n4. Where the assessment refer red to in paragraph 3 of this Article demonstrates that the making available on the \nmark et or putting into service of a device, specifi c catego ry or group of devices should be prohibited, restr icted or made \nsubject to particular requirements or that such device or categor y or group of devices should be withdra wn from the \nmark et or recalled in all Member States in order to prote ct the health and safety of patients, users or other persons or \nother aspects of public health, the Commission may adopt implementing acts to take the necessar y and duly justif ied \nmeasures. Those implementing acts shall be adopt ed in accordance with the examination procedure refer red to in"
},
"Article 99": {
"heading": "Good administrative practice",
"text": "Article 99 \nGood administrativ e practice \n1. Any measure adopt ed by the compet ent author ities of the Member States pursuant to Articles 95 to 98 shall state \nthe exact grounds on which it is based. Where such a measure is addressed to a specific economic operat or, the \ncompet ent author ity shall notify without dela y the economic operator concer ned of that measure, and shall at the same \ntime inform that economic operator of the remedies available under the law or the administrative practice of the \nMember State concer ned and of the time limits to whic h such remedies are subject. Where the measure is of general ap\nplicability , it shall be appropr iately published. \n2. Except in cases where immediate action is necessar y for reasons of unacceptable risk to human health or safety , \nthe economic operat or concer ned shall be given the oppor tunity to mak e submissions to the compet ent author ity \nwithin an appropr iate period of time that is clearly defined before any measure is adop ted. \nWhere action has been taken without the economic operat or having had the oppor tunity to mak e submissions as \nreferred to in the first subparagraph, it shall be given the oppor tunity to make submissions as soon as possible and the \naction taken shall be reviewed promp tly thereaf ter. \n3. Any measure adopt ed shall be immediately withdrawn or amended upon the economic operat or's demonstrating \nthat it has taken effective corrective action and that the device is in compl iance with the requirements of this Regulation. \n4. Where a measure adopt ed pursuant to Articles 95 to 98 concer ns a device for whic h a notifi ed body has been \ninvolved in the conf ormity assessment, the compet ent author ities shall by means of the electronic system referred to in"
}
},
"title": "Post-market surveillance, vigilance and market surveillance"
}
|
{
"text": "REQUIREMENTS TO BE MET BY NOTIFIED BODIES \n1. ORGANISA TIONAL AND GENERAL REQUIREMENTS \n1.1. Legal status and organisational structure \n1.1.1. Each notified body shall be established under the national law of a Member State, or under the law of a third \ncountr y with whic h the Union has concluded an agreement in this respect. Its lega l personality and status shall be \nfully documented. Such documentation shall include information about ownership and the legal or natural \npersons exer cising control over the notifi ed body . \n1.1.2. If the notifi ed body is a lega l entity that is part of a larger organisation, the activities of that organisation as well \nas its orga nisational structure and governance, and the relationship with the notifi ed body shall be clearly \ndocument ed. In such cases, the requirements of Section 1.2 are applicable to both the notifi ed body and the \norganisation to whic h it belongs. \n1.1.3. If a notifi ed body wholly or partly owns legal entities established in a Member State or in a third countr y or is \nowned by another legal entity , the activities and responsibilities of those entities, as well as their legal and \noperational relationships with the notified body , shall be clearly defined and documented. Personnel of those \nentities perf orming conf ormity assessment activities under this Regulation shall be subject to the applicable \nrequirements of this Regulation. \n1.1.4. The organisational structure, allocation of responsibilities, repor ting lines and operation of the notified body shall \nbe such that they ensure that there is confidence in the performa nce by the notified body and in the results of \nthe conf ormity assessment activities it conducts. \n1.1.5. The notifi ed body shall clearly document its organisati onal structure and the functions, responsibilities and \nauthor ity of its top- level manage ment and of other personnel who may have an influence upon the performance \nby the notified body and upon the results of its conf ormity assessment activities. \n1.1.6. The notified body shall identify the persons in top- level management that have overall author ity and responsi \nbility for each of the following: \n— the provision of adequate resources for conf ormity assessment activities; \n— the development of procedures and policies for the operation of the notified body ; \n— the super vision of implementation of the procedures, policies and quality manage ment system s of the notified \nbody ; \n— the super vision of the notified body's finances; \n— the activities and decisions taken by the notifi ed body , including contractual agreements; \n— the delegatio n of author ity to personnel and/or committees, where necessar y, for the performa nce of defined \nactivities; \n—the interaction with the author ity responsible for notified bodies and the oblig ations regarding communi \ncations with other compet ent author ities, the Commission and other notified bodies. \n1.2. Independence and impa rtiality \n1.2.1. The notified body shall be a third-par ty body that is independent of the manufacturer of the device in relation to \nwhic h it performs conf ormity assessment activities. The notified body shall also be independent of any other \neconomic operator having an interest in the device as well as of any competit ors of the manuf acturer . This does \nnot preclude the notified body from carrying out conf ormity assessment activities for competing manufacturers . 5.5.2017 L 117/123 Official Jour nal of the European Union EN \n 1.2.2. The notified body shall be organised and operat ed so as to safeg uard the independence, objectivity and \nimpartiality of its activities. The notified body shall document and implement a structure and procedures for \nsafeg uarding imp artiality and for promoting and applying the principles of impa rtiality throughout its \norganisation, personnel and assessment activities. Such procedures shall provide for the identif ication, inve sti\ngation and resolution of any case in whic h a conf lict of inter est may arise, including involvement in consultancy \nservices in the field of devices prior to taking up emplo yment with the notified body . The inve stigation, outcome \nand its resolution shall be documented. \n1.2.3. The notifi ed body , its top- level management and the personnel responsible for carrying out the conf ormity \nassessment tasks shall not: \n(a) be the designer , manufact urer , supplier , installer , purcha ser, owner or maintainer of devices which they assess, \nnor the author ised representative of any of those parties. Such restr iction shall not preclude the purchase and \nuse of assessed devices that are necessar y for the operations of the notifi ed body and the conduct of the \nconf ormity assessment, or the use of such devices for personal purposes; \n(b) be involved in the design, manufa cture or constr uction, mark eting, installation and use, or mainte nance of \nthe devices for which they are designat ed, nor represent the parties engaged in those activities; \n(c) enga ge in any activity that may conf lict with their independence of judge ment or integrit y in relation to \nconf ormity assessment activities for which they are designated; \n(d) offer or provide any service which may jeopardise the conf idence in their independence, impartiality or \nobjectivity . In particular , they shall not offer or provide consultancy services to the manufacturer , its \nauthor ised representative, a supplier or a commercial competit or as regards the design, constr uction, \nmark eting or maint enance of devices or processes under assessment, and \n(e) be linked to any organisation which itself provides consultancy services as refer red to in point (d). Such \nrestr iction does not preclude general training activities that are not client specifi c and that relat e to regulation \nof devices or to related standards. \n1.2.4. Involvement in consultancy services in the field of devices prior to taking up emplo yment with a notifi ed body \nshall be fully documente d at the time of emplo yment and pote ntial conf licts of inter est shall be monitore d and \nresolved in accordance with this Annex. Personnel who were formerly emplo yed by a specific client, or provided \nconsultancy services in the field of devices to that specific client prior to taking up emplo yment with a notifi ed \nbody , shall not be assigned for conf ormity assessment activities for that specific client or companies belonging to \nthe same group for a period of three years. \n1.2.5. The impartiality of notified bodies, of their top- level manage ment and of the assessment personnel shall be \nguarant eed. The level of the remuneration of the top-level management and assessment personnel of a notifi ed \nbody and subcontractors , involved in assessment activities shall not depend on the results of the assessments. \nNotified bodies shall mak e publicly available the declarations of inter est of their top- level manage ment. \n1.2.6. If a notified body is owned by a public entity or institution, independence and absence of any conf lict of interest \nshall be ensured and documente d between, on the one hand, the author ity responsible for notifi ed bodies and/or \nthe compet ent author ity and, on the other hand, the notified body . \n1.2.7. The notified body shall ensure and document that the activities of its subsidiar ies or subcontract ors, or of any \nassociated body , including the activities of its owners do not affect its independence, impartiality or the \nobjectivity of its conf ormity assessment activities. \n1.2.8. The notified body shall operat e in accordance with a set of consiste nt, fair and reasonable term s and conditions, \ntaking into account the interests of small and medium-sized enterprises as defined in Recommen \ndation 2003/361/EC in relation to fees. \n1.2.9. The requirements laid down in this Section in no way preclude exchanges of technical information and regulator y \nguidance between a notified body and a manuf acturer applying for conf ormity assessment. \n1.3. Confidentiality \n1.3.1. The notified body shall have document ed procedures in place ensur ing that its personnel, committee s, \nsubsidiar ies, subcontractor s, and any associated body or personnel of external bodies respect the confidentiality of \nthe information which comes into its possession during the performance of conf ormity assessment activities, \nexce pt when disclosure is required by law. 5.5.2017 L 117/124 Official Jour nal of the European Union EN \n 1.3.2. The personnel of a notifi ed body shall obser ve professional secrecy in carrying out their tasks under this \nRegulation or any provision of national law giving effect to it, excep t in relation to the author ities responsible for \nnotified bodies, compet ent author ities for medical devices in the Member States or the Commission. Propr ietar y \nrights shall be protect ed. The notifi ed body shall have documented procedures in place in respect of the \nrequirements of this Section. \n1.4. Liability \n1.4.1. The notifi ed body shall take out appropr iate liability insurance for its conf ormity assessment activities, unless \nliability is assumed by the Member State in question in accordance with national law or that Member State is \ndirectly responsible for the conf ormity assessment. \n1.4.2. The scope and overall financial value of the liability insurance shall correspond to the level and geographic scope \nof activities of the notified body and be commensurat e with the risk prof ile of the devices certified by the \nnotified body . The liability insurance shall cover cases where the notified body may be obliged to withdra w, \nrestr ict or suspend certificates. \n1.5. Financial requirements \nThe notifi ed body shall have at its disposal the financia l resources required to conduct its conf ormity assessment \nactivities within its scope of designation and relat ed business operations. It shall document and provide evidence \nof its financial capacity and its long-t erm economic viability , taking into account, where relevant, any specifi c \ncircumstances during an initial start-up phase. \n1.6. Participation in coordination activities \n1.6.1. The notifi ed body shall participat e in, or ensure that its assessment personnel is informed of, any relevant stan \ndardisation activities and in the activities of the notifi ed body coordination group refer red to in Article 49 and \nthat its assessment and decision-making personnel are informed of all relevant legislation, guidance and best \npractice documents adopt ed in the framewor k of this Regulation. \n1.6.2. The notifi ed body shall take into consideration guidance and best practice documents. \n2. QUALIT Y MANA GEMENT REQUIREMENTS \n2.1. The notifi ed body shall establish, document, implement, maintain and operate a quality management system that \nis appropr iate to the nature, area and scale of its conf ormity assessment activities and is capable of suppor ting \nand demonstrating the consistent fulfilme nt of the requirements of this Regulation. \n2.2. The quality management system of the notifi ed body shall address at least the following: \n— management system structure and documentation, including policies and objectives for its activities; \n— policies for assignment of activities and responsibilities to personnel; \n— assessment and decision-making processes in accordance with the task s, responsibilities and role of the \nnotifi ed body's personnel and top-level management; \n— the planning, conduct, evaluation and, if necessar y, adapta tion of its conf ormity assessment procedures; \n— control of documents; \n— control of records; \n— management reviews; \n— intern al audits; \n— corrective and preventive actions; \n— complaints and appeals; and \n— continuous training. \nWhere documents are used in various language s, the notifi ed body shall ensure and control that they have the \nsame cont ent. 5.5.2017 L 117/125 Official Jour nal of the European Union EN \n 2.3. The top- level manag ement of the notified body shall ensure that the quality management system is fully \nunderst ood, implement ed and maintained throughout the notified body organisation including subsidiar ies and \nsubcontract ors involved in conf ormity assessment activities pursuant to this Regulation. \n2.4. The notifi ed body shall require all personnel to formally commit themselves by a signature or equivalent to \ncompl y with the procedures defined by the notifi ed body . That commitment shall cover aspects relating to \nconfidentiality and to independence from commercial and other inter ests, and any existing or prior association \nwith clients. The personnel shall be required to complet e written statements indicating their compliance with \nconfidentiality , independence and impartiality principles. \n3. RESOUR CE REQUIREMENTS \n3.1. General \n3.1.1. Notified bodies shall be capable of carrying out all the tasks falling to them under this Regulation with the \nhighest degree of professional integrity and the requisit e compet ence in the specifi c field, whether those tasks are \ncarried out by notifi ed bodies themselves or on their behalf and under their responsibility . \nIn particular , notified bodies shall have the necessar y personnel and possess or have access to all equipment, \nfacilities and compet ence needed to perform properly the technical, scientific and administrative task s entailed in \nthe conf ormity assessment activities in relation to which they have been designated. \nSuch requirement presupposes at all times and for each conf ormity assessment procedure and each type of \ndevices in relation to whic h they have been designated, that the notified body has permanent availability of \nsufficient administrative, technical and scientific personnel who possess exper ience and kno wledge relating to the \nrelevant devices and the corresponding technologies. Such personnel shall be in suffi cient numbers to ensure that \nthe notified body in question can perform the conf ormity assessment tasks, including the assessment of the \nmedical functionality , clinical evaluations and the performa nce and safety of devices, for which it has been \ndesignat ed, having regard to the requirements of this Regulation, in particular , those set out in Annex I. \nA notifi ed body's cumulative compet ences shall be such as to enable it to assess the types of devices for whic h it \nis designate d. The notified body shall have sufficient internal compet ence to critically evaluate assessments \nconduct ed by exte rnal exper tise. Tasks whic h a notified body is precluded from subcontracting are set out in \nSection 4.1. \nPersonnel involved in the manage ment of the operation of a notifi ed body's conf ormity assessment activities for \ndevices shall have appropr iate kno wledge to set up and operat e a system for the selection of assessment and \nverification staff, for verification of their compe tence, for author isation and allocation of their tasks, for \norganisation of their initial and ongoing training and for the assignment of their duties and the monitori ng of \nthose staff, in order to ensure that personnel who carry out and perf orm assessment and verification operations \nare compe tent to fulfil the tasks required of them. \nThe notifi ed body shall identify at least one individual within its top- level management as having overall responsi \nbility for all conf ormity assessment activities in relation to devices. \n3.1.2. The notified body shall ensure that personnel involved in conf ormity assessment activities maintain their qualifi \ncation and exper tise by implementing a syste m for exchange of exper ience and a continuous training and \neducation programme. \n3.1.3. The notified body shall clearly document the extent and limits of duties and responsibilities and the level of auth \norisation of the personnel, including any subcontractor s and external exper ts, involved in conf ormity assessment \nactivities and inform those personnel according ly. \n3.2. Qualification criteria in relation to personnel \n3.2.1. The Notifie d Body shall establish and document qualifi cation criteria and procedures for selection and author is\nation of persons involved in conf ormity assessment activities, including as regards kno wledge, exper ience and \nother compet ence required, and the required initial and ongoing training. The qualifi cation criteria shall address \nthe various functions within the conf ormity assessment process, such as auditing, product evaluation or testing, \ntechnical documentation review and decision-making, as well as the devices, technologies and areas, such as \nbiocom patibility , sterilis ation, tissues and cells of human and animal origin and clinical evaluation, covered by the \nscope of designation. 5.5.2017 L 117/126 Official Jour nal of the European Union EN \n 3.2.2. The qualifi cation criteria refer red to in Section 3.2.1 shall refer to the scope of a notified body's designation in \naccordance with the scope descr iption used by the Member State for the notifi cation refer red to in Article 42(3), \nproviding a suffi cient level of detail for the required qualification within the subdivisions of the scope descr iption. \nSpecific qualific ation criteria shall be defined at least for the assessment of: \n— the pre-clinical evaluation, \n— clinical evaluation, \n— tissues and cells of human and animal origin, \n— functional safety , \n— software, \n— packaging, \n— devices that incor porate as an integral part a medicinal product, \n— devices that are compo sed of substances or of combinations of substances that are absorbed by or locally \ndispersed in the human body and \n— the different types of sterilis ation processes. \n3.2.3. The personnel responsible for establishing qualific ation criteria and for author ising other personnel to perform \nspecific conf ormity assessment activities shall be emplo yed by the notifi ed body itself and shall not be exte rnal \nexper ts or subcontracte d. They shall have proven knowledge and exper ience in all of the following: \n— Union devices legislation and relevant guidance documents; \n— the conf ormity assessment procedures provided for in this Regulation; \n— a broad base of kno wledge of device technologies and the design and manuf acture of devices; \n— the notifi ed body's quality manage ment system, related procedures and the required qualification criteria; \n— training relevant to personnel involved in conf ormity assessment activities in relation to devices; \n— adequate exper ience in conf ormity assessments under this Regulation or previously applicable law within \na notified body . \n3.2.4. The notified body shall have permanent availability of personnel with relevant clinical exper tise and where \npossible such personnel shall be employed by the notified body itself. Such personnel shall be integrat ed \nthroughout the notified body's assessment and decision-making process in order to: \n— identify when specialist input is required for the assessment of the clinical evaluation conduct ed by the \nmanufacturer and identify appropr iately qualifi ed exper ts; \n— appropr iately train external clinical exper ts in the relevant requirements of this Regulation, CS, guidance and \nharmonised standards and ensure that the extern al clinical exper ts are fully aware of the context and \nimplications of their assessment and the advice they provide; \n— be able to review and scientifi cally challenge the clinical data contained within the clinical evaluation, and any \nassociated clinical investigations, and appropr iatel y guide extern al clinical exper ts in the assessment of the \nclinical evaluation present ed by the manuf acturer ; \n— be able to scientificall y evaluate and, if necessar y, challenge the clinical evaluation presented, and the results of \nthe extern al clinical exper ts' assessment of the manuf acturer's clinical evaluation; \n— be able to ascer tain the compara bility and consistency of the assessments of clinical evaluations conduct ed by \nclinical exper ts; \n— be able to mak e an assessment of the manuf acturer's clinical evaluation and a clinical judg ement of the \nopinion provided by any external exper t and make a recommendation to the notifi ed body's decision mak er; \nand \n— be able to draw up records and repor ts demonstrating that the relevant conf ormity assessment activities have \nbeen appropr iately carried out. 5.5.2017 L 117/127 Official Jour nal of the European Union EN \n 3.2.5. The personnel responsible for carrying out product-relat ed reviews (product reviewers), such as technical \ndocumentation reviews or type examination, including aspects such as clinical evaluation, biological safet y, sterili \nsation and software validation, shall have all of the following proven qualif ications: \n— successful compl etion of a university or a technical college degree or equivalent qualification in relevant \nstudies, e.g. medicine, phar macy , engineer ing or other relevant sciences; \n—four years' profess ional exper ience in the field of healthcare products or relat ed activities, such as in manufac \nturing, auditing or researc h, of whic h two years shall be in the design, manuf acture, testing or use of the \ndevice or technology to be assessed or relat ed to the scientifi c aspects to be assessed; \n— kno wledge of device legislation, including the general safety and performa nce requirements set out in",
"title": "ANNEX VII"
}
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REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": {
"heading": "Competent authorities",
"text": "Article 101 \nCompetent author ities \nThe Member States shall designat e the compet ent author ity or author ities responsible for the implementation of this \nRegulation. They shall entr ust their author ities with the powers, resources, equipment and knowledge necessar y for the \nproper perf ormance of their tasks pursuant to this Regulation. The Member States shall communicat e the names and \ncontact details of the compet ent author ities to the Commission which shall publish a list of compet ent author ities."
},
"Article 102": {
"heading": "Cooperation",
"text": "Article 102 \nCooperation \n1. The compet ent author ities of the Member State s shall cooperat e with each other and with the Commission. The \nCommission shall provide for the organisation of exchanges of information necessar y to enable this Regulation to be \napplied unif ormly. \n2. Member States shall, with the suppor t of the Commission, participate , where appropr iate, in initiatives developed \nat intern ational level with the aim of ensur ing cooperation between regulatory author ities in the field of medical devices."
},
"Article 103": {
"heading": "Medical Device Coordination Group [MDCG]",
"text": "Article 103 \nMedical Device Coordination Group \n1. A Medical Device Coordination Group (‘MDCG’) is hereby established. \n2. Each Member State shall appoint to the MDCG, for a three-y ear term which may be renewed, one member and \none alternate each with exper tise in the field of medical devices, and one member and one alternate with exper tise in the \nfield of in vitro diagnostic medical devices. A Member State may choose to appoint only one member and one alternate, \neach with exper tise in both fields. \nThe members of the MDCG shall be chosen for their compet ence and exper ience in the field of medical devices and in \nvitro diagnostic medical devices. They shall represent the compet ent author ities of the Member States. The names and \naffiliation of members shall be made public by the Commission. \nThe altern ates shall represent and vote for the members in their absence. \n3. The MDCG shall meet at regular intervals and, where the situation requires, upon request by the Commission or \na Member State. The meetings shall be attended either by the members appointed for their role and exper tise in the field \nof medical devices, or by the members appointed for their exper tise in the field of in vitro diagnostic medical devices, or \nby the members appointed for their exper tise in both fields, or their alternates, as appropr iate. \n4. The MDCG shall use its best endea vours to reac h consensus. If such consensus cannot be reached, the MDCG shall \ndecide by a major ity of its members. Members with diverging positions may request that their positions and the grounds \non which they are based be recorded in the MDCG's position. \n5. The MDCG shall be chaired by a representative of the Commission. The chair shall not take part in votes of the \nMDCG. 5.5.2017 L 117/82 Official Jour nal of the European Union EN \n 6. The MDCG may invite, on a case-by- case basis, exper ts and other third parties to attend meetings or provide \nwritten contr ibutions. \n7. The MDCG may establish standing or temporar y sub-groups. Where appropr iate, organisations representing the \ninter ests of the medical device industr y, healthcare professionals, laboratori es, patients and consumers at Union level \nshall be invited to such sub-groups in the capacity of obser vers. \n8. The MDCG shall establish its rules of procedure which shall, in particular , lay down procedures for the following: \n— the adopt ion of opinions or recommendations or other positions, including in cases of urgency ; \n— the delegat ion of tasks to repor ting and co-repor ting members; \n— the implementation of Article 107 regarding conf lict of interests; \n— the functioning of sub-groups. \n9. The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99 of Regulation \n(EU) 2017/746."
},
"Article 104": {
"heading": "Support by the Commission",
"text": "Article 104 \nSuppor t by the Commission \nThe Commission shall suppor t the functioning of the cooperation between national compet ent author ities. It shall, in \nparticular , provide for the organisation of exchanges of exper ience between the compet ent author ities and provide \ntechnical, scientifi c and logistic suppor t to the MDCG and its sub-groups. It shall organise the meetings of the MDCG \nand its sub-groups, participat e in those meetings and ensure the appropr iate follow-up."
},
"Article 105": {
"heading": "Tasks of the MDCG",
"text": "Article 105 \nTasks of the MDCG \nUnder this Regulation, the MDCG shall have the following tasks: \n(a) to contr ibut e to the assessment of applicant conf ormity assessment bodies and notifi ed bodies pursuant to the \nprovisions set out in Chapt er IV; \n(b) to advise the Commission, at its request, in matte rs concer ning the coordination group of notifi ed bodies as \nestablished pursuant to Article 49; \n(c) to contr ibute to the development of guidance aimed at ensur ing effective and harmonised implementation of this \nRegulation, in particular regar ding the designation and monitoring of notified bodies, application of the general \nsafety and perf ormance requirements and conduct of clinical evaluations and investig ations by manufacturers , \nassessment by notified bodies and vigilance activities; \n(d) to contr ibute to the continuous monitori ng of technical progress and assessment of whether the general safety and \nperforma nce requirements laid down in this Regulation and Regulation (EU) 2017/746 are adequate to ensure safety \nand performa nce of devices, and thereby contr ibut e to identifying whether there is a need to amend Annex I to this \nRegulation; \n(e) to contr ibute to the development of device standards, of CS and of scientifi c guidelines, including product specif ic \nguidelines, on clinical inve stigation of certain devices in particular implantable devices and class III devices; \n(f) to assist the compet ent author ities of the Member State s in their coordination activities in particular in the fields of \nclassificat ion and the deter mination of the regulatory status of devices, clinical inve stigations, vigilance and mark et \nsurveillance including the development and maint enance of a framework for a European mark et surveillance \nprogramme with the objective of achi eving efficiency and harmonisation of mark et surveillance in the Union, in \naccordance with Article 93; \n(g) to provide advice, either on its own initiative or at request of the Commission, in the assessment of any issue relat ed \nto the imp lementation of this Regulation; \n(h) to contr ibute to harmonised administrative practice with regard to devices in the Member States. 5.5.2017 L 117/83 Official Jour nal of the European Union EN"
},
"Article 106": {
"heading": "Provision of scientific, technical and clinical opinions and advice",
"text": "Article 106. \n(b) The notified body may be requested to present its conclusions as refer red to in point (a) to the exper t panel \nconcer ned. 5.5.2017 L 117/150 Official Jour nal of the European Union EN \n (c) The exper t panel shall decide, under the super vision of the Commission, on the basis of all of the following \ncriteria: \n(i) the novelty of the device or of the related clinical procedure involved, and the possible major clinical or \nhealth impa ct thereof; \n(ii) a signif icantly adverse change in the benefi t-risk profile of a specifi c cate gory or group of devices due to \nscientifi cally valid health concer ns in respect of compo nents or source mater ial or in respect of the \nimpact on health in the case of failure of the device; \n(iii) a significantly increased rate of serious incidents repor ted in accordance with Article 87 in respect of \na specific categor y or group of devices, \nwhether to provide a scientifi c opinion on the clinical evaluation assessment repor t of the notifi ed body \nbased on the clinical evidence provided by the manuf acturer , in particular concer ning the benefi t-risk deter\nmination, the consistency of that evidence with the medical indication or indications and the PMCF plan. \nThat scientific opinion shall be provided within a period of 60 days, starting on the day of receipt of the \ndocuments from the Commission as refer red to in point (a). The reasons for the decision to provide \na scientific opinion on the basis of the criteria in points (i), (ii) and (iii) shall be included in the scientific \nopinion. Where the information submitted is not suffi cient for the exper t panel to reach a conclusion, this \nshall be stated in the scientific opinion. \n(d) The exper t panel may decide, under the super vision of the Commission, on the basis of the criteria laid \ndown in point (c) not to provide a scientific opinion, in whic h case it shall inform the notified body as soon \nas possible and in any event within 21 days of receipt of the documents as refer red to in point (a) from the \nCommission. The exper t panel shall within that time limit provide the notifi ed body and the Commission \nwith the reasons for its decision, whereupon the notified body may proceed with the certification procedure \nof that device. \n(e) The exper t panel shall within 21 days of receipt of the documents from the Commission notify the \nCommission, through Eudamed whether it intends to provide a scientific opinion, pursuant to point (c), or \nwhether it intends not to provide a scientific opinion, pursuant to point (d). \n(f) Where no opinion has been delivered within a period of 60 days, the notified body may proceed with the \ncertification procedure of the device in question. \n(g) The notifi ed body shall give due consideration to the views expressed in the scientifi c opinion of the exper t \npanel. Where the exper t panel finds that the level of clinical evidence is not suffi cient or other wise gives rise \nto serious concer ns about the benefit-r isk determination, the consistency of that evidence with the intende d \npurpose, including the medical indication(s), and with the PMCF plan, the notified body shall, if necessar y, \nadvise the manufacturer to restr ict the intende d purpose of the device to certain groups of patients or certain \nmedical indications and/or to impose a limit on the duration of validity of the certificate, to under take \nspecif ic PMCF studies, to adap t the instr uctions for use or the summar y of safety and performance, or to \nimpose other restr ictions in its conf ormity assessment repor t, as appropr iate. The notified body shall provide \na full justification where it has not followed the advice of the exper t panel in its conf ormity assessment \nrepor t and the Commission shall without prejudice to Article 109 mak e both the scientific opinion of the \nexper t panel and the written justification provided by the notified body publicly available via Eudamed. \n(h) The Commission, after consultation with the Member States and relevant scientifi c exper ts shall provide \nguidance for exper t panels for consistent interpretat ion of the criteria in point (c) before 26 May 2020. \n5.2. Procedure in the case of devices incor porating a medicinal substance \n(a) Where a device incor porates, as an integral part, a substance whic h, if used separately , may be considered to \nbe a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including \na medicinal product derived from human blood or human plasma and that has an action ancillar y to that of \nthe device, the quality , safety and usefulness of the substance shall be verified by analogy with the methods \nspecified in Annex I to Directive 2001/83/EC. 5.5.2017 L 117/151 Official Jour nal of the European Union EN \n (b) Before issuing an EU technical documentation assessment certificate, the notifi ed body shall, having verified \nthe usefulness of the substance as part of the device and taking account of the intended purpose of the \ndevice, seek a scientific opinion from one of the compet ent author ities designat ed by the Member States in \naccordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as \n‘the medicinal products author ity consulte d’ depending on which has been consulte d under this point, on the \nquality and safety of the substance including the benefit or risk of the incor poration of the substance into the \ndevice. Where the device incor porat es a human blood or plasma derivative or a substance that, if used \nseparate ly, may be considered to be a medicinal product falling excl usively within the scope of the Annex to \nRegulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA . \n(c) When issuing its opinion, the medicinal products author ity consult ed shall take into account the manuf actur \ning process and the data relating to the usefulness of incor poration of the substance into the device as \ndetermined by the notified body . \n(d) The medicinal products author ity consulte d shall provide its opinion to the notifi ed body within 210 days of \nreceip t of all the necessar y documentation. \n(e) The scientifi c opinion of the medicinal products author ity consulted, and any possible update of that \nopinion, shall be included in the documentation of the notified body concer ning the device. The notified \nbody shall give due consideration to the views expressed in the scientific opinion when making its decision. \nThe notified body shall not deliver the certificate if the scientific opinion is unfa vourable and shall conve y its \nfinal decision to the medicinal products author ity consulte d. \n(f) Before any change is made with respect to an ancillar y substance incor porated in a device, in particular \nrelat ed to its manufactur ing process, the manufacturer shall inform the notified body of the changes. That \nnotified body shall seek the opinion of the medicinal products author ity consult ed, in order to confir m that \nthe quality and safety of the ancillar y substance remain unchanged. The medicinal products author ity \nconsult ed shall take into account the data relating to the usefulness of incor poration of the substance into \nthe device as deter mined by the notified body , in order to ensure that the changes have no negative impact \non the risk or benefit previously established concer ning the incor poration of the substance into the device. \nThe medicinal products author ity consult ed shall provide its opinion within 60 days after receipt of all the \nnecessar y documentation regarding the changes. The notified body shall not deliver the supplement to the \nEU technical documentation assessment certificate if the scientifi c opinion provided by the medicinal \nproducts author ity consulted is unfa vourable. The notified body shall conve y its final decision to the \nmedicinal products author ity consult ed. \n(g) Where the medicinal products author ity consulted obtains information on the ancillar y substance, whic h \ncould have an impact on the risk or benefi t previously established concer ning the incor poration of the \nsubstance into the device, it shall advise the notifi ed body as to whether this information has an impact on \nthe risk or benefit previously established concer ning the incor poration of the substance into the device. The \nnotified body shall take that advice into account in reconsider ing its assessment of the conf ormity assessment \nprocedure. \n5.3. Procedure in the case of devices manuf actured utilising, or incor porating, tissues or cells of human or animal \norigin, or their derivatives, that are non-viable or rendered non-viable \n5.3.1. Tissues or cells of human origin or their derivatives \n(a) For devices manuf actured utilising derivatives of tissues or cells of human origin that are covered by this \nRegulation in accordance with point (g) of Article 1(6) and for devices that incor porate , as an integra l part, \ntissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, that have an action \nancillar y to that of the device, the notified body shall, prior to issuing an EU technical documentation \nassessment certificate, seek a scientific opinion from one of the compet ent author ities designat ed by the \nMember States in accordance with Directive 2004/23/EC (‘human tissues and cells compet ent author ity’) on \nthe aspects relating to the donation, procurement and testin g of tissues or cells of human origin or their \nderivatives. The notified body shall submit a summar y of the preliminar y conf ormity assessment which \nprovides, among other things, information about the non-viability of the human tissues or cells in question, \ntheir donation, procurement and testing and the risk or benefit of the incor poration of the tissues or cells of \nhuman origin or their derivatives into the device. 5.5.2017 L 117/152 Official Jour nal of the European Union EN \n (b) Within 120 days of receipt of all the necessar y documentation, the human tissues and cells compet ent \nauthor ity shall provide to the notified body its opinion. \n(c) The scientifi c opinion of the human tissues and cells compet ent author ity, and any possible updat e, shall be \nincluded in the documentation of the notified body concer ning the device. The notified body shall give due \nconsideration to the views expressed in the scientific opinion of the human tissues and cells compet ent \nauthor ity when making its decision. The notified body shall not deliver the certificate if that scientific \nopinion is unfa vourable. It shall conve y its final decision to the human tissues and cells compet ent author ity \nconcer ned. \n(d) Before any chang e is made with respect to non-viable tissues or cells of human origin or their derivatives \nincor porat ed in a device, in particular relating to their donation, testing or procurement, the manufacturer \nshall inform the notified body of the intended changes . The notifi ed body shall consult the author ity that was \ninvolved in the initial consultation, in order to conf irm that the quality and safety of the tissues or cells of \nhuman origin or their derivatives incor porate d in the device are maintained. The human tissues and cells \ncompe tent author ity concer ned shall take into account the data relating to the usefulness of incor poration of \nthe tissues or cells of human origin or their derivatives into the device as deter mined by the notified body , in \norder to ensure that the chang es have no nega tive impact on the established benefit-r isk ratio of the addition \nof the tissues or cells of human origin or their derivatives in the device. It shall provide its opinion within \n60 days of receipt of all the necessar y documentation rega rding the intended changes . The notified body shall \nnot deliver a supplement to the EU technical documentation assessment certificate if the scientific opinion is \nunfavourable and shall conve y its final decision to the human tissues and cells compet ent author ity \nconcer ned. \n5.3.2. Tissues or cells of animal origin or their derivatives \nIn the case of devices manuf actured utilising animal tissue which is rendered non-viable or utilising non-viable \nproducts derived from animal tissue, as refer red to in Regulation (EU) No 722/2012, the notifi ed body shall \napply the relevant requirements laid down in that Regulation. \n5.4. Procedure in the case of devices that are composed of substances or of combinations of substances that are \nabsorbed by or locally dispersed in the human body \n(a) The quality and safety of devices that are compo sed of substances or of combinations of substances that are \nintended to be introduced into the human body via a body orifice or applied to the skin and that are \nabsorbed by, or locally dispersed in, the human body , shall be verified where applicable and only in respect \nof the requirements not covered by this Regulation, in accordance with the relevant requirements laid down \nin Annex I to Directive 2001/83/EC for the evaluation of absor ption, distr ibution, metabolism, excre tion, \nlocal tolerance, toxicity , interaction with other devices, medicinal products or other substances and potential \nfor adverse reactions. \n(b) In addition, for devices, or their products of metabolism, that are system ically absorbed by the human body \nin order to achieve their intended purpose, the notifi ed body shall seek a scientific opinion from one of the \ncompe tent author ities designated by the Member States in accordance with Directive 2001/83/EC or from \nthe EMA, either of which to be refer red to in this Section as ‘the medicinal products author ity consult ed’ \ndepending on whic h has been consulted under this point, on the compl iance of the device with the relevant \nrequirements laid down in Annex I to Directive 2001/83/EC. \n(c) The opinion of the medicinal products author ity consulted shall be drawn up within 150 days of receipt of \nall the necessar y documentation. \n(d) The scientifi c opinion of the medicinal products author ity consulted, and any possible update, shall be \nincluded in the documentation of the notified body concer ning the device. The notified body shall give due \nconsideration to the views expressed in the scientific opinion when making its decision and shall conve y its \nfinal decision to the medicinal products author ity consulte d. \n6. Batch verification in the case of devices incor porating, as an integral part, a medicinal substance whic h, if used \nseparately , would be considered to be a medicinal product derived from human blood or human plasma as \nrefer red to in Article 1(8) \nUpon compl eting the manufacture of each batch of devices that incor porat e, as an integral part, a medicinal \nsubstance which , if used separately , would be considered to be a medicinal product derived from human blood 5.5.2017 L 117/153 Official Jour nal of the European Union EN \n or human plasma as refer red to in the first subparagraph of Article 1(8), the manuf acturer shall inform the \nnotifi ed body of the release of the batch of devices and send it the official certificate concer ning the release of \nthe batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or \na laboratory designat ed for that purpose by a Member State in accordance with Article 114(2) of \nDirective 2001/83/EC. \nCHAPTER III \nADMINISTRA TIVE PROVISIONS \n7. The manufa cturer or, where the manuf acturer does not have a registered place of business in a Member State , its \nauthor ised representative shall, for a period ending no sooner than 10 years, and in the case of implantable \ndevices no sooner than 15 years, after the last device has been placed on the mark et, keep at the disposal of the \ncompet ent author ities: \n— the EU declaration of conf ormity , \n— the documentation refer red to in the fifth indent of Section 2.1 and in particular the data and records arising \nfrom the procedures referred to in point (c) of the second paragraph of Section 2.2, \n— information on the changes refer red to in Section 2.4, \n— the documentation refer red to in Section 4.2, and \n— the decisions and repor ts from the notified body as refer red to in this Annex. \n8. Each Member State shall require that the documentation referred to in Section 7 is kept at the disposal of \ncompet ent author ities for the period indicate d in that Section in case a manuf acturer , or its author ised represen \ntative, established within its territory goes bankr upt or ceases its business activity prior to the end of that period. 5.5.2017 L 117/154 Official Jour nal of the European Union EN \n ANNEX X \nCONFORMIT Y ASSESSMENT BASED ON TYPE-EXAMINA TION \n1. EU type-examination is the procedure whereby a notified body ascer tains and certifies that a device, including its \ntechnical documentation and relevant life cycle processes and a corresponding representative sample of the device \nproduction envisaged, fulfils the relevant provisions of this Regulation. \n2. Application \nThe manufacturer shall lodge an application for assessment with a notified body . The application shall include: \n— the name of the manuf acturer and address of the register ed place of business of the manufacturer and, if the \napplication is lodged by the author ised representative, the name of the author ised representative and the \naddress of its registere d place of business, \n— the technical documentation referred to in Annexes II and III. The applicant shall make a representative sample \nof the device production envisag ed (‘type’ ) available to the notified body . The notifi ed body may request other \nsamples as necessar y, and \n— a written declaration that no application has been lodg ed with any other notified body for the same type, or \ninformation about any previous application for the same type that was refused by another notified body or was \nwithdrawn by the manuf acturer or its author ised representative before that other notified body made its final \nassessment. \n3. Assessment \nThe notifi ed body shall: \n(a) examine the application by using staff with proven kno wledge and exper ience regarding the technology \nconcer ned and its clinical application. The notified body may require the application to be compl eted by having \nfurther tests carried out or requesting further evidence to be provided to allow assessment of conf ormity with \nthe relevant requirements of this Regulation. The notifi ed body shall carry out adequate physical or laboratory \ntests in relation to the device or request the manuf acturer to carry out such tests; \n(b) examine and assess the technical documentation for conf ormity with the requirements of this Regulation that \nare applicable to the device and verify that the type has been manufactured in conf ormity with that documen \ntation; it shall also record the items designed in conf ormity with the applicable standards refer red to in"
},
"Article 107": {
"heading": "Conflict of interests",
"text": "Article 107 \nConf lict of interes ts \n1. Members of the MDCG, its sub-groups, and members of exper t panels and exper t laboratories shall not have \nfinancia l or other inter ests in the medical device industr y whic h could affect their impar tiality . They shall under take to \nact in the public inter est and in an independent manner . They shall declare any direct or indirect inter ests they may have \nin the medical device industr y and updat e that declaration whenever a relevant change occurs. The declaration of \ninter ests shall be made publicly available on the Commission website . This Article shall not apply to the representatives \nof stake holder orga nisations participating in the sub-groups of the MDCG. \n2. Exper ts and other third parties invited by the MDCG on a case-b y-case basis shall declare any interests they may \nhave in the issue in question."
},
"Article 108": {
"heading": "Device registers and data banks",
"text": "Article 108 \nDevice regis ters and databanks \nThe Commission and the Member States shall take all appropr iate measures to encourag e the establishment of register s \nand databank s for specifi c types of devices setting common principles to collect comparable information. Such registers \nand databanks shall contr ibut e to the independent evaluation of the long-t erm safety and performa nce of devices, or the \ntraceability of implantable devices, or all of such charact eristics. \nCHAPTER IX \nCONFIDE NTIALIT Y, DATA PROTECTION , FUNDING AND PENAL TIES"
},
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 34": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Cooperation between the Member States, Medical Device Coordination Group and between the Member States and the Commission"
}
|
{
"text": "CLASSIFIC ATION RULES \nCHAPTER I \nDEFINITIONS SPECIFIC TO CLASSIFIC ATION RULES \n1. DURA TION OF USE \n1.1. ‘Transient’ means normally intende d for continuous use for less than 60 minutes. \n1.2. ‘Shor t term ’ means normally intended for continuous use for between 60 minutes and 30 days. \n1.3. ‘Long term ’ means normally intended for continuous use for more than 30 days. \n2. INVASIVE AND ACTIVE DEVICES \n2.1. ‘Body orifice’ means any natural opening in the body , as well as the exte rnal surface of the eyeball, or any \npermanent artificial opening, such as a stoma. \n2.2. ‘Surgically invasive device’ means: \n(a) an invasive device which penetrates inside the body through the surface of the body , including through \nmucous membranes of body orifices with the aid or in the context of a surgical operation; and \n(b) a device whic h produces penetration other than through a body orifice. \n2.3. ‘Reusable surgical instr ument’ means an instr ument intende d for surgical use in cutting, drilling, sawi ng, \nscratchin g, scraping, clampi ng, retracting, clipping or similar procedures, without a connection to an active device \nand which is intende d by the manuf acturer to be reused after appropr iate procedures such as cleaning, \ndisinfection and sterilisation have been carried out. \n2.4. ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to \nsuppor t, modify , replace or restore biological functions or structures with a view to treatment or alleviation of an \nillness, injur y or disability . \n2.5. ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in \ncombination with other devices, to supply information for detecting, diagnosing, monitor ing or treating physio\nlogical conditions, states of health, illnesses or congenital deformities. \n2.6. ‘Central circulat ory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta \ndescendens to the bifurc atio aortae, arteriae coron ariae, arteria carotis communis, arteria carotis exter na, arteria carotis \ninter na, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava super ior and vena cava \ninferio r. \n2.7. ‘Central nervous system ’ means the brain, meninge s and spinal cord. \n2.8. ‘Injured skin or mucous membrane ’ means an area of skin or a mucous membrane presenting a pathological \nchang e or chang e following disease or a wound. \nCHA PTER II \nIMPLEMENTING RULES \n3.1. Application of the classification rules shall be governed by the intende d purpose of the devices. \n3.2. If the device in question is intended to be used in combination with another device, the classification rules shall \napply separately to each of the devices. Accessor ies for a medical device and for a product liste d in Annex XVI \nshall be classifie d in their own right separately from the device with whic h they are used. \n3.3. Software, which drives a device or influences the use of a device, shall fall within the same class as the device. \nIf the software is independent of any other device, it shall be classifie d in its own right. 5.5.2017 L 117/140 Official Jour nal of the European Union EN \n 3.4. If the device is not intende d to be used solely or principally in a specific part of the body , it shall be considered \nand classified on the basis of the most critical specifi ed use. \n3.5. If several rules, or if, within the same rule, several sub-r ules, apply to the same device based on the device's \nintended purpose, the strictest rule and sub-r ule resulting in the higher classificat ion shall apply . \n3.6. In calculating the duration refer red to in Section 1, continuous use shall mean: \n(a) the entire duration of use of the same device without rega rd to temporar y interr uption of use during \na procedure or temporar y remo val for purposes such as cleaning or disinfection of the device. Whether the \ninterr uption of use or the remo val is temporar y shall be established in relation to the duration of the use \nprior to and after the period when the use is interr upted or the device remo ved; and \n(b) the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another \nof the same type. \n3.7. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in \nquestion by itself or when it provides decisive information for the diagnosis. \nCHAPTER III \nCLASSIFIC ATION RULES \n4. NON-INV ASIVE DEVICES \n4.1. Rule 1 \nAll non-in vasive devices are classifie d as class I, unless one of the rules set out hereinaf ter applies. \n4.2. Rule 2 \nAll non-in vasive devices intende d for channelling or storing blood, body liquids, cells or tissues, liquids or gases \nfor the purpose of eventual infusion, administration or introduction into the body are classif ied as class IIa: \n— if they may be connected to a class IIa, class IIb or class III active device; or \n— if they are intended for use for channelling or storing blood or other body liquids or for stor ing organs, parts \nof organs or body cells and tissues, excep t for blood bags; blood bags are classified as class IIb. \nIn all other cases, such devices are classified as class I. \n4.3. Rule 3 \nAll non-invasive devices intended for modifying the biological or chemical compo sition of human tissues or cells, \nblood, other body liquids or other liquids intended for implantation or administration into the body are classified \nas class IIb, unless the treatment for which the device is used consists of filtration, centr ifugation or exchange s of \ngas, heat, in whic h case they are classified as class IIa. \nAll non-in vasive devices consisting of a substance or a mixture of substances intende d to be used in vitro in direct \ncontact with human cells, tissues or orga ns taken from the human body or used in vitro with human embr yos \nbefore their implantation or administration into the body are classified as class III. \n4.4. Rule 4 \nAll non-in vasive devices which come into contact with injured skin or mucous membrane are classifie d as: \n— class I if they are intended to be used as a mechani cal barrier, for compre ssion or for absor ption of exudates; \n— class IIb if they are intende d to be used principally for injur ies to skin which have breached the dermis or \nmucous membrane and can only heal by secondar y intent; 5.5.2017 L 117/141 Official Jour nal of the European Union EN \n — class IIa if they are principally intended to manag e the micro-envi ronment of injured skin or mucous \nmembrane; and \n— class IIa in all other cases. \nThis rule applies also to the invasive devices that come into contact with injured mucous membrane. \n5. INVASIVE DEVICES \n5.1. Rule 5 \nAll invasive devices with respect to body orifices, other than surgically invasive devices, whic h are not intende d \nfor connection to an active device or whic h are intende d for connection to a class I active device are classifie d as: \n— class I if they are intended for transient use; \n— class IIa if they are intended for shor t-term use, excep t if they are used in the oral cavity as far as the phar ynx, \nin an ear canal up to the ear drum or in the nasal cavity , in which case they are classif ied as class I; and \n— class IIb if they are intended for long-ter m use, excep t if they are used in the oral cavity as far as the phar ynx, \nin an ear canal up to the ear drum or in the nasal cavity and are not liable to be absorbed by the mucous \nmembrane, in which case they are classif ied as class IIa. \nAll invasive devices with respect to body orifices, other than surgically inva sive devices, intende d for connection \nto a class IIa, class IIb or class III active device, are classified as class IIa. \n5.2. Rule 6 \nAll surgically invasive devices intended for transient use are classif ied as class IIa unless they: \n— are intended specifi cally to control, diagnose, monitor or correct a defect of the hear t or of the central \ncirculat ory system through direct contact with those parts of the body , in which case they are classif ied as \nclass III; \n— are reusable surgical instr uments, in whic h case they are classified as class I; \n— are intended specifi cally for use in direct contact with the hear t or central circulator y system or the central \nnervous system, in which case they are classified as class III; \n— are intende d to supply energy in the form of ionising radiation in which case they are classif ied as class IIb; \n— have a biological effect or are wholly or mainly absorbed in whic h case they are classified as class IIb; or \n— are intended to administe r medicinal products by means of a deliver y system, if such administration of \na medicinal product is done in a manner that is poten tially hazardous taking account of the mode of \napplication, in whic h case they are classified as class IIb. \n5.3. Rule 7 \nAll surgically invasive devices intended for shor t-term use are classif ied as class IIa unless they: \n— are intended specifi cally to control, diagnose, monitor or correct a defect of the hear t or of the central \ncirculat ory system through direct contact with those parts of the body , in which case they are classif ied as \nclass III; \n— are intended specifi cally for use in direct contact with the hear t or central circulator y system or the central \nnervous system, in which case they are classified as class III; \n— are intende d to supply energy in the form of ionizing radiation in which case they are classif ied as class IIb; \n— have a biological effect or are wholly or mainly absorbed in whic h case they are classified as class III; \n— are intended to undergo chemical change in the body in whic h case they are classified as class IIb, excep t if \nthe devices are placed in the teeth; or \n— are intende d to administ er medicines, in whic h case they are classifie d as class IIb. 5.5.2017 L 117/142 Official Jour nal of the European Union EN \n 5.4. Rule 8 \nAll implantable devices and long-ter m surgically invasive devices are classifie d as class IIb unless they: \n— are intende d to be placed in the teeth, in whic h case they are classifie d as class IIa; \n— are intended to be used in direct contact with the hear t, the central circulat ory system or the central nervous \nsystem, in which case they are classifie d as class III; \n— have a biological effect or are wholly or mainly absorbed, in which case they are classified as class III; \n— are intende d to undergo chemical change in the body in whic h case they are classif ied as class III, excep t if the \ndevices are placed in the teeth; \n— are intende d to administ er medicinal products, in which case they are classif ied as class III; \n— are active implantable devices or their accessor ies, in which cases they are classifie d as class III; \n— are breast implants or surgical meshes, in whic h cases they are classified as class III; \n— are total or partial joint replacements, in whic h case they are classifie d as class III, with the exce ption of \nancillar y compo nents such as screws, wedges , plates and instr uments; or \n— are spinal disc replacement implants or are implantable devices that come into contact with the spinal \ncolumn, in whic h case they are classified as class III with the excep tion of compo nents such as screws, \nwedges, plates and instr uments. \n6. ACTIVE DEVICES \n6.1. Rule 9 \nAll active therapeutic devices intended to administ er or exchang e energy are classified as class IIa unless their \ncharact eristics are such that they may administer energy to or exchange energy with the human body in \na poten tially hazardous way, taking account of the nature, the density and site of application of the energy , in \nwhich case they are classif ied as class IIb. \nAll active devices intended to control or monitor the performa nce of active therapeutic class IIb devices, or \nintended directly to influence the perf ormance of such devices are classified as class IIb. \nAll active devices intende d to emit ionizing radiation for therapeutic purposes, including devices which control or \nmonitor such devices, or which directly influence their perf ormance, are classifie d as class IIb. \nAll active devices that are intended for controlling, monitori ng or directly influencing the perf ormance of active \nimplantable devices are classifie d as class III. \n6.2. Rule 10 \nActive devices intended for diagnosis and monitoring are classif ied as class IIa: \n— if they are intended to supply energy which will be absorbed by the human body , excep t for devices intende d \nto illuminat e the patient's body , in the visible spectr um, in which case they are classif ied as class I; \n— if they are intended to imag e in vivo distr ibution of radiophar maceuticals; or \n— if they are intended to allow direct diagnosis or monitori ng of vital physiological processes, unless they are \nspecifi cally intende d for monitor ing of vital physiological parameter s and the nature of variations of those \nparameter s is such that it could result in immediate dang er to the patient, for instance variations in cardiac \nperforma nce, respiration, activity of the central nervous system , or they are intende d for diagnosis in clinical \nsituations where the patient is in immediate danger , in whic h cases they are classified as class IIb. \nActive devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology , including \ninter ventional radiology devices and devices which control or monitor such devices, or whic h directly influence \ntheir performa nce, are classif ied as class IIb. 5.5.2017 L 117/143 Official Jour nal of the European Union EN \n 6.3. Rule 11 \nSoftware intended to provide information whic h is used to take decisions with diagnosis or therapeutic purposes \nis classif ied as class IIa, exce pt if such decisions have an impact that may cause: \n— death or an irreversible deterioration of a person's state of health, in which case it is in class III; or \n— a serious deter ioration of a person's state of health or a surgical inter vention, in which case it is classified as \nclass IIb. \nSoftware intended to monitor physiological processes is classifie d as class IIa, excep t if it is intended for \nmonitori ng of vital physiological paramete rs, where the nature of variations of those parameter s is such that it \ncould result in immediate dange r to the patient, in whic h case it is classif ied as class IIb. \nAll other software is classif ied as class I. \n6.4. Rule 12 \nAll active devices intended to administer and/or remo ve medicinal products, body liquids or other substances to \nor from the body are classified as class IIa, unless this is done in a manner that is poten tially hazardous, taking \naccount of the nature of the substances involved, of the part of the body concer ned and of the mode of \napplication in which case they are classif ied as class IIb. \n6.5. Rule 13 \nAll other active devices are classif ied as class I. \n7. SPECIAL RULES \n7.1. Rule 14 \nAll devices incor porating, as an integral part, a substance whic h, if used separately , can be considered to be \na medicinal product, as defined in point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product \nderived from human blood or human plasma, as defined in point 10 of Article 1 of that Directive, and that has \nan action ancillar y to that of the devices, are classified as class III. \n7.2. Rule 15 \nAll devices used for contraception or prevention of the transmission of sexually transmitted diseases are classif ied \nas class IIb, unless they are imp lantable or long term invasive devices, in which case they are classif ied as class III. \n7.3. Rule 16 \nAll devices intende d specifi cally to be used for disinf ecting, cleaning, rinsing or, where appropr iate, hydratin g \ncontact lenses are classified as class IIb. \nAll devices intended specifi cally to be used for disinf ecting or sterilis ing medical devices are classified as class IIa, \nunless they are disinfecting solutions or washer -disinfect ors intende d specifically to be used for disinfecting \ninvasive devices, as the end point of processing, in which case they are classif ied as class IIb. \nThis rule does not apply to devices that are intended to clean devices other than contact lenses by means of \nphysical action only . \n7.4. Rule 17 \nDevices specif ically intended for recording of diagnostic images generat ed by X-ra y radiation are classif ied as \nclass IIa. 5.5.2017 L 117/144 Official Jour nal of the European Union EN \n 7.5. Rule 18 \nAll devices manufa ctured utilising tissues or cells of human or animal origin, or their derivatives, whic h are non- \nviable or rendered non-viable, are classif ied as class III, unless such devices are manufactured utilising tissues or \ncells of animal origin, or their derivatives, whic h are non-viable or rendered non-viable and are devices intended \nto come into contact with intact skin only . \n7.6. Rule 19 \nAll devices incor porating or consisting of nanomater ial are classif ied as: \n— class III if they present a high or medium poten tial for internal exposure; \n— class IIb if they present a low poten tial for internal exposure; and \n— class IIa if they present a negligible pote ntial for internal exposure. \n7.7. Rule 20 \nAll invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to \nadminister medicinal products by inhalation are classifie d as class IIa, unless their mode of action has an essential \nimpact on the efficacy and safety of the administe red medicinal product or they are intended to treat life- \nthreatening conditions, in which case they are classif ied as class IIb. \n7.8. Rule 21 \nDevices that are compo sed of substances or of combinations of substances that are intende d to be introduced \ninto the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the \nhuman body are classified as: \n— class III if they , or their products of metabolism, are system ically absorbed by the human body in order to \nachi eve the intended purpose; \n— class III if they achieve their intended purpose in the stomac h or lower gastroint estinal tract and they, or their \nproducts of metabolism, are systemical ly absorbed by the human body ; \n— class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as the phar ynx, \nand achi eve their intended purpose on those cavities; and \n— class IIb in all other cases. \n7.9. Rule 22 \nActive therapeutic devices with an integrated or incor porate d diagnostic function which signif icantly determi nes \nthe patient management by the device, such as closed loop systems or autom ated external defibrillators, are \nclassif ied as class III. 5.5.2017 L 117/145 Official Jour nal of the European Union EN",
"title": "ANNEX VIII"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": {
"heading": "Confidentiality",
"text": "Article 109 \nConf identiality \n1. Unless other wise provided for in this Regulation and without prejudice to existing national provisions and \npractices in the Member States on conf identiality , all parties involved in the application of this Regulation shall respect \nthe conf identiality of information and data obtained in carrying out their tasks in order to prot ect the following: \n(a) personal data, in accordance with Article 110; \n(b) commercially confidential information and trade secrets of a natural or legal person, including intellectual proper ty \nrights; unless disclosure is in the public interest ; \n(c) the effective implementation of this Regulation, in particular for the purpose of inspections, investig ations or audits. \n2. Without prejudice to paragraph 1, information exchanged on a conf idential basis between compet ent author ities \nand between compet ent author ities and the Commission shall not be disclosed without the prior agreement of the \noriginating author ity. \n3. Paragraphs 1 and 2 shall not affect the rights and oblig ations of the Commission, Member States and notified \nbodies with regar d to exchange of information and the dissemination of warnings, nor the obligations of the persons \nconcer ned to provide information under criminal law. 5.5.2017 L 117/86 Official Jour nal of the European Union EN \n 4. The Commission and Member State s may exchange conf idential information with regulatory author ities of third \ncountr ies with which they have concluded bilat eral or multilateral confidentiality arrang ements."
},
"Article 11": null,
"Article 110": {
"heading": "Data protection",
"text": "Article 110 \nData protection \n1. Member States shall apply Directive 95/46/EC to the processing of personal data carried out in the Member State s \npursuant to this Regulation. \n2. Regulation (EC) No 45/2001 shall apply to the processing of personal data carried out by the Commission \npursuant to this Regulation."
},
"Article 111": {
"heading": "Levying of fees",
"text": "Article 111 \nLevying of fees \n1. This Regulation shall be without prejudice to the possibility for Member State s to levy fees for the activities set out \nin this Regulation, provided that the level of the fees is set in a transparent manner and on the basis of cost-reco very \nprinciples. \n2. Member States shall inform the Commission and the other Member States at least three months before the \nstructure and level of fees is to be adop ted. The structure and level of fees shall be made publicly available on request."
},
"Article 112": {
"heading": "Funding of activities related to designation and monitoring of notified bodies",
"text": "Article 112 \nFunding of activities related to designation and monitorin g of notif ied bodies \nThe costs associated with joint assessment activities shall be covered by the Commission. The Commission shall, by \nmeans of implementing acts, lay down the scale and structure of reco verable costs and other necessar y implementing \nrules. Those implementing acts shall be adopt ed in accordance with the examination procedure referred to in"
},
"Article 113": {
"heading": "Penalties",
"text": "Article 113 \nPenalties \nThe Member States shall lay down the rules on penalties applicable for infringe ment of the provisions of this Regulation \nand shall take all measures necessar y to ensure that they are implemented . The penalties provided for shall be effective, \npropor tionate, and dissuasive. The Member State s shall notify the Commission of those rules and of those measures by \n25 Febr uary 2020 and shall notify it, without dela y, of any subsequent amendment affecting them. \nCHA PTER X \nFINAL PROVISIONS"
},
"Article 114": {
"heading": "Committee procedure",
"text": "Article 114 \nCommittee procedure \n1. The Commission shall be assiste d by a Committ ee on Medical Devices. That Committee shall be a committee \nwithin the meaning of Regulation (EU) No 182/2011. \n2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply . \n3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply . \nWhere the committee delivers no opinion, the Commission shall not adopt the draf t implementing act and the third \nsubparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply . \n4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with"
},
"Article 115": {
"heading": "Exercise of the delegation",
"text": "Article 115 \nExercise of the delegation \n1. The power to adop t delegat ed acts is confe rred on the Commission subject to the conditions laid down in this \nArticle. \n2. The power to adopt delegat ed acts referred to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), \n61(8), 70(8) and 106(15) shall be confe rred on the Commission for a period of five years from 25 May 2017. The \nCommission shall draw up a repor t in respect of the delegatio n of power not later than nine months before the end of \nthe five-year period. The delegatio n of power shall be tacitly extended for periods of an identical duration, unless the \nEuropean Parliament or the Council opposes such exte nsion not later than three months before the end of each period. \n3. The deleg ation of power refer red to in Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), \n70(8) and 106(15) may be revok ed at any time by the European Parliament or by the Council. A decision to revok e shall \nput an end to the delegation of the power specified in that decision. It shall take effect the day following the publication \nof the decision in the Official Journal of the European Union or at a later date specif ied therein. It shall not affect the \nvalidity of any delegat ed acts already in force. \n4. Before adopting a delega ted act, the Commission shall consult exper ts designated by each Member State in \naccordance with the principles laid down in the Interi nstitutional Agreement of 13 Apr il 2016 on Bett er Law-Making. \n5. As soon as it adop ts a delegat ed act, the Commission shall notify it simultaneously to the European Parliament and \nto the Council. \n6. A delegat ed act adop ted pursuant to Articles 1(5), 3, 10(4), 18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) \nand 106(15) shall enter into force only if no objection has been expressed either by the European Parliament or by the \nCouncil within a period of three months of notifi cation of that act to the European Parliament and the Council or if, \nbefore the expir y of that period, the European Parliament and the Council have both informed the Commission that \nthey will not object. That period shall be extende d by three months at the initiative of the European Parliament or of the \nCouncil."
},
"Article 116": null,
"Article 117": null,
"Article 118": null,
"Article 119": null,
"Article 12": null,
"Article 120": null,
"Article 121": null,
"Article 122": null,
"Article 123": null,
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 34": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Confidentiality, data protection, funding and penalties"
}
|
{
"text": "CONFORMIT Y ASSESSMENT BASED ON A QUALIT Y MANA GEMENT SYSTEM AND ON ASSESSMENT OF \nTECHNIC AL DOCUMENT ATION \nCHAPTER I \nQUALIT Y MANA GEMENT SYSTEM \n1. The manufact urer shall establish, document and implemen t a quality manage ment system as descr ibed in \nArticle 10(9) and maintain its effectiveness throughout the life cycle of the devices concer ned. The manufacturer \nshall ensure the application of the quality manag ement syste m as specif ied in Section 2 and shall be subject to \naudit, as laid down in Sections 2.3 and 2.4, and to surveillance as specif ied in Section 3. \n2. Quality manage ment system assessment \n2.1. The manuf acturer shall lodg e an application for assessment of its quality manag ement system with a notifi ed \nbody . The application shall include: \n—the name of the manuf acturer and address of its register ed place of business and any additional manufactur \ning site covered by the quality management syste m, and, if the manufacturer's application is lodged by its \nauthor ised representative, the name of the author ised representative and the address of the author ised \nrepresentative's register ed place of business, \n— all relevant information on the device or group of devices covered by the quality management system, \n— a written declaration that no application has been lodged with any other notified body for the same device- \nrelated quality management system, or information about any previous application for the same device- \nrelated quality manag ement system , \n— a draf t of an EU declaration of conf ormity in accordance with Article 19 and Annex IV for the device model \ncovered by the conf ormity assessment procedure, \n— the documentation on the manuf acturer's quality management system, \n— a documente d descr iption of the procedures in place to fulfil the obligations arising from the quality \nmanage ment system and required under this Regulation and the under taking by the manuf acturer in question \nto apply those procedures, \n— a descr iption of the procedures in place to ensure that the quality management syste m remains adequat e and \neffective, and the under taking by the manufa cturer to apply those procedures, \n— the documentation on the manufact urer's post-market surveillance system and, where applicable, on the \nPMCF plan, and the procedures put in place to ensure compliance with the oblig ations resulting from the \nprovisions on vigilance set out in Articles 87 to 92, \n— a descr iption of the procedures in place to keep up to date the post-market surveillance syste m, and, where \napplicable, the PMCF plan, and the procedures ensur ing compliance with the obligations resulting from the \nprovisions on vigilance set out in Articles 87 to 92, as well as the under taking by the manufacturer to apply \nthose procedures, \n— documentation on the clinical evaluation plan, and \n— a descr iption of the procedures in place to keep up to date the clinical evaluation plan, taking into account \nthe state of the art. \n2.2. Implementation of the quality manag ement system shall ensure compl iance with this Regulation. All the \nelements, requirements and provisions adopt ed by the manuf acturer for its quality management syste m shall be \ndocumented in a systemat ic and orderly manner in the form of a quality manual and written policies and \nprocedures such as quality programmes, quality plans and quality records. 5.5.2017 L 117/146 Official Jour nal of the European Union EN \n Moreo ver, the documentation to be submitted for the assessment of the quality management system shall include \nan adequate descr iption of, in particular: \n(a) the manuf acturer's quality objectives; \n(b) the organisation of the business and in particular: \n— the organisational structures with the assignment of staff responsibilities in relation to critical procedures, \nthe responsibilities of the manag erial staff and their organisational author ity, \n— the methods of monitori ng whether the operation of the quality management system is efficient and in \nparticular the ability of that system to achieve the desired design and device quality , including control of \ndevices whic h fail to conf orm, \n— where the design, manuf acture and/or final verification and testing of the devices, or parts of any of \nthose processes, is carried out by another party, the methods of monitoring the efficient operation of the \nquality manag ement system and in particular the type and exte nt of control applied to the other party, \nand \n— where the manufact urer does not have a register ed place of business in a Member State , the draf t \nmandate for the designation of an author ised representative and a letter of intention from the author ised \nrepresentative to accept the mandate; \n(c) the procedures and techniques for monitoring, verifying, validating and controlling the design of the devices \nand the corresponding documentation as well as the data and records arising from those procedures and \ntechniques. Those procedures and techniques shall specifically cover: \n— the strategy for regulatory compl iance, including processes for identif ication of relevant lega l \nrequirements, qualifi cation, classification, handling of equivalence, choice of and compl iance with \nconf ormity assessment procedures, \n— identif ication of applicable general safety and performa nce requirements and solutions to fulfil those \nrequirements, taking applicable CS and, where opted for, harmonised standards or other adequate \nsolutions into account, \n— risk management as referred to in Section 3 of Annex I, \n— the clinical evaluation, pursuant to Article 61 and Annex XIV, including post-market clinical follow-up, \n— solutions for fulfilling the applicable specific requirements regarding design and constr uction, including \nappropr iate pre-clinical evaluation, in particular the requirements of Chapt er II of Annex I, \n— solutions for fulfilling the applicable specific requirements regarding the information to be supplied with \nthe device, in particular the requirements of Chapt er III of Annex I, \n— the device identif ication procedures drawn up and kept up to date from drawings, specif ications or other \nrelevant documents at ever y stage of manuf acture, and \n— management of design or quality management system changes; and \n(d) the verification and quality assurance techniques at the manufactur ing stage and in particular the processes \nand procedures which are to be used, particularly as regards sterilis ation and the relevant documents; and \n(e) the appropr iate tests and trials whic h are to be carried out before, during and after manuf acture, the \nfrequency with which they are to take place, and the test equipment to be used; it shall be possible to trace \nback adequately the calibration of that test equipment. \nIn addition, the manufa cturer shall grant the notified body access to the technical documentation refer red to in \nAnnexes II and III. \n2.3. Audit \nThe notifi ed body shall audit the quality manage ment system to determine whether it meets the requirements \nrefer red to in Section 2.2. Where the manufacturer uses a harmonised standard or CS relat ed to a quality \nmanagement syste m, the notifi ed body shall assess conf ormity with those standards or CS. The notifi ed body \nshall assume that a quality management system which satisfi es the relevant harmonised standards or CS \nconf orms to the requirements covered by those standards or CS, unless it duly substantiate s not doing so. 5.5.2017 L 117/147 Official Jour nal of the European Union EN \n The audit team of the notifi ed body shall include at least one member with past exper ience of assessments of the \ntechnology concer ned in accordance with Sections 4.3. to 4.5. of Annex VII. In circumstances where such \nexper ience is not immediately obvious or applicable, the notified body shall provide a documented rationale for \nthe compo sition of that team. The assessment procedure shall include an audit on the manufa cturer's premises \nand, if appropr iate, on the premises of the manufact urer's suppliers and/or subcontractor s to verify the manufa c\nturing and other relevant processes. \nMoreo ver, in the case of class IIa and class IIb devices, the quality manag ement system assessment shall be \naccompanied by the assessment of technical documentation for devices selected on a representative basis in \naccordance with Sections 4.4 to 4.8. In choosing representative sam ples, the notified body shall take into \naccount the published guidance developed by the MDCG pursuant to Article 105 and in particular the novelty of \nthe technology , similar ities in design, technology , manuf actur ing and steril isation methods, the intended purpose \nand the results of any previous relevant assessments such as with regar d to physical, chemical, biological or \nclinical proper ties, that have been carried out in accordance with this Regulation. The notifi ed body in question \nshall document its rationale for the sample s taken. \nIf the quality managemen t system conf orms to the relevant provisions of this Regulation, the notified body shall \nissue an EU quality managemen t syste m certificate. The notified body shall notify the manufacturer of its \ndecision to issue the certificate. The decision shall contain the conclusions of the audit and a reasoned repor t. \n2.4. The manufact urer in question shall inform the notified body which appro ved the quality manage ment system of \nany plan for substantial chang es to the quality manage ment system, or the device-range covered. The notified \nbody shall assess the chang es proposed, determine the need for additional audits and verify whether after those \nchang es the quality management system still meets the requirements refer red to in Section 2.2. It shall notify the \nmanufacturer of its decision whic h shall contain the conclusions of the assessment, and where applicable, \nconclusions of additional audits. The appro val of any substantial chang e to the quality manag ement system or \nthe device-range covered shall take the form of a supplement to the EU quality management system certificate. \n3. Surveillance assessment applicable to class IIa, class IIb and class III devices \n3.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the oblig ations arising from the appro ved \nquality management system. \n3.2. The manufacturer shall give author isation to the notified body to carry out all the necessar y audits, including on- \nsite audits, and supply it with all relevant information, in particular: \n— the documentation on its quality manag ement syste m, \n— documentation on any findings and conclusions resulting from the application of the post-market \nsurveillance plan, including the PMCF plan, for a representative sample of devices, and of the provisions on \nvigilance set out in Articles 87 to 92, \n— the data stipulat ed in the part of the quality management syste m relating to design, such as the results of \nanalyses, calculations, tests and the solutions adopt ed regarding the risk-manage ment as refer red to in \nSection 4 of Annex I, and \n— the data stipulat ed in the part of the quality management system relating to manufacture, such as quality \ncontrol repor ts and test data, calibration data, and records on the qualifications of the personnel concer ned. \n3.3. Notif ied bodies shall periodically , at least once ever y 12 months, carry out appropr iate audits and assessments to \nmake sure that the manuf acturer in question applies the appro ved quality manage ment system and the post- \nmarket surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer \nand, if appropr iate, of the manufacturer's suppliers and/or subcontractor s. At the time of such on-site audits, the \nnotifi ed body shall, where necessar y, carry out or ask for tests in order to check that the quality management \nsystem is working properly . It shall provide the manufact urer with a surveillance audit repor t and, if a test has \nbeen carried out, with a test repor t. \n3.4. The notifi ed body shall randomly perform at least once ever y five years unannounced audits on the site of the \nmanufacturer and, where appropr iate, of the manuf acturer's suppliers and/or subcontractors, which may be \ncombined with the periodic surveillance assessment refer red to in Section 3.3. or be performe d in addition to \nthat surveillance assessment. The notified body shall establish a plan for such unannounced on-site audits but \nshall not disclose it to the manufa cturer . 5.5.2017 L 117/148 Official Jour nal of the European Union EN \n Within the conte xt of such unannounced on-site audits, the notified body shall test an adequate sample of the \ndevices produced or an adequate sample from the manuf actur ing process to verify that the manufactured device \nis in conf ormity with the technical documentation, with the excep tion of the devices referred to in the second \nsubparagraph of Article 52(8). Prior to unannounced on-site audits, the notified body shall specify the relevant \nsampling criteria and testing procedure. \nInstead of, or in addition to, samp ling referred to in the second paragraph, the notifi ed body shall take sam ples \nof devices from the mark et to verify that the manufa ctured device is in conf ormity with the technical documen \ntation, with the excep tion of the devices refer red to in the second subparagraph of Article 52(8). Prior to the \nsampling, the notifi ed body in question shall specify the relevant sam pling criteria and testin g procedure. \nThe notifi ed body shall provide the manufacturer in question with an on-site audit repor t whic h shall include, if \napplicable, the result of the sample test. \n3.5. In the case of class IIa and class IIb devices, the surveillance assessment shall also include an assessment of the \ntechnical documentation as refer red to in Sections 4.4 to 4.8 for the device or devices concer ned on the basis of \nfurther representative samples chosen in accordance with the rationale documented by the notifi ed body in \naccordance with the second paragraph of Section 2.3. \nIn the case of class III devices, the surveillance assessment shall also include a test of the appro ved parts and/or \nmater ials that are essential for the integrity of the device, including, where appropr iate, a check that the \nquantities of produced or purcha sed parts and/or mater ials correspond to the quantities of finished devices. \n3.6. The notified body shall ensure that the compo sition of the assessment team is such that there is sufficient \nexper ience with the evaluation of the devices, system s and processes concer ned, continuous objectivity and \nneutrality ; this shall include a rotation of the members of the assessment team at appropr iate intervals. As \na general rule, a lead auditor shall neither lead nor attend audits for more than three consecutive years in respect \nof the same manufacturer . \n3.7. If the notified body finds a divergence between the sam ple taken from the devices produced or from the mark et \nand the specifi cations laid down in the technical documentation or the appro ved design, it shall suspend or \nwithdraw the relevant certificate or impose restr ictions on it. \nCHA PTER II \nASSESSMENT OF THE TECHNIC AL DOCUMENT ATION \n4. Assessment of the technical documentation applicable to class III devices and to the class IIb devices referred to \nin the second subparagraph of Article 52(4) \n4.1. In addition to the oblig ations laid down in Section 2, the manufacturer shall lodge with the notifi ed body an \napplication for assessment of the technical documentation relating to the device which it plans to place on the \nmarket or put into service and which is covered by the quality manag ement syste m refer red to in Section 2. \n4.2. The application shall descr ibe the design, manufa cture and performa nce of the device in question. It shall include \nthe technical documentation as refer red to in Annex es II and III. \n4.3. The notified body shall examine the application by using staff, emplo yed by it, with proven kno wledge and \nexper ience regar ding the technology concer ned and its clinical application. The notified body may require the \napplication to be complet ed by having further tests carried out or requesting further evidence to be provided to \nallow assessment of conf ormity with the relevant requirements of the Regulation. The notified body shall carry \nout adequate physical or laboratory tests in relation to the device or request the manufa cturer to carry out such \ntests. \n4.4. The notified body shall review the clinical evidence present ed by the manufacturer in the clinical evaluation \nrepor t and the related clinical evaluation that was conduct ed. The notifi ed body shall emplo y device reviewers \nwith suffic ient clinical exper tise and, if necessar y, use extern al clinical exper ts with direct and current exper ience \nrelating to the device in question or the clinical condition in whic h it is utilised, for the purposes of that review . 5.5.2017 L 117/149 Official Jour nal of the European Union EN \n 4.5. The notifi ed body shall, in circumstances in whic h the clinical evidence is based partly or totally on data from \ndevices which are claimed to be equivalent to the device under assessment, assess the suitability of using such \ndata, taking into account factors such as new indications and inno vation. The notifi ed body shall clearly \ndocument its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for \ndemonstrating conf ormity . For any charact eristic of the device claimed as inno vative by the manufacturer or for \nnew indications, the notified body shall assess to what extent specif ic claims are suppor ted by specifi c pre-clinical \nand clinical data and risk analysis. \n4.6. The notified body shall verify that the clinical evidence and the clinical evaluation are adequat e and shall verify \nthe conclusions drawn by the manufa cturer on the conf ormity with the relevant general safety and performa nce \nrequirements. That verification shall include consideration of the adequacy of the benefit-r isk deter mination, the \nrisk management , the instr uctions for use, the user training and the manuf acturer's post-market surveillance \nplan, and include a review of the need for, and the adequacy of, the PMCF plan proposed, where applicable. \n4.7. Based on its assessment of the clinical evidence, the notified body shall consider the clinical evaluation and the \nbenefi t-risk deter mination, and whether specifi c milestone s need to be defined to allow the notifi ed body to \nreview update s to the clinical evidence that result from post-marke t surveillance and PMCF data. \n4.8. The notified body shall clearly document the outcome of its assessment in the clinical evaluation assessment \nrepor t. \n4.9. The notified body shall provide the manuf acturer with a repor t on the technical documentation assessment, \nincluding a clinical evaluation assessment repor t. If the device conf orms to the relevant provisions of this \nRegulation, the notified body shall issue an EU technical documentation assessment certificate. The certificate \nshall contain the conclusions of the technical documentation assessment, the conditions of the certificate's \nvalidity , the data needed for identif ication of the appro ved design, and, where appropr iate, a descr iption of the \nintended purpose of the device. \n4.10. Changes to the appro ved device shall require appro val from the notified body whic h issued the EU technical \ndocumentation assessment certificate where such chang es could affect the safety and performa nce of the device \nor the conditions prescr ibed for use of the device. Where the manuf acturer plans to introduce any of the above- \nmentioned changes it shall inform the notified body which issued the EU technical documentation assessment \ncertificate thereof. The notified body shall assess the planned chang es and decide whether the planned chang es \nrequire a new conf ormity assessment in accordance with Article 52 or whether they could be addressed by \nmeans of a supplement to the EU technical documentation assessment certificate. In the latter case, the notified \nbody shall assess the changes, notify the manufa cturer of its decision and, where the change s are appro ved, \nprovide it with a supplement to the EU technical documentation assessment certificate. \n5. Specifi c additional procedures \n5.1. Assessment procedure for certain class III and class IIb devices \n(a) For class III implantable devices, and for class IIb active devices intende d to administ er and/or remo ve \na medicinal product as refer red to in Section 6.4. of Annex VIII (Rule 12), the notifi ed body shall, having \nverified the quality of clinical data suppor ting the clinical evaluation repor t of the manuf acturer refer red to in \nArticle 61(12), prepare a clinical evaluation assessment repor t which sets out its conclusions concer ning the \nclinical evidence provided by the manufa cturer , in particular concer ning the benefi t-risk determi nation, the \nconsistency of that evidence with the intended purpose, including the medical indication or indications and \nthe PMCF plan refer red to in Article 10(3) and Part B of Annex XIV. \nThe notifi ed body shall transmit its clinical evaluation assessment repor t, along with the manufacturer's \nclinical evaluation documentation, referred to in points (c) and (d) of Section 6.1 of Annex II, to the \nCommission. \nThe Commission shall immediately transmit those documents to the relevant exper t panel referred to in \nArticle 106. \n(b) The notified body may be requested to present its conclusions as refer red to in point (a) to the exper t panel \nconcer ned. 5.5.2017 L 117/150 Official Jour nal of the European Union EN \n (c) The exper t panel shall decide, under the super vision of the Commission, on the basis of all of the following \ncriteria: \n(i) the novelty of the device or of the related clinical procedure involved, and the possible major clinical or \nhealth impa ct thereof; \n(ii) a signif icantly adverse change in the benefi t-risk profile of a specifi c cate gory or group of devices due to \nscientifi cally valid health concer ns in respect of compo nents or source mater ial or in respect of the \nimpact on health in the case of failure of the device; \n(iii) a significantly increased rate of serious incidents repor ted in accordance with Article 87 in respect of \na specific categor y or group of devices, \nwhether to provide a scientifi c opinion on the clinical evaluation assessment repor t of the notifi ed body \nbased on the clinical evidence provided by the manuf acturer , in particular concer ning the benefi t-risk deter\nmination, the consistency of that evidence with the medical indication or indications and the PMCF plan. \nThat scientific opinion shall be provided within a period of 60 days, starting on the day of receipt of the \ndocuments from the Commission as refer red to in point (a). The reasons for the decision to provide \na scientific opinion on the basis of the criteria in points (i), (ii) and (iii) shall be included in the scientific \nopinion. Where the information submitted is not suffi cient for the exper t panel to reach a conclusion, this \nshall be stated in the scientific opinion. \n(d) The exper t panel may decide, under the super vision of the Commission, on the basis of the criteria laid \ndown in point (c) not to provide a scientific opinion, in whic h case it shall inform the notified body as soon \nas possible and in any event within 21 days of receipt of the documents as refer red to in point (a) from the \nCommission. The exper t panel shall within that time limit provide the notifi ed body and the Commission \nwith the reasons for its decision, whereupon the notified body may proceed with the certification procedure \nof that device. \n(e) The exper t panel shall within 21 days of receipt of the documents from the Commission notify the \nCommission, through Eudamed whether it intends to provide a scientific opinion, pursuant to point (c), or \nwhether it intends not to provide a scientific opinion, pursuant to point (d). \n(f) Where no opinion has been delivered within a period of 60 days, the notified body may proceed with the \ncertification procedure of the device in question. \n(g) The notifi ed body shall give due consideration to the views expressed in the scientifi c opinion of the exper t \npanel. Where the exper t panel finds that the level of clinical evidence is not suffi cient or other wise gives rise \nto serious concer ns about the benefit-r isk determination, the consistency of that evidence with the intende d \npurpose, including the medical indication(s), and with the PMCF plan, the notified body shall, if necessar y, \nadvise the manufacturer to restr ict the intende d purpose of the device to certain groups of patients or certain \nmedical indications and/or to impose a limit on the duration of validity of the certificate, to under take \nspecif ic PMCF studies, to adap t the instr uctions for use or the summar y of safety and performance, or to \nimpose other restr ictions in its conf ormity assessment repor t, as appropr iate. The notified body shall provide \na full justification where it has not followed the advice of the exper t panel in its conf ormity assessment \nrepor t and the Commission shall without prejudice to Article 109 mak e both the scientific opinion of the \nexper t panel and the written justification provided by the notified body publicly available via Eudamed. \n(h) The Commission, after consultation with the Member States and relevant scientifi c exper ts shall provide \nguidance for exper t panels for consistent interpretat ion of the criteria in point (c) before 26 May 2020. \n5.2. Procedure in the case of devices incor porating a medicinal substance \n(a) Where a device incor porates, as an integral part, a substance whic h, if used separately , may be considered to \nbe a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including \na medicinal product derived from human blood or human plasma and that has an action ancillar y to that of \nthe device, the quality , safety and usefulness of the substance shall be verified by analogy with the methods \nspecified in Annex I to Directive 2001/83/EC. 5.5.2017 L 117/151 Official Jour nal of the European Union EN \n (b) Before issuing an EU technical documentation assessment certificate, the notifi ed body shall, having verified \nthe usefulness of the substance as part of the device and taking account of the intended purpose of the \ndevice, seek a scientific opinion from one of the compet ent author ities designat ed by the Member States in \naccordance with Directive 2001/83/EC or from the EMA, either of which to be referred to in this Section as \n‘the medicinal products author ity consulte d’ depending on which has been consulte d under this point, on the \nquality and safety of the substance including the benefit or risk of the incor poration of the substance into the \ndevice. Where the device incor porat es a human blood or plasma derivative or a substance that, if used \nseparate ly, may be considered to be a medicinal product falling excl usively within the scope of the Annex to \nRegulation (EC) No 726/2004, the notified body shall seek the opinion of the EMA . \n(c) When issuing its opinion, the medicinal products author ity consult ed shall take into account the manuf actur \ning process and the data relating to the usefulness of incor poration of the substance into the device as \ndetermined by the notified body . \n(d) The medicinal products author ity consulte d shall provide its opinion to the notifi ed body within 210 days of \nreceip t of all the necessar y documentation. \n(e) The scientifi c opinion of the medicinal products author ity consulted, and any possible update of that \nopinion, shall be included in the documentation of the notified body concer ning the device. The notified \nbody shall give due consideration to the views expressed in the scientific opinion when making its decision. \nThe notified body shall not deliver the certificate if the scientific opinion is unfa vourable and shall conve y its \nfinal decision to the medicinal products author ity consulte d. \n(f) Before any change is made with respect to an ancillar y substance incor porated in a device, in particular \nrelat ed to its manufactur ing process, the manufacturer shall inform the notified body of the changes. That \nnotified body shall seek the opinion of the medicinal products author ity consult ed, in order to confir m that \nthe quality and safety of the ancillar y substance remain unchanged. The medicinal products author ity \nconsult ed shall take into account the data relating to the usefulness of incor poration of the substance into \nthe device as deter mined by the notified body , in order to ensure that the changes have no negative impact \non the risk or benefit previously established concer ning the incor poration of the substance into the device. \nThe medicinal products author ity consult ed shall provide its opinion within 60 days after receipt of all the \nnecessar y documentation regarding the changes. The notified body shall not deliver the supplement to the \nEU technical documentation assessment certificate if the scientifi c opinion provided by the medicinal \nproducts author ity consulted is unfa vourable. The notified body shall conve y its final decision to the \nmedicinal products author ity consult ed. \n(g) Where the medicinal products author ity consulted obtains information on the ancillar y substance, whic h \ncould have an impact on the risk or benefi t previously established concer ning the incor poration of the \nsubstance into the device, it shall advise the notifi ed body as to whether this information has an impact on \nthe risk or benefit previously established concer ning the incor poration of the substance into the device. The \nnotified body shall take that advice into account in reconsider ing its assessment of the conf ormity assessment \nprocedure. \n5.3. Procedure in the case of devices manuf actured utilising, or incor porating, tissues or cells of human or animal \norigin, or their derivatives, that are non-viable or rendered non-viable \n5.3.1. Tissues or cells of human origin or their derivatives \n(a) For devices manuf actured utilising derivatives of tissues or cells of human origin that are covered by this \nRegulation in accordance with point (g) of Article 1(6) and for devices that incor porate , as an integra l part, \ntissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, that have an action \nancillar y to that of the device, the notified body shall, prior to issuing an EU technical documentation \nassessment certificate, seek a scientific opinion from one of the compet ent author ities designat ed by the \nMember States in accordance with Directive 2004/23/EC (‘human tissues and cells compet ent author ity’) on \nthe aspects relating to the donation, procurement and testin g of tissues or cells of human origin or their \nderivatives. The notified body shall submit a summar y of the preliminar y conf ormity assessment which \nprovides, among other things, information about the non-viability of the human tissues or cells in question, \ntheir donation, procurement and testing and the risk or benefit of the incor poration of the tissues or cells of \nhuman origin or their derivatives into the device. 5.5.2017 L 117/152 Official Jour nal of the European Union EN \n (b) Within 120 days of receipt of all the necessar y documentation, the human tissues and cells compet ent \nauthor ity shall provide to the notified body its opinion. \n(c) The scientifi c opinion of the human tissues and cells compet ent author ity, and any possible updat e, shall be \nincluded in the documentation of the notified body concer ning the device. The notified body shall give due \nconsideration to the views expressed in the scientific opinion of the human tissues and cells compet ent \nauthor ity when making its decision. The notified body shall not deliver the certificate if that scientific \nopinion is unfa vourable. It shall conve y its final decision to the human tissues and cells compet ent author ity \nconcer ned. \n(d) Before any chang e is made with respect to non-viable tissues or cells of human origin or their derivatives \nincor porat ed in a device, in particular relating to their donation, testing or procurement, the manufacturer \nshall inform the notified body of the intended changes . The notifi ed body shall consult the author ity that was \ninvolved in the initial consultation, in order to conf irm that the quality and safety of the tissues or cells of \nhuman origin or their derivatives incor porate d in the device are maintained. The human tissues and cells \ncompe tent author ity concer ned shall take into account the data relating to the usefulness of incor poration of \nthe tissues or cells of human origin or their derivatives into the device as deter mined by the notified body , in \norder to ensure that the chang es have no nega tive impact on the established benefit-r isk ratio of the addition \nof the tissues or cells of human origin or their derivatives in the device. It shall provide its opinion within \n60 days of receipt of all the necessar y documentation rega rding the intended changes . The notified body shall \nnot deliver a supplement to the EU technical documentation assessment certificate if the scientific opinion is \nunfavourable and shall conve y its final decision to the human tissues and cells compet ent author ity \nconcer ned. \n5.3.2. Tissues or cells of animal origin or their derivatives \nIn the case of devices manuf actured utilising animal tissue which is rendered non-viable or utilising non-viable \nproducts derived from animal tissue, as refer red to in Regulation (EU) No 722/2012, the notifi ed body shall \napply the relevant requirements laid down in that Regulation. \n5.4. Procedure in the case of devices that are composed of substances or of combinations of substances that are \nabsorbed by or locally dispersed in the human body \n(a) The quality and safety of devices that are compo sed of substances or of combinations of substances that are \nintended to be introduced into the human body via a body orifice or applied to the skin and that are \nabsorbed by, or locally dispersed in, the human body , shall be verified where applicable and only in respect \nof the requirements not covered by this Regulation, in accordance with the relevant requirements laid down \nin Annex I to Directive 2001/83/EC for the evaluation of absor ption, distr ibution, metabolism, excre tion, \nlocal tolerance, toxicity , interaction with other devices, medicinal products or other substances and potential \nfor adverse reactions. \n(b) In addition, for devices, or their products of metabolism, that are system ically absorbed by the human body \nin order to achieve their intended purpose, the notifi ed body shall seek a scientific opinion from one of the \ncompe tent author ities designated by the Member States in accordance with Directive 2001/83/EC or from \nthe EMA, either of which to be refer red to in this Section as ‘the medicinal products author ity consult ed’ \ndepending on whic h has been consulted under this point, on the compl iance of the device with the relevant \nrequirements laid down in Annex I to Directive 2001/83/EC. \n(c) The opinion of the medicinal products author ity consulted shall be drawn up within 150 days of receipt of \nall the necessar y documentation. \n(d) The scientifi c opinion of the medicinal products author ity consulted, and any possible update, shall be \nincluded in the documentation of the notified body concer ning the device. The notified body shall give due \nconsideration to the views expressed in the scientific opinion when making its decision and shall conve y its \nfinal decision to the medicinal products author ity consulte d. \n6. Batch verification in the case of devices incor porating, as an integral part, a medicinal substance whic h, if used \nseparately , would be considered to be a medicinal product derived from human blood or human plasma as \nrefer red to in Article 1(8) \nUpon compl eting the manufacture of each batch of devices that incor porat e, as an integral part, a medicinal \nsubstance which , if used separately , would be considered to be a medicinal product derived from human blood 5.5.2017 L 117/153 Official Jour nal of the European Union EN \n or human plasma as refer red to in the first subparagraph of Article 1(8), the manuf acturer shall inform the \nnotifi ed body of the release of the batch of devices and send it the official certificate concer ning the release of \nthe batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or \na laboratory designat ed for that purpose by a Member State in accordance with Article 114(2) of \nDirective 2001/83/EC. \nCHAPTER III \nADMINISTRA TIVE PROVISIONS \n7. The manufa cturer or, where the manuf acturer does not have a registered place of business in a Member State , its \nauthor ised representative shall, for a period ending no sooner than 10 years, and in the case of implantable \ndevices no sooner than 15 years, after the last device has been placed on the mark et, keep at the disposal of the \ncompet ent author ities: \n— the EU declaration of conf ormity , \n— the documentation refer red to in the fifth indent of Section 2.1 and in particular the data and records arising \nfrom the procedures referred to in point (c) of the second paragraph of Section 2.2, \n— information on the changes refer red to in Section 2.4, \n— the documentation refer red to in Section 4.2, and \n— the decisions and repor ts from the notified body as refer red to in this Annex. \n8. Each Member State shall require that the documentation referred to in Section 7 is kept at the disposal of \ncompet ent author ities for the period indicate d in that Section in case a manuf acturer , or its author ised represen \ntative, established within its territory goes bankr upt or ceases its business activity prior to the end of that period. 5.5.2017 L 117/154 Official Jour nal of the European Union EN",
"title": "ANNEX IX"
}
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REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
|
{
"articles": {
"Article 1": null,
"Article 10": null,
"Article 100": null,
"Article 101": null,
"Article 102": null,
"Article 103": null,
"Article 104": null,
"Article 105": null,
"Article 106": null,
"Article 107": null,
"Article 108": null,
"Article 109": null,
"Article 11": null,
"Article 110": null,
"Article 111": null,
"Article 112": null,
"Article 113": null,
"Article 114": null,
"Article 115": null,
"Article 116": {
"heading": "Separate delegated acts for different delegated powers",
"text": "Article 116 \nSeparate delegated acts for different delegated powers \nThe Commission shall adopt a separate delegat ed act in respect of each power delegat ed to it pursuant to this \nRegulation."
},
"Article 117": {
"heading": "Amendment to Directive 2001/83/EC [medicinal products]",
"text": "Article 117 \nAmendment to Directiv e 2001/83/EC \nIn Annex I to Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following: \n‘(12) Where, in accordance with the second subparagraph of Article 1(8) or the second subparagraph of Article 1(9) \nof Regulation (EU) 2017/745 of the European Parliament and of the Council (*), a product is governed by this \nDirective, the mark eting author isation dossier shall include, where available, the results of the assessment of \nthe conf ormity of the device part with the relevant general safety and performance requirements set out in \nAnnex I to that Regulation contained in the manufacturer's EU declaration of conf ormity or the relevant \ncertificate issued by a notifi ed body allowing the manuf acturer to affix a CE marking to the medical device. \nIf the dossier does not include the results of the conf ormity assessment referred to in the first subparagraph and \nwhere for the conf ormity assessment of the device, if used separately , the involvement of a notified body is \nrequired in accordance with Regulation (EU) 2017/745, the author ity shall require the applicant to provide an \nopinion on the conf ormity of the device part with the relevant general safety and performa nce requirements \nset out in Annex I to that Regulation issued by a notified body designat ed in accordance with that Regulation \nfor the type of device in question. \n(*)Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 Apr il 2017 on medical devices, \namending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and \nrepealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’. 5.5.2017 L 117/88 Official Jour nal of the European Union EN"
},
"Article 118": {
"heading": "Amendments to Regulation (EC) No 178/2002 [food]",
"text": "Article 118 \nAmendment to Regulation (EC) No 178/2002 \nIn the third paragraph of Article 2 of Regulation (EC) No 178/2002, the following point is added: \n‘(i) medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the \nCouncil (*). \n(*)Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 Apr il 2017 on medical devices, \namending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and \nrepealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).’."
},
"Article 119": {
"heading": "Amendments to Regulation (EC) No 1223/2009 [cosmetic products]",
"text": "Article 119 \nAmendment to Regulation (EC) No 1223/2009 \nIn Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added: \n‘4. The Commission may, at the request of a Member State or on its own initiative, adopt the necessar y measures \nto determine whether or not a specifi c product or group of products falls within the definit ion ‘cosmetic product’. \nThose measures shall be adopt ed in accordance with the regulat ory procedure refer red to in Article 32(2).’ ."
},
"Article 12": null,
"Article 120": {
"heading": "Transitional provisions",
"text": "Article 120 \nTransitional provisions \n1. From 26 May 2020, any publication of a notifi cation in respect of a notified body in accordance with \nDirectives 90/385/EEC and 93/42/EEC shall become void. \n2. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to 25 May \n2017 shall remain valid until the end of the period indicated on the certificate, excep t for certificates issued in \naccordance with Annex 4 to Directive 90/385/EEC or Annex IV to Directive 93/42/EEC whic h shall become void at the \nlatest on 27 May 2022. \nCertificates issued by notifi ed bodies in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 shall \nremain valid until the end of the period indicated on the certificate, which shall not exceed five years from its issuance. \nThey shall however become void at the latest on 27 May 2024. \n3. By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance \nwith Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only \nbe placed on the mark et or put into service provided that from the date of application of this Regulation it continues to \ncompl y with either of those Directives, and provided there are no significant chang es in the design and intende d \npurpose. However , the requirements of this Regulation relating to post-market surveillance, market surveillance, \nvigilance, registration of economic operat ors and of devices shall apply in place of the corresponding requirements in \nthose Directives. \nWithout prejudice to Chapt er IV and paragraph 1 of this Article, the notified body that issued the certificate refer red to \nin the first subparagraph shall continue to be responsible for the appropr iate surveillance in respect of all of the \napplicable requirements relating to the devices it has certified. \n4. Devices lawfully placed on the mark et pursuant to Directives 90/385/EEC and 93/42/EEC prior to 26 May 2020, \nand devices placed on the market from 26 May 2020 by virtue of a certificate as referred to in paragraph 2 of this \nArticle, may continue to be made available on the mark et or put into service until 27 May 2025. \n5. By way of derog ation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may \nbe placed on the mark et prior to 26 May 2020. \n6. By way of derogat ion from Directives 90/385/EEC and 93/42/EEC, conf ormity assessment bodies which comply \nwith this Regulation may be designate d and notifi ed prior 26 May 2020. Notif ied bodies whic h are designate d and \nnotified in accordance with this Regulation may carry out the conf ormity assessment procedures laid down in this \nRegulation and issue certificates in accordance with this Regulation prior to 26 May 2020. 5.5.2017 L 117/89 Official Jour nal of the European Union EN \n 7. As regar ds devices subject to the consultation procedure laid down in Article 54, paragraph 5 of this Article shall \napply provided that the necessar y appointments to the MDCG and exper t panels have been made. \n8. By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC and Article 14(1) \nand (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, manuf acturers, author ised representatives, \nimporters and notified bodies which , during the period starting on the later of the dates referred to point (d) of"
},
"Article 121": {
"heading": "Evaluation",
"text": "Article 121 \nEvaluation \nBy 27 May 2027, the Commission shall assess the application of this Regulation and produce an evaluation repor t on \nthe progress towards achi evement of the objectives contained herein including an assessment of the resources required \nto implement this Regulation. Special attention shall be given to the traceability of medical devices through the storag e, \npursuant to Article 27, of the UDI by economic operators, health institutions and health profes sionals."
},
"Article 122": {
"heading": "Repeal",
"text": "Article 122 \nRepeal \nWithout prejudice to Articles 120(3) and (4) of this Regulation, and without prejudice to the oblig ations of the \nMember States and manufacturers as regards vigilance and to the oblig ations of manufacturers as rega rds the making \navailable of documentation, under Directives 90/385/EEC and 93/42/EEC, those Directives are repealed with effect from \n26 May 2020, with the excep tion of: \n— Articles 8 and 10, points (b) and (c) of Article 10b(1), Article 10b(2) and Article 10b(3) of Directive 90/385/EEC, \nand the oblig ations relating to vigilance and clinical inve stigations provided for in the corresponding Annexes, which \nare repealed with effect from the later of the dates refer red to in point (d) of Article 123(3) of this Regulation; \n— Article 10a and point (a) of Article 10b(1) of Directive 90/385/EEC, and the oblig ations relating to registration of \ndevices and economic operators, and to certificate notifications, provided for in the corresponding Annexes, which \nare repealed with effect from 18 months after the later of the date s refer red to in point (d) of Article 123(3) of this \nRegulation; \n— Article 10, points (c) and (d) of Article 14a(1), Article 14a(2), Article 14a(3) and Article 15 of Directive 93/42/EEC, \nand the oblig ations relating to vigilance and clinical inve stigations provided for in the corresponding Annexes, which \nare repealed with effect from the later of the dates refer red to in point (d) of Article 123(3) of this Regulation; and 5.5.2017 L 117/90 Official Jour nal of the European Union EN \n — Article 14(1) and (2) and points (a) and (b) of Article 14a(1) of Directive 93/42/EEC, and the oblig ations relating to \nregistration of devices and economic operat ors, and to certificate notifications, provided for in the corresponding \nAnnex es, whic h are repealed with effect from 18 months after the later of the dates refer red to in point (d) of"
},
"Article 123": {
"heading": "Entry into force and date of application",
"text": "Article 123 \nEntr y into force and date of application \n1. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of \nthe European Union. \n2. It shall apply from 26 May 2020. \n3. By way of deroga tion from paragraph 2: \n(a) Articles 35 to 50 shall apply from 26 November 2017. However , from that date until 26 May 2020, the oblig ations \non notified bodies pursuant to Articles 35 to 50 shall apply only to those bodies which submit an application for \ndesignation in accordance with Article 38; \n(b) Articles 101 and 103 shall apply from 26 November 2017; \n(c) Article 102 shall apply from 26 May 2018; \n(d) without prejudice to the oblig ations on the Commission pursuant to Article 34, where, due to circumstances that \ncould not reasonably have been foreseen when draf ting the plan referred to in Article 34(1), Eudamed is not fully \nfunctional on 26 May 2020, the oblig ations and requirements that relat e to Eudamed shall apply from the date \ncorresponding to six months after the date of publication of the notice referred to in Article 34(3). The provisions \nrefer red to in the preceding senten ce are: \n— Article 29, \n— Article 31, \n— Article 32, \n— Article 33(4), \n— the second sentence of Article 40(2), \n— Article 42(10), \n— Article 43(2), \n— the second subparagraph of Article 44(12), \n— points (d) and (e) of Article 46(7), \n— Article 53(2), \n— Article 54(3), \n— Article 55(1), \n— Articles 70 to 77, \n— paragraphs 1 to 13 of Article 78, \n— Articles 79 to 82, \n— Article 86(2), \n— Articles 87 and 88, \n— Article 89(5) and (7), and the third subparagraph of Article 89(8), 5.5.2017 L 117/91 Official Jour nal of the European Union EN \n — Article 90, \n— Article 93(4), (7) and (8), \n— Article 95(2) and (4), \n— the last sentence of Article 97(2), \n— Article 99(4), \n— the second sentence of the first subparagraph of Article 120(3). \nUntil Eudamed is fully functional, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall \ncontinue to apply for the purpose of meeting the obligations laid down in the provisions listed in the first \nparagraph of this point regarding exchange of information including, and in particular , information regarding \nvigilance repor ting, clinical investigations, registration of devices and economic operators, and certificate notifi \ncations. \n(e) Article 29(4) and Article 56(5) shall apply from 18 months after the later of the dates referred to in point (d); \n(f) for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For class IIa and \nclass IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices Article 27(4) shall apply from \n26 May 2025; \n(g) for reusable devices that shall bear the UDI carrier on the device itself, Article 27(4) shall apply from two years after \nthe date refer red to in point (f) of this paragraph for the respective class of devices in that point ; \n(h) The procedure set out in Article 78 shall apply from 26 May 2027, without prejudice to Article 78(14); \n(i) Article 120(12) shall apply from 26 May 2019. \nThis Regulation shall be binding in its entirety and directly applicable in all Member State s. \nDone at Strasbourg, 5 Apr il 2017. \nFor the European Parliament \nThe President \nA. TAJANI For the Council \nThe President \nI. BOR G 5.5.2017 L 117/92 Official Jour nal of the European Union EN \n ANNEXES \nI General safety and perf ormance requirements \nII Techn ical documentation \nIII Techn ical documentation on post-market surveillance \nIV EU declaration of conf ormity \nV CE marking of conf ormity \nVI Information to be submitted upon the registration of devices and economic operators in accordance with \nArticles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in \naccordance with Articles 28 and 29;and the UDI system \nVII Requirements to be met by notifi ed bodies \nVIII Classification rules \nIX Conf ormity assessment based on a quality management system and assessment of the technical documentation \nX Conf ormity assessment based on type examination \nXI Conf ormity assessment based on product conf ormity verification \nXII Certificates issued by a notifi ed body \nXIII Procedure for custom -made devices \nXIV Clinical evaluation and post-market clinical follow-up \nXV Clinical investigations \nXVI List of groups of products without an intended medical purpose refer red to in Article 1(2) \nXVII Correlation table 5.5.2017 L 117/93 Official Jour nal of the European Union EN \n ANNEX I \nGENERAL SAFE TY AND PERFORMANCE REQUIREMENTS \nCHAPTER I \nGENERAL REQUIREMENTS \n1. Devices shall achieve the performa nce intende d by their manufacturer and shall be designed and manufactured \nin such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be \nsafe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and \nhealth of users or, where applicable, other persons, provided that any risks whic h may be associated with their \nuse constitute accept able risks when weighed against the benefi ts to the patient and are compati ble with a high \nlevel of protection of health and safety , taking into account the generally ackn owledged state of the art. \n2. The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible \nwithout adversely affect ing the benefit-r isk ratio. \n3. Manufactur ers shall establish, implement, document and maintain a risk management system. \nRisk management shall be underst ood as a continuous iterative process throughout the entire lifecy cle of \na device, requir ing regular systematic updating. In carrying out risk management manufacturers shall: \n(a) establish and document a risk management plan for each device; \n(b) identify and analyse the kno wn and foreseeable hazards associated with each device; \n(c) estimate and evaluate the risks associated with, and occur ring during, the intended use and during \nreasonably foreseeable misuse; \n(d) eliminate or control the risks refer red to in point (c) in accordance with the requirements of Section 4; \n(e) evaluate the impact of information from the production phase and, in particular , from the post-market \nsurveillance system, on hazards and the frequency of occur rence thereof, on estimates of their associated \nrisks, as well as on the overall risk, benefit-r isk ratio and risk accept ability ; and \n(f) based on the evaluation of the impact of the information referred to in point (e), if necessar y amend \ncontrol measures in line with the requirements of Section 4. \n4. Risk control measures adopt ed by manuf acturers for the design and manufacture of the devices shall conf orm \nto safety principles, taking account of the generally ackn owledged state of the art. To reduce risks, Manufac \nturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk \nis judged acceptab le. In selecting the most appropr iate solutions, manuf acturers shall, in the following order of \npriority: \n(a) eliminate or reduce risks as far as possible through safe design and manufa cture; \n(b) where appropr iate, take adequate prot ection measures, including alarms if necessar y, in relation to risks \nthat cannot be eliminated; and \n(c) provide information for safety (war nings/precautions/contra-indications) and, where appropr iate, training to \nusers. \nManufactur ers shall inform users of any residual risks. \n5. In eliminating or reducing risks relat ed to use error, the manufacturer shall: \n(a) reduce as far as possible the risks related to the ergonomic features of the device and the environment in \nwhich the device is intended to be used (design for patient safety) , and \n(b) give consideration to the technical kno wledge, exper ience, education, training and use environment, where \napplicable, and the medical and physical conditions of intended users (design for lay, professional, disabled \nor other users). 5.5.2017 L 117/94 Official Jour nal of the European Union EN \n 6. The charact eristics and performa nce of a device shall not be adversely affected to such a degree that the health \nor safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime \nof the device, as indicate d by the manufa cturer , when the device is subjected to the stresses whic h can occur \nduring normal conditions of use and has been properly maintained in accordance with the manufact urer's \ninstr uctions. \n7. Devices shall be designed, manufactured and packag ed in such a way that their charact eristics and performa nce \nduring their intende d use are not adversely affect ed during transpor t and storage, for example, through \nfluctuations of temperature and humidity , taking account of the instr uctions and information provided by the \nmanufacturer . \n8. All kno wn and foreseeable risks, and any undesirable side-eff ects, shall be minimised and be acceptable when \nweighed against the evaluated benefi ts to the patient and/or user arising from the achi eved performa nce of the \ndevice during normal conditions of use. \n9. For the devices referred to in Annex XVI, the general safet y requirements set out in Sections 1 and 8 shall be \nunderstood to mean that the device, when used under the conditions and for the purposes intended, does not \npresent a risk at all or presents a risk that is no more than the maximum acceptable risk relat ed to the \nproduct's use whic h is consistent with a high level of prot ection for the safety and health of persons. \nCHA PTER II \nREQUIREMENTS REGARDING DESIGN AND MANUF ACTURE \n10. Chemical, physical and biological proper ties \n10.1. Devices shall be designed and manuf actured in such a way as to ensure that the characteri stics and \nperforma nce requirements refer red to in Chapt er I are fulfilled. Particular attention shall be paid to: \n(a) the choice of mater ials and substances used, particularly as regar ds toxicity and, where relevant, \nflammability ; \n(b) the compat ibility between the mat erials and substances used and biological tissues, cells and body fluids, \ntaking account of the intended purpose of the device and, where relevant, absor ption, distr ibution, \nmetabolism and excretion; \n(c) the compatibility between the differ ent parts of a device which consists of more than one implantable part; \n(d) the impact of processes on mat erial proper ties; \n(e) where appropr iate, the results of biophysical or modelling research the validity of whic h has been \ndemonstrated beforehand; \n(f) the mechanical proper ties of the mate rials used, reflecting, where appropr iate, matters such as strength, \nductility , fracture resistance, wear resistance and fatigue resistance; \n(g) surface proper ties; and \n(h) the conf irmation that the device meets any defined chemical and/or physical specifi cations. \n10.2. Devices shall be designed, manufact ured and packag ed in such a way as to minimise the risk posed by \ncontaminants and residues to patients, taking account of the intended purpose of the device, and to the \npersons involved in the transpor t, storag e and use of the devices. Particular attention shall be paid to tissues \nexposed to those contaminants and residues and to the duration and frequency of exposure. \n10.3. Devices shall be designed and manufa ctured in such a way that they can be used safely with the mat erials and \nsubstances, including gases, with which they enter into contact during their intended use; if the devices are \nintended to administer medicinal products they shall be designed and manufactured in such a way as to be \ncompatib le with the medicinal products concer ned in accordance with the provisions and restr ictions \ngoverning those medicinal products and that the performa nce of both the medicinal products and of the \ndevices is maintained in accordance with their respective indications and intended use. 5.5.2017 L 117/95 Official Jour nal of the European Union EN \n 10.4. Substances \n10.4.1. Design and manufacture of devices \nDevices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by \nsubstances or particles, including wear debr is, degradation products and processing residues, that may be \nreleased from the device. \nDevices, or those parts thereof or those mat erials used therein that: \n— are invasive and come into direct contact with the human body , \n— (re)administ er medicines, body liquids or other substances, including gases, to/from the body , or \n— transpor t or store such medicines, body fluids or substances, including gases, to be (re)administered to the \nbody , \nshall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) \nwhere justified pursuant to Section 10.4.2: \n(a) substances which are carcinog enic, mutagenic or toxic to reproduction (‘CMR’), of categor y 1A or 1B, in \naccordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of \nthe Council (1), or \n(b) substances having endocr ine-disr upting proper ties for whic h there is scientifi c evidence of probable serious \neffects to human health and whic h are identif ied either in accordance with the procedure set out in"
},
"Article 13": null,
"Article 14": null,
"Article 15": null,
"Article 16": null,
"Article 17": null,
"Article 18": null,
"Article 19": null,
"Article 2": null,
"Article 20": null,
"Article 21": null,
"Article 22": null,
"Article 23": null,
"Article 24": null,
"Article 25": null,
"Article 26": null,
"Article 27": null,
"Article 28": null,
"Article 29": null,
"Article 3": null,
"Article 30": null,
"Article 31": null,
"Article 32": null,
"Article 33": null,
"Article 34": null,
"Article 35": null,
"Article 36": null,
"Article 37": null,
"Article 38": null,
"Article 39": null,
"Article 4": null,
"Article 40": null,
"Article 41": null,
"Article 42": null,
"Article 43": null,
"Article 44": null,
"Article 45": null,
"Article 46": null,
"Article 47": null,
"Article 48": null,
"Article 49": null,
"Article 5": null,
"Article 50": null,
"Article 51": null,
"Article 52": null,
"Article 53": null,
"Article 54": null,
"Article 55": null,
"Article 56": null,
"Article 57": null,
"Article 58": null,
"Article 59": null,
"Article 6": null,
"Article 60": null,
"Article 61": null,
"Article 62": null,
"Article 63": null,
"Article 64": null,
"Article 65": null,
"Article 66": null,
"Article 67": null,
"Article 68": null,
"Article 69": null,
"Article 7": null,
"Article 70": null,
"Article 71": null,
"Article 72": null,
"Article 73": null,
"Article 74": null,
"Article 75": null,
"Article 76": null,
"Article 77": null,
"Article 78": null,
"Article 79": null,
"Article 8": null,
"Article 80": null,
"Article 81": null,
"Article 82": null,
"Article 83": null,
"Article 84": null,
"Article 85": null,
"Article 86": null,
"Article 87": null,
"Article 88": null,
"Article 89": null,
"Article 9": null,
"Article 90": null,
"Article 91": null,
"Article 92": null,
"Article 93": null,
"Article 94": null,
"Article 95": null,
"Article 96": null,
"Article 97": null,
"Article 98": null,
"Article 99": null
},
"title": "Final provisions"
}
|
{
"text": "CONFORMIT Y ASSESSMENT BASED ON TYPE-EXAMINA TION \n1. EU type-examination is the procedure whereby a notified body ascer tains and certifies that a device, including its \ntechnical documentation and relevant life cycle processes and a corresponding representative sample of the device \nproduction envisaged, fulfils the relevant provisions of this Regulation. \n2. Application \nThe manufacturer shall lodge an application for assessment with a notified body . The application shall include: \n— the name of the manuf acturer and address of the register ed place of business of the manufacturer and, if the \napplication is lodged by the author ised representative, the name of the author ised representative and the \naddress of its registere d place of business, \n— the technical documentation referred to in Annexes II and III. The applicant shall make a representative sample \nof the device production envisag ed (‘type’ ) available to the notified body . The notifi ed body may request other \nsamples as necessar y, and \n— a written declaration that no application has been lodg ed with any other notified body for the same type, or \ninformation about any previous application for the same type that was refused by another notified body or was \nwithdrawn by the manuf acturer or its author ised representative before that other notified body made its final \nassessment. \n3. Assessment \nThe notifi ed body shall: \n(a) examine the application by using staff with proven kno wledge and exper ience regarding the technology \nconcer ned and its clinical application. The notified body may require the application to be compl eted by having \nfurther tests carried out or requesting further evidence to be provided to allow assessment of conf ormity with \nthe relevant requirements of this Regulation. The notifi ed body shall carry out adequate physical or laboratory \ntests in relation to the device or request the manuf acturer to carry out such tests; \n(b) examine and assess the technical documentation for conf ormity with the requirements of this Regulation that \nare applicable to the device and verify that the type has been manufactured in conf ormity with that documen \ntation; it shall also record the items designed in conf ormity with the applicable standards refer red to in \nArticle 8 or with applicable CS, and record the items not designed on the basis of the relevant standards \nreferred to in Article 8 or of the relevant CS; \n(c) review the clinical evidence presented by the manuf acturer in the clinical evaluation repor t in accordance with \nSection 4 of Annex XIV. The notified body shall emplo y device reviewers with sufficient clinical exper tise and, \nif necessar y, use external clinical exper ts with direct and current exper ience relating to the device in question or \nto the clinical condition in whic h it is utilised, for the purposes of that review ; \n(d) in circumstances in which the clinical evidence is based partly or totally on data from devices whic h are \nclaimed to be similar or equivalent to the device under assessment, assess the suitability of using such data, \ntaking into account factors such as new indications and inno vation. The notified body shall clearly document \nits conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating \nconf ormity ; \n(e) clearly document the outcome of its assessment in a pre-clinical and clinical evaluation assessment repor t as \npart of the EU type examination repor t referred to in point (i); \n(f) carry out or arrang e for the appropr iate assessments and the physical or laboratory tests necessar y to verify \nwhether the solutions adopt ed by the manufact urer meet the general safet y and performa nce requirements laid \ndown in this Regulation, in the event that the standards refer red to in Article 8 or the CS have not been \napplied. Where the device has to be connected to another device or devices in order to operat e as intended, \nproof shall be provided that it conf orms to the general safet y and performa nce requirements when connect ed \nto any such device or devices having the charact eristics specifi ed by the manufacturer; 5.5.2017 L 117/155 Official Jour nal of the European Union EN \n (g) carry out or arrang e for the appropr iate assessments and the physical or laboratory tests necessar y to verify \nwhether , in the event that the manufacturer has chosen to apply the relevant harmonised standards, those \nstandards have actually been applied; \n(h) agree with the applicant on the place where the necessar y assessments and tests are to be carried out; and \n(i) draw up an EU type-examination repor t on the results of the assessments and tests carried out under points (a) \nto (g). \n4. Certificate \nIf the type conf orms to this Regulation, the notified body shall issue an EU type-examination certificate. The \ncertificate shall contain the name and address of the manufacturer , the conclusions of the type examination \nassessment, the conditions of the certificate's validity and the data needed for identification of the type appro ved. \nThe certificate shall be drawn up in accordance with Annex XII. The relevant parts of the documentation shall be \nannex ed to the certificate and a copy kept by the notified body . \n5. Change s to the type \n5.1. The applicant shall inform the notifi ed body whic h issued the EU type-examination certificate of any planned \nchange to the appro ved type or of its intended purpose and conditions of use. \n5.2. Change s to the appro ved device including limitations of its intended purpose and conditions of use shall require \nappro val from the notifi ed body which issued the EU type-examination certificate where such chang es may affect \nconf ormity with the general safety and performa nce requirements or with the conditions prescr ibed for use of the \nproduct. The notified body shall examine the planned change s, notify the manuf acturer of its decision and provide \nhim with a supplement to the EU type-examination repor t. The appro val of any change to the appro ved type shall \ntake the form of a supplement to the EU type-examination certificate. \n5.3. Change s to the intended purpose and conditions of use of the appro ved device, with the exce ption of limitations of \nthe intended purpose and conditions of use, shall necessitate a new application for a conf ormity assessment. \n6. Specific additional procedures \nSection 5 of Annex IX shall apply with the proviso that any reference to an EU technical documentation \nassessment certificate shall be understood as a reference to an EU type-examination certificate. \n7. Administrative provisions \nThe manuf acturer or, where the manufacturer does not have a registere d place of business in a Member State, its \nauthor ised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices \nno sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the compet ent \nauthor ities: \n— the documentation referred to in the second indent of Section 2, \n— information on the changes refer red to in Section 5, and \n— copies of EU type-examination certificates, scientific opinions and repor ts and their additions/supplements. \nSection 8 of Annex IX shall apply . 5.5.2017 L 117/156 Official Jour nal of the European Union EN",
"title": "ANNEX X"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
| null |
{
"text": "CONFORM ITY ASSESSMENT BASED ON PRODUCT CONFORMIT Y VERIFIC ATION \n1. The objective of the conf ormity assessment based on product conf ormity verification is to ensure that devices \nconf orm to the type for whic h an EU type-examination certificate has been issued, and that they meet the \nprovisions of this Regulation which apply to them. \n2. Where an EU type-examination certificate has been issued in accordance with Annex X, the manufa cturer may \neither apply the procedure set out in Part A (production quality assurance) or the procedure set out in Part B \n(product verification) of this Annex. \n3. By way of derogation from Sections 1 and 2 above, the procedures in this Annex coupled with the drawing up \nof technical documentation as set out in Annex es II and III may also be applied by manufact urers of class IIa \ndevices. \nPART A \nPRODUCTION QUALIT Y ASSURANCE \n4. The manufacturer shall ensure that the quality manag ement system appro ved for the manufacture of the devices \nconcer ned is implemented, shall carry out a final verification, as specif ied in Section 6, and shall be subject to \nthe surveillance refer red to in Section 7. \n5. When the manuf acturer fulfils the oblig ations laid down in Section 4, it shall draw up and keep an EU \ndeclaration of conf ormity in accordance with Article 19 and Annex IV for the device covered by the conf ormity \nassessment procedure. By issuing an EU declaration of conf ormity , the manuf acturer shall be deemed to ensure \nand to declare that the device concer ned conf orms to the type descr ibed in the EU type-examination certificate \nand meets the requirements of this Regulation whic h apply to the device. \n6. Quality manage ment system \n6.1. The manuf acturer shall lodg e an application for assessment of its quality manag ement system with a notifi ed \nbody . The application shall include: \n— all elements liste d in Section 2.1 of Annex IX, \n— the technical documentation refer red to in Annexes II and III for the types appro ved, and \n— a copy of the EU type-examination certificates refer red to in Section 4 of Annex X; if the EU type- \nexamination certificates have been issued by the same notified body with whic h the application is lodge d, \na reference to the technical documentation and its updat es and the certificates issued shall also be included in \nthe application. \n6.2. Implementation of the quality manag ement system shall be such as to ensure that there is compl iance with the \ntype descr ibed in the EU type-examination certificate and with the provisions of this Regulation which apply to \nthe devices at each stage. All the elements, requirements and provisions adopt ed by the manuf acturer for its \nquality management system shall be documented in a systematic and orderly manner in the form of a quality \nmanual and written policies and procedures, such as quality programmes, quality plans and quality records. \nThat documentation shall, in particular , include an adequate descr iption of all elements listed in points (a), (b), (d) \nand (e) of Section 2.2 of Annex IX. \n6.3. The first and second paragraph of Section 2.3 of Annex IX shall apply . \nIf the quality management syste m is such that it ensures that the devices conf orm to the type descr ibed in the EU \ntype-examination certificate and that it conf orms to the relevant provisions of this Regulation, the notified body \nshall issue an EU quality assurance certificate. The notified body shall notify the manufa cturer of its decision to \nissue the certificate. That decision shall contain the conclusions of the notified body's audit and a reasoned \nassessment. 5.5.2017 L 117/157 Official Jour nal of the European Union EN \n 6.4. Section 2.4 of Annex IX shall apply . \n7. Surveillance \nSection 3.1, the first, second and fourth indents of Section 3.2, Sections 3.3, 3.4, 3.6 and 3.7 of Annex IX shall \napply . \nIn the case of class III devices, surveillance shall also include a check that the quantities of produced or \npurchased raw mate rial or crucial compo nents appro ved for the type and correspond to the quantities of \nfinished devices. \n8. Batch verification in the case of devices incor porating, as an integral part, a medicinal substance whic h, if used \nseparately , would be considered to be a medicinal product derived from human blood or human plasma refer red \nto in Article 1(8). \nUpon compl eting the manufacture of each batch of devices that incor porat e, as an integral part, a medicinal \nsubstance which , if used separately , would be considered to be a medicinal product derived from human blood \nor human plasma referred to in the first subparagraph of Article 1(8), the manufacturer shall inform the notifi ed \nbody of the release of the batch of devices and send it the official certificate concer ning the release of the batch \nof human blood or plasma derivative used in the device, issued by a Member State laboratory or a laborat ory \ndesignated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC. \n9. Administrative provisions \nThe manufa cturer or, where the manuf acturer does not have a registered place of business in a Member State , its \nauthor ised representative shall, for a period ending no sooner than 10 years, and in the case of implantable \ndevices no sooner than 15 years, after the last device has been placed on the mark et, keep at the disposal of the \ncompet ent author ities: \n— the EU declaration of conf ormity , \n— the documentation refer red to in the fifth indent of Section 2.1 of Annex IX, \n— the documentation refer red to in the eighth indent of Section 2.1 of Annex IX, including the EU type- \nexamination certificate refer red to in Annex X, \n— information on the changes refer red to in Section 2.4 of Annex IX, and \n— the decisions and repor ts from the notified body as refer red to in Sections 2.3, 3.3 and 3.4 of Annex IX. \nSection 8 of Annex IX shall apply . \n10. Application to class IIa devices \n10.1. By way of deroga tion from Section 5, by virtue of the EU declaration of conf ormity the manufacturer shall be \ndeemed to ensure and to declare that the class IIa devices in question are manuf actured in conf ormity with the \ntechnical documentation refer red to in Annex es II and III and meet the requirements of this Regulation which \napply to them. \n10.2. For class IIa devices the notified body shall assess, as part of the assessment refer red to in Section 6.3, whether \nthe technical documentation as refer red to in Annex es II and III for the devices selected on a representative basis \nis compliant with this Regulation. \nIn choosing a representative sam ple or samples of devices, the notified body shall take into account the novelty \nof the technology , similar ities in design, technology , manufactur ing and sterilisation methods, the intended use \nand the results of any previous relevant assessments (e.g. with regard to physical, chemical, biological or clinical \nproper ties) that have been carried out in accordance with this Regulation. The notifi ed body shall document its \nrationale for the sample or samp les of devices take n. 5.5.2017 L 117/158 Official Jour nal of the European Union EN \n 10.3. Where the assessment under Section 10.2. confir ms that the class IIa devices in question conf orm to the \ntechnical documentation refer red to in Annex es II and III and meet the requirements of this Regulation which \napply to them, the notified body shall issue a certificate pursuant to this Part of this Annex. \n10.4. Samples additional to those taken for the initial conf ormity assessment of devices shall be assessed by the \nnotifi ed body as part of the surveillance assessment referred to in Section 7. \n10.5. By way of derogation from Section 6, the manufacturer or its author ised representative shall, for a period ending \nno sooner than 10 years after the last device has been placed on the mark et, keep at the disposal of the \ncompet ent author ities: \n— the EU declaration of conf ormity , \n— the technical documentation refer red to in Annexes II and III, and \n— the certificate refer red to in Section 10.3. \nSection 8 of Annex IX shall apply . \nPART B \nPRODUCT VERIFIC ATION \n11. Product verification shall be underst ood to be the procedure whereby after examination of ever y manuf actured \ndevice, the manufacturer , by issuing an EU declaration of conf ormity in accordance with Article 19 and",
"title": "ANNEX XI"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
| null |
{
"text": "CERT IFIC ATES ISSUED BY A NOTIFIED BOD Y \nCHAPTER I \nGENERAL REQUIREMENTS \n1. Certificates shall be drawn up in one of the official language s of the Union. \n2. Each certificate shall refer to only one conf ormity assessment procedure. \n3. Certificates shall only be issued to one manufacturer . The name and address of the manufact urer included in the \ncertificate shall be the same as that registe red in the electronic system referred to in Article 30. \n4. The scope of the certificates shall unambiguously identify the device or devices covered: \n(a) EU technical documentation assessment certificates, EU type-examination certificates and EU product verification \ncertificates shall include a clear identif ication, including the name, model and type, of the device or devices, the \nintende d purpose, as included by the manufacturer in the instr uctions for use and in relation to which the device \nhas been assessed in the conf ormity assessment procedure, risk classificat ion and the Basic UDI-DI as referred to \nin Article 27(6); \n(b) EU quality manage ment syste m certificates and EU quality assurance certificates shall include the identif ication of \nthe devices or groups of devices, the risk classif ication, and, for class IIb devices, the intende d purpose. \n5. The notified body shall be able to demonstrate on request, which (individual) devices are covered by the certificate. \nThe notifi ed body shall set up a syste m that enables the determination of the devices, including their classif ication, \ncovered by the certificate. \n6. Certificates shall contain, if applicable, a note that, for the placing on the market of the device or devices it covers, \nanother certificate issued in accordance with this Regulation is required. \n7. EU quality management system certificates and EU quality assurance certificates for class I devices for which the \ninvolvement of a notified body is required pursuant to Article 52(7) shall include a statement that the audit by the \nnotified body of the quality management system was limited to the aspects required under that paragraph. \n8. Where a certificate is supplemented, modified or re-issued, the new certificate shall contain a reference to the \npreceding certificate and its date of issue with identif ication of the change s. \nCHA PTER II \nMINIMUM CONTE NT OF THE CERT IFIC ATES \n1. name, address and identif ication number of the notified body ; \n2. name and address of the manufacturer and, if applicable, of the author ised representative; \n3. unique number identifying the certificate; \n4. if already issued, the SRN of the manufacturer refer red to in to Article 31(2); \n5. date of issue; \n6. date of expir y; \n7. data needed for the unambiguous identif ication of the device or devices where applicable as specified in Section 4 \nof Part I; 5.5.2017 L 117/161 Official Jour nal of the European Union EN \n 8. if applicable, reference to any previous certificate as specif ied in Section 8 of Chapt er I; \n9. referen ce to this Regulation and the relevant Annex in accordance with which the conf ormity assessment has been \ncarried out; \n10. examinations and tests performe d, e.g. referen ce to relevant CS, harmonised standards, test repor ts and audit \nrepor t(s); \n11. if applicable, reference to the relevant parts of the technical documentation or other certificates required for the \nplacing on the mark et of the device or devices covered; \n12. if applicable, information about the surveillance by the notifi ed body ; \n13. conclusions of the notified body's conf ormity assessment with regar d to the relevant Annex; \n14. conditions for or limitations to the validity of the certificate; \n15. legally binding signature of the notifi ed body in accordance with the applicable national law. 5.5.2017 L 117/162 Official Jour nal of the European Union EN",
"title": "ANNEX XII"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
| null |
{
"text": "PROCEDURE FOR CUSTOM-MADE DEVICES \n1. For custom-made devices, the manufacturer or its author ised representative shall draw up a statement containing all \nof the following information: \n— the name and address of the manuf acturer , and of all manuf actur ing sites, \n— if applicable, the name and address of the author ised representative, \n— data allowing identif ication of the device in question, \n— a state ment that the device is intended for excl usive use by a particular patient or user , identif ied by name, an \nacronym or a numer ical code, \n— the name of the person who made out the prescr iption and who is author ised by national law by virtue of their \nprofessional qualifications to do so, and, where applicable, the name of the health institution concer ned, \n— the specific characteri stics of the product as indicated by the prescr iption, \n— a statement that the device in question conf orms to the general safety and performa nce requirements set out in",
"title": "ANNEX XIII"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
| null |
{
"text": "CLINIC AL EVALU ATION AND POST -MARKET CLINIC AL FOLLO W-UP \nPART A \nCLINIC AL EVALU ATION \n1. To plan, continuously conduct and document a clinical evaluation, manuf acturers shall: \n(a) establish and update a clinical evaluation plan, which shall include at least: \n— an identif ication of the general safety and performa nce requirements that require suppor t from relevant \nclinical data; \n— a specification of the intended purpose of the device; \n— a clear specific ation of intende d target groups with clear indications and contra-indications; \n— a detailed descr iption of intended clinical benefi ts to patients with relevant and specified clinical outcome \nparameter s; \n— a specific ation of methods to be used for examination of qualitative and quantitative aspects of clinical \nsafety with clear reference to the determination of residual risks and side-eff ects; \n— an indicative list and specifi cation of parameter s to be used to determine, based on the state of the art in \nmedicine, the acceptab ility of the benefi t-risk ratio for the various indications and for the intended purpose \nor purposes of the device; \n— an indication how benefi t-risk issues relating to specifi c compo nents such as use of phar maceutical, non- \nviable animal or human tissues, are to be addressed; and \n— a clinical development plan indicating progression from exploratory inve stigations, such as first-in-man \nstudies, feasibility and pilot studies, to confir matory investigations, such as pivotal clinical investig ations, \nand a PMCF as referred to in Part B of this Annex with an indication of mileston es and a descr iption of \npoten tial acceptance criteria; \n(b) identify available clinical data relevant to the device and its intended purpose and any gaps in clinical evidence \nthrough a systematic scientific literature review ; \n(c) appraise all relevant clinical data by evaluating their suitability for establishing the safety and perf ormance of \nthe device; \n(d) generat e, through properly designed clinical investigations in accordance with the clinical development plan, \nany new or additional clinical data necessar y to address outstanding issues; and \n(e) analyse all relevant clinical data in order to reac h conclusions about the safety and clinical performa nce of the \ndevice including its clinical benefi ts. \n2. The clinical evaluation shall be thorough and objective, and take into account both favourable and unfa vourable \ndata. Its depth and exte nt shall be propor tionate and appropr iate to the nature, classification, intended purpose \nand risks of the device in question, as well as to the manufacturer 's claims in respect of the device. \n3. A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in \nquestion can be demonstrate d. The following technical, biological and clinical charact eristics shall be take n into \nconsideration for the demonstration of equivalence: \n— Technical: the device is of similar design; is used under similar conditions of use; has similar specifications and \nproper ties including physicoche mical proper ties such as intensity of energy , tensile strength, viscosity , surface \ncharact eristics, wave length and software algor ithms; uses similar deplo yment methods, where relevant ; has \nsimilar principles of operation and critical performance requirements; \n— Biological: the device uses the same mate rials or substances in contact with the same human tissues or body \nfluids for a similar kind and duration of contact and similar release charact eristics of substances, including \ndegradation products and leachables ; 5.5.2017 L 117/164 Official Jour nal of the European Union EN \n — Clinical: the device is used for the same clinical condition or purpose, including similar sever ity and stage of \ndisease, at the same site in the body , in a similar population, including as regards age, anatom y and physiology ; \nhas the same kind of user; has similar relevant critical performance in view of the expected clinical effect for \na specifi c intende d purpose. \nThe character istics listed in the first paragraph shall be similar to the extent that there would be no clinically \nsignif icant differ ence in the safety and clinical performa nce of the device. Considerations of equivalence shall be \nbased on proper scientifi c justification. It shall be clearly demonstrated that manuf acturers have sufficient levels of \naccess to the data relating to devices with whic h they are claiming equivalence in order to justify their claims of \nequivalence. \n4. The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in \na clinical evaluation repor t whic h shall suppor t the assessment of the conf ormity of the device. \nThe clinical evidence together with non-clinical data generated from non-clinical testing methods and other \nrelevant documentation shall allow the manufacturer to demonstrate conf ormity with the general safety and \nperforma nce requirements and shall be part of the technical documentation for the device in question. \nBoth favour able and unfa vourable data considered in the clinical evaluation shall be included in the technical \ndocumentation. \nPART B \nPOST -MARKET CLINIC AL FOLL OW-UP \n5. PMCF shall be underst ood to be a continuous process that updat es the clinical evaluation refer red to in Article 61 \nand Part A of this Annex and shall be addressed in the manufa cturer's post-market surveillance plan. When \nconducting PMCF , the manufacturer shall proactively collect and evaluate clinical data from the use in or on \nhumans of a device which bears the CE marking and is placed on the mark et or put into service within its \nintended purpose as referred to in the relevant conf ormity assessment procedure, with the aim of confir ming the \nsafety and performa nce throughout the expect ed lifetime of the device, of ensur ing the continued acceptabil ity of \nidentif ied risks and of detecting emerging risks on the basis of factual evidence. \n6. PMCF shall be performe d pursuant to a documented method laid down in a PMCF plan. \n6.1. The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data \nwith the aim of: \n(a) conf irming the safety and performa nce of the device throughout its expect ed lifetime, \n(b) identifying previously unkno wn side-effects and monitoring the identif ied side-effects and contraindications, \n(c) identifying and analysing emergent risks on the basis of factual evidence, \n(d) ensur ing the continued acceptabil ity of the benefit-r isk ratio refer red to in Sections 1 and 9 of Annex I, and \n(e) identifying possible systema tic misuse or off-label use of the device, with a view to verifying that the intende d \npurpose is correct. \n6.2. The PMCF plan shall include at least : \n(a) the general methods and procedures of the PMCF to be applied, such as gatheri ng of clinical exper ience gained, \nfeedback from users, screening of scientifi c literature and of other sources of clinical data; \n(b) the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF \nstudies; \n(c) a rationale for the appropr iateness of the methods and procedures referred to in points (a) and (b); \n(d) a reference to the relevant parts of the clinical evaluation repor t referred to in Section 4 and to the risk \nmanagemen t refer red to in Section 3 of Annex I; 5.5.2017 L 117/165 Official Jour nal of the European Union EN \n (e) the specifi c objectives to be addressed by the PMCF; \n(f) an evaluation of the clinical data relating to equivalent or similar devices; \n(g) referen ce to any relevant CS, harmonised standards when used by the manufacturer , and relevant guidance on \nPMCF; and \n(h) a detailed and adequately justified time sched ule for PMCF activities (e.g. analysis of PMCF data and repor ting) \nto be under taken by the manufacturer . \n7. The manufa cturer shall analyse the findings of the PMCF and document the results in a PMCF evaluation repor t \nthat shall be part of the clinical evaluation repor t and the technical documentation. \n8. The conclusions of the PMCF evaluation repor t shall be take n into account for the clinical evaluation referred to in \nArticle 61 and Part A of this Annex and in the risk manag ement refer red to in Section 3 of Annex I. If, through \nthe PMCF , the need for preventive and/or corrective measures has been identified, the manuf acturer shall \nimp lement them. 5.5.2017 L 117/166 Official Jour nal of the European Union EN",
"title": "ANNEX XIV"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
| null |
{
"text": "CLINIC AL INVESTIGA TIONS \nCHAPTER I \nGENERAL REQUIREMENTS \n1. Ethical principles \nEach step in the clinical investigat ion, from the initial consideration of the need for and justification of the study \nto the publication of the results, shall be carried out in accordance with recognised ethical principles. \n2. Methods \n2.1. Clinical investigat ions shall be perf ormed on the basis of an appropr iate plan of inve stigation reflecting the \nlatest scientific and technical knowledge and defined in such a way as to conf irm or refute the manufacturer's \nclaims regarding the safety , performa nce and aspects relating to benefit-r isk of devices as refer red to in \nArticle 62(1); the clinical inve stigations shall include an adequate number of obser vations to guarant ee the \nscientific validity of the conclusions. The rationale for the design and chosen statistical methodology shall be \npresent ed as further descr ibed in Section 3.6 of Chapt er II of this Annex. \n2.2. The procedures used to perform the clinical inve stigation shall be appropr iate to the device under investigation. \n2.3. The research methodologies used to perform the clinical investig ation shall be appropr iate to the device under \ninve stigation. \n2.4. Clinical investig ations shall be performed in accordance with the clinical inve stigation plan by a sufficient \nnumber of intended users and in a clinical environment that is representative of the intended normal conditions \nof use of the device in the target patient population. Clinical investigat ions shall be in line with the clinical \nevaluation plan as referred to in Part A of Annex XIV. \n2.5. All the appropr iate technical and functional features of the device, in particular those involving safety and \nperforma nce, and their expect ed clinical outcomes shall be appropr iately addressed in the investig ational design. \nA list of the technical and functional features of the device and the relat ed expect ed clinical outcomes shall be \nprovided. \n2.6. The endpoints of the clinical investigation shall address the intended purpose, clinical benefi ts, performa nce and \nsafety of the device. The endpoints shall be determined and assessed using scientifical ly valid methodologies. \nThe primar y endpoint shall be appropr iate to the device and clinically relevant. \n2.7. Investi gators shall have access to the technical and clinical data regarding the device. Personnel involved in the \nconduct of an investiga tion shall be adequate ly instr ucted and trained in the proper use of the investigational \ndevice, and as regar ds the clinical investig ation plan and good clinical practice. This training shall be verified \nand where necessar y arranged by the sponsor and documente d appropr iately . \n2.8. The clinical investigation repor t, signed by the inve stigat or, shall contain a critical evaluation of all the data \ncollect ed during the clinical inve stigation, and shall include any negat ive findings . \nCHA PTER II \nDOCUMENT ATION REGARDING THE APPLIC ATION FOR CLINIC AL INVESTIGA TION \nFor inve stigational devices covered by Article 62, the sponsor shall draw up and submit the application in accordance \nwith Article 70 accompanied by the following documents: \n1. Application form \nThe application form shall be duly filled in, containing information regarding: \n1.1. name, address and contact details of the sponsor and, if applicable, name, address and contact details of its \ncontact person or lega l representative in accordance with Article 62(2) established in the Union; 5.5.2017 L 117/167 Official Jour nal of the European Union EN \n 1.2. if diffe rent from those in Section 1.1, name, address and contact details of the manuf acturer of the device \nintended for clinical investigation and, if applicable, of its author ised representative; \n1.3. title of the clinical inve stigation; \n1.4. status of the clinical investig ation application (i.e. first submission, resubmission, signif icant amendment); \n1.5. details and/or reference to the clinical evaluation plan; \n1.6. If the application is a resubmission with regar d to a device for whic h an application has been already submitte d, \nthe date or dates and referen ce number or numbers of the earlier application or in the case of signif icant \namendment, reference to the original application. The sponsor shall identify all of the change s from the \nprevious application together with a rationale for those changes , in particular , whether any chang es have been \nmade to address conclusions of previous compet ent author ity or ethics committe e reviews; \n1.7. if the application is submitted in parallel with an application for a clinical trial in accordance with \nRegulation (EU) No 536/2014, reference to the official registration number of the clinical trial; \n1.8. identif ication of the Member States and third countr ies in whic h the clinical investigation is to be conducted as \npart of a multicentre or multinational study at the time of application; \n1.9. a brief descr iption of the inve stigational device, its classif ication and other information necessar y for the identif i\ncation of the device and device type; \n1.10. information as to whether the device incor porate s a medicinal substance, including a human blood or plasma \nderivative or whether it is manufact ured utilising non-viable tissues or cells of human or animal origin, or their \nderivatives; \n1.11. summar y of the clinical investiga tion plan including the objective or objectives of the clinical inve stigation, the \nnumber and gender of subjects, criteria for subject selection, whether there are subjects under 18 years of age, \ndesign of the investigat ion such as controlled and/or randomised studies, planned dates of commencement and \nof compl etion of the clinical inve stigation; \n1.12. if applicable, information regarding a compar ator device, its classification and other information necessar y for \nthe identif ication of the compar ator device; \n1.13. evidence from the sponsor that the clinical investigat or and the investigational site are capable of conducting \nthe clinical investigation in accordance with the clinical investigation plan; \n1.14. details of the anticipated start date and duration of the inve stigation; \n1.15. details to identify the notified body , if already involved at the stage of application for a clinical investig ation; \n1.16. conf irmation that the sponsor is awar e that the compe tent author ity may contact the ethics committee that is \nassessing or has assessed the application; and \n1.17. the statement refer red to in Section 4.1. \n2. Investi gator's Broch ure \nThe investig ator's brochur e (IB) shall contain the clinical and non-clinical information on the inve stigational \ndevice that is relevant for the investigation and available at the time of application. Any updates to the IB or \nother relevant information that is newly available shall be brought to the attention of the investigat ors in \na timely manner . The IB shall be clearly identif ied and contain in particular the following information: \n2.1. Identif ication and descr iption of the device, including information on the intended purpose, the risk classifi \ncation and applicable classificat ion rule pursuant to Annex VIII, design and manuf actur ing of the device and \nreferen ce to previous and similar generations of the device. 5.5.2017 L 117/168 Official Jour nal of the European Union EN \n 2.2. Manufactur er's instr uctions for installation, maintenance, maintaining hygiene standards and for use, including \nstorag e and handling requirements, as well as, to the extent that such information is available, information to be \nplaced on the label, and instr uctions for use to be provided with the device when placed on the mark et. In \naddition, information relating to any relevant training required. \n2.3. Pre-clinical evaluation based on relevant pre-clinical testing and exper imental data, in particular regarding in- \ndesign calculations, in vitro tests, ex vivo tests , animal tests, mech anical or electr ical tests, reliability tests, sterili\nsation validation, software verification and validation, performa nce tests , evaluation of biocompa tibility and \nbiological safet y, as applicable. \n2.4. Existing clinical data, in particular: \n— from relevant scientific literature available relating to the safety , perf ormance, clinical benefi ts to patients, \ndesign character istics and intended purpose of the device and/or of equivalent or similar devices; \n— other relevant clinical data available relating to the safety , performa nce, clinical benefits to patients, design \ncharact eristics and intende d purpose of equivalent or similar devices of the same manuf acturer , including \nlength of time on the market and a review of performa nce, clinical benefi t and safety- related issues and any \ncorrective actions taken. \n2.5. Summar y of the benefit-r isk analysis and the risk manag ement, including information regarding kno wn or \nforeseeable risks, any undesirable effects, contraindications and warnings. \n2.6. In the case of devices that incor porate a medicinal substance, including a human blood or plasma derivative or \ndevices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, \ndetailed information on the medicinal substance or on the tissues, cells or their derivatives, and on the \ncompl iance with the relevant general safety and performance requirements and the specific risk manag ement in \nrelation to the substance or tissues, cells or their derivatives, as well as evidence for the added value of \nincor poration of such constituents in relation to the clinical benefit and/or safety of the device. \n2.7. A list detailing the fulfilment of the relevant general safety and performa nce requirements set out in Annex I, \nincluding the standards and CS applied, in full or in part, as well as a descr iption of the solutions for fulfilling \nthe relevant general safet y and performa nce requirements, in so far as those standards and CS have not or have \nonly been partly fulfilled or are lacking. \n2.8. A detailed descr iption of the clinical procedures and diagnostic tests used in the course of the clinical inve sti\ngation and in particular information on any deviation from normal clinical practice. \n3. Clinical Investigation Plan \nThe clinical investig ation plan (CIP) shall set out the rationale, objectives, design methodology , monitor ing, \nconduct, record-kee ping and the method of analysis for the clinical investigation. It shall contain in particular \nthe information as laid down in this Annex. If part of this information is submitted in a separate document, it \nshall be referen ced in the CIP. \n3.1. General \n3.1.1. Sing le identif ication number of the clinical investigat ion, as refer red to in Article 70(1). \n3.1.2. Identif ication of the sponsor — name, address and contact details of the sponsor and, where applicable, the \nname, address and contact details of the sponsor's contact person or legal representative in accordance with \nArticle 62(2) established in the Union. \n3.1.3. Information on the principal investigat or at each investigat ional site, the coordinating inve stigat or for the \ninve stigation, the address details for each investig ational site and the emergency contact details for the principal \ninve stigat or at each site. The roles, responsibilities and qualif ications of the various kinds of investigat ors shall \nbe specif ied in the CIP. 5.5.2017 L 117/169 Official Jour nal of the European Union EN \n 3.1.4. A brief descr iption of how the clinical inve stigation is financed and a brief descr iption of the agreement \nbetween the sponsor and the site. \n3.1.5. Overall synopsis of the clinical investiga tion, in an official Union language determined by the Member State \nconcer ned. \n3.2. Identif ication and descr iption of the device, including its intende d purpose, its manufacturer , its traceability , the \ntarget population, mater ials coming into contact with the human body , the medical or surgical procedures \ninvolved in its use and the necessar y training and exper ience for its use, back ground literature review , the \ncurrent state of the art in clinical care in the relevant field of application and the proposed benefi ts of the new \ndevice. \n3.3. Risks and clinical benefits of the device to be examined, with justification of the corresponding expect ed clinical \noutcomes in the clinical investigation plan. \n3.4. Descr iption of the relevance of the clinical investig ation in the cont ext of the state of the art of clinical practice. \n3.5. Objectives and hypotheses of the clinical inve stigation. \n3.6. Design of the clinical investigat ion with evidence of its scientifi c robustness and validity . \n3.6.1. General information such as type of investigat ion with rationale for choosing it, for its endpoints and for its \nvariables as set out in the clinical evaluation plan. \n3.6.2. Information on the investigational device, on any compar ator and on any other device or medication to be used \nin the clinical investig ation. \n3.6.3. Information on subjects, selection criteria, size of investigat ion population, representativeness of investig ation \npopulation in relation to targe t population and, if applicable, information on vulnerable subjects involved such \nas children, pregnant women, immuno-comprom ised or, elderly subjects. \n3.6.4. Details of measures to be take n to minimise bias, such as randomisation, and management of potential \nconf ounding factors. \n3.6.5. Descr iption of the clinical procedures and diagnostic methods relating to the clinical investig ation and in \nparticular highlighting any deviation from normal clinical practice. \n3.6.6. Monitoring plan. \n3.7. Statistical considerations, with justification, including a power calculation for the sample size, if applicable. \n3.8. Data manage ment. \n3.9. Information about any amendments to the CIP. \n3.10. Policy regar ding follow-up and management of any deviations from the CIP at the investigational site and clear \nprohibition of use of waivers from the CIP. \n3.11. Accountability regar ding the device, in particular control of access to the device, follow-up in relation to the \ndevice used in the clinical investig ation and the retur n of unused, expired or malfunctioning devices. \n3.12. State ment of compl iance with the recognised ethical principles for medical research involving humans, and the \nprinciples of good clinical practice in the field of clinical inve stigations of devices, as well as with the applicable \nregulatory requirements. \n3.13. Descr iption of the Informed consent process. \n3.14. Safety repor ting, including definit ions of adverse events and serious adverse events, device deficiencies, \nprocedures and timelines for repor ting. 5.5.2017 L 117/170 Official Jour nal of the European Union EN \n 3.15. Criteria and procedures for follow-up of subjects following the end, temporar y halt or early term ination of an \ninve stigation, for follow-up of subjects who have withdrawn their consent and procedures for subjects lost to \nfollow-up. Such procedures shall for implantable devices, cover as a minimum traceability . \n3.16. A descr iption of the arrang ements for taking care of the subjects after their participation in the clinical investi \ngation has ended, where such additional care is necessar y because of the subjects' participation in the clinical \ninve stigation and where it differ s from that normally expect ed for the medical condition in question. \n3.17. Policy as regards the establishment of the clinical investigation repor t and publication of results in accordance \nwith the legal requirements and the ethical principles refer red to in Section 1 of Chapt er I. \n3.18. List of the technical and functional features of the device, with specifi c mention of those covered by the inve sti\ngation. \n3.19. Bibliography . \n4. Other information \n4.1. A signed state ment by the natural or legal person responsible for the manufa cture of the investig ational device \nthat the device in question conf orms to the general safety and performa nce requirements apar t from the aspects \ncovered by the clinical investigat ion and that, with regar d to those aspects, ever y precaution has been taken to \nprotect the health and safety of the subject. \n4.2. Where applicable according to national law, copy of the opinion or opinions of the ethics committee or \ncommittees concer ned. Where according to national law the opinion or opinions of the ethics committee or \ncommittees is not required at the time of the submission of the application, a copy of the opinion or opinions \nshall be submitted as soon as available. \n4.3. Proof of insurance cover or indemnifi cation of subjects in case of injur y, pursuant to Article 69 and the \ncorresponding national law. \n4.4. Documents to be used to obtain informed consent, including the patient information sheet and the informed \nconsent document. \n4.5. Descr iption of the arrange ments to compl y with the applicable rules on the prote ction and conf identiality of \npersonal data, in particular: \n— organisational and technical arrange ments that will be imp lemented to avoid unauthor ised access, disclosure, \ndissemination, alteration or loss of information and personal data processed; \n— a descr iption of measures that will be imple mented to ensure confidentiality of records and personal data of \nsubjects; and \n— a descr iption of measures that will be imple mented in case of a data secur ity breac h in order to mitig ate the \npossible adverse effects. \n4.6. Full details of the available technical documentation, for example detailed risk analysis/manag ement documen \ntation or specifi c test repor ts, shall, upon request, be submitte d to the compet ent author ity reviewing an \napplication. \nCHAPTER III \nOTHER OBLIGA TIONS OF THE SPONSOR \n1. The sponsor shall under take to keep available for the compet ent national author ities any documentation \nnecessar y to provide evidence for the documentation refer red to in Chapt er II of this Annex. If the sponsor is \nnot the natural or legal person responsible for the manuf acture of the investig ational device, that oblig ation may \nbe fulfilled by that person on behalf of the sponsor . 5.5.2017 L 117/171 Official Jour nal of the European Union EN \n 2. The Sponsor shall have an agreement in place to ensure that any serious adverse events or any other event as \nrefer red to in Article 80(2) are repor ted by the investig ator or investigat ors to the sponsor in a timely manner . \n3. The documentation mentioned in this Annex shall be kept for a period of at least 10 years after the clinical \ninve stigation with the device in question has ended, or, in the event that the device is subsequently placed on \nthe market, at least 10 years after the last device has been placed on the mark et. In the case of implantable \ndevices, the period shall be at least 15 years. \nEach Member State shall require that this documentation is kept at the disposal of the compet ent author ities for \nthe period referred to in the first subparagraph in case the sponsor , or its contact person or legal representative \nas referred to in Article 62(2) established within its territory, goes bankr upt or ceases its activity prior to the \nend of this period. \n4. The Sponsor shall appoint a monitor that is independent from the investigat ional site to ensure that the investi \ngation is conducted in accordance with the CIP, the principles of good clinical practice and this Regulation. \n5. The Sponsor shall compl ete the follow-up of inve stigation subjects. \n6. The Sponsor shall provide evidence that the investigation is being conduct ed in line with good clinical practice, \nfor instance through internal or external inspection. \n7. The Sponsor shall prepare a clinical investig ation repor t whic h includes at least the following: \n— Cover/introduct ory page or pages indicating the title of the investigation, the investig ational device, the \nsing le identif ication number , the CIP number and the details with signatures of the coordinating investigat ors \nand the principal investigat ors from each investig ational site. \n— Details of the author and date of the repor t. \n—A summar y of the investigat ion covering the title, purpose of the investig ation, descr iption of the investi\ngation, inve stigational design and methods used, the results of the inve stigation and conclusion of the \ninvestigation. The compl etion date of the investigation, and in particular details of early termination, \ntemporar y halts or suspensions of investig ations. \n— Investigational device descr iption, in particular clearly defined intended purpose. \n— A summar y of the clinical investigat ion plan covering objectives, design, ethical aspects, monitori ng and \nquality measures, selection criteria, target patient populations, sample size, treatment schedules, follow-up \nduration, concomitant treatments, statistical plan, including hypothesis, sample size calculation and analysis \nmethods, as well as a justification. \n— Results of the clinical investig ation covering, with rationale and justif ication, subject demographics, analysis \nof results related to chosen endpoints, details of subgroup analysis, as well as compl iance with the CIP, and \ncovering follow-up of missing data and of patients withdrawing from the clinical investigation, or lost to \nfollow-up. \n— Summar y of serious adverse events, adverse device effects, device deficiencies and any relevant corrective \nactions. \n— Discussion and overall conclusions covering safety and performa nce results, assessment of risks and clinical \nbenefits, discussion of clinical relevance in accordance with clinical state of the art, any specific precautions \nfor specifi c patient populations, implications for the investigational device, limitations of the investigation. 5.5.2017 L 117/172 Official Jour nal of the European Union EN",
"title": "ANNEX XV"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
| null |
{
"text": "LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDIC AL PURPOSE REFERRED TO IN \nART ICLE 1(2) \n1. Contact lenses or other items intended to be introduced into or onto the eye. \n2. Products intende d to be tota lly or partially introduced into the human body through surgically invasive means for \nthe purpose of modifying the anat omy or fixation of body parts with the excep tion of tattooing products and \npiercings. \n3. Substances, combinations of substances, or items intende d to be used for facial or other dermal or mucous \nmembrane filling by subcutaneous, submucous or intrader mal injection or other introduction, excl uding those for \ntattooing. \n4. Equipment intended to be used to reduce, remo ve or destro y adipose tissue, such as equipment for liposuction, \nlipolysis or lipoplasty . \n5. High intensi ty electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for \nuse on the human body , including coherent and non-coherent sources, monoc hromatic and broad spectr um, such as \nlasers and intense pulsed light equipment, for skin resur facing, tattoo or hair remo val or other skin treatment. \n6. Equipment intended for brain stimulation that apply electr ical currents or magnetic or electromagnetic fields that \npenetrat e the cranium to modify neuronal activity in the brain. 5.5.2017 L 117/173 Official Jour nal of the European Union EN",
"title": "ANNEX XVI"
}
|
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 andRegulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
|
(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regulator y framew ork
for medical devices, other than in vitro diagnostic medical devices. However , a fundamental revision of those
Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framew ork for
medical devices which ensures a high level of safety and health whilst suppor ting inno vation.
(2) This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking
as a base a high level of prot ection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector . At the same time, this Regulation sets high standards of
quality and safety for medical devices in order to meet common safety concer ns as regar ds such products. Both
objectives are being pursued simultaneously and are inseparably linked whilst one not being secondar y to the
other . As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessor ies on the Union mark et thus allowing them to benefit from the principle of free movement of goods. 5.5.2017 L 117/1 Official Jour nal of the European Union EN
(1)Opinion of 14 Febr uary 2013 (OJ C 133, 9.5.2013, p. 52).
(2)Position of the European Parliament of 2 Apr il 2014 (not yet published in the Official Jour nal) and position of the Council at first reading
of 7 March 2017 (not yet published in the Official Jour nal).
(3)Council Directive 90/385/EEC of 20 June 1990 on the appro ximation of the laws of the Member States relating to active implantable
medical devices (OJ L 189, 20.7.1990, p. 17).
(4)Council Directive 93/42/EEC of 14 June 1993 concer ning medical devices (OJ L 169, 12.7.1993, p. 1).
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical devices by
ensur ing, among other things, that data generat ed in clinical investigations are reliable and robust and that the
safety of the subjects participating in a clinical investigat ion is protect ed.
(3) This Regulation does not seek to harmonise rules relating to the further making available on the mark et of
medical devices after they have already been put into service such as in the conte xt of second-hand sales.
(4) Key elements of the existing regulat ory approach, such as the super vision of notified bodies, conf ormity
assessment procedures, clinical investig ations and clinical evaluation, vigilance and mark et surveillance should be
significantly reinf orced, whilst provisions ensur ing transparency and traceability regar ding medical devices should
be introduced, to impro ve health and safety .
(5) To the extent possible, guidance developed for medical devices at internati onal level, in particular in the context
of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices
Regulat ors Forum (IMDRF), should be take n into account to promote the global convergence of regulations
whic h contr ibutes to a high level of safety protection worldwide, and to facilitate trade, in particular in the
provisions on Unique Device Identif ication, general safety and performa nce requirements, technical documen
tation, classification rules, conf ormity assessment procedures and clinical investig ations.
(6) For histo rical reasons, active implantable medical devices, covered by Directive 90/385/EEC, and other medical
devices, covered by Directive 93/42/EEC, were regulate d in two separate legal instr uments. In the interest of
simplification, both directives, whic h have been amended several times, should be replaced by a sing le legislative
act applicable to all medical devices other than in vitro diagnostic medical devices.
(7) The scope of application of this Regulation should be clearly delimit ed from other Union harmonisation
legislation concer ning products, such as in vitro diagnostic medical devices, medicinal products, cosmetics and
food. Theref ore, Regulation (EC) No 178/2002 of the European Parliament and of the Council (1) should be
amended to exclude medical devices from its scope.
(8) It should be the responsibility of the Member State s to decide on a case-by- case basis whether or not a product
falls within the scope of this Regulation. In order to ensure consistent qualification decisions in that regar d across
all Member States, particularly with regard to borderline cases, the Commission should be allowed to, on its own
initiative or at the duly substantiated request of a Member State , having consulted the Medical Device
Coordination Group (‘MDCG’), decide on a case-by-case basis whether or not a specific product, catego ry or
group of products falls within the scope of this Regulation. When deliberating on the regulatory status of
products in borderline cases involving medicinal products, human tissues and cells, biocidal products or food
products, the Commission should ensure an appropr iate level of consultation of the European Medicines
Agen cy (EMA), the European Chemicals Agen cy and the European Food Safety Author ity, as relevant.
(9) Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility of
taking a Union-wide decision regarding the regulatory status of a product should also be introduced in
Regulation (EC) No 1223/2009 of the European Parliament and of the Council (2).
(10) Products which combine a medicinal product or substance and a medical device are regulate d either under this
Regulation or under Directive 2001/83/EC of the European Parliament and of the Council. (3) The two legislative
acts should ensure appropr iate inter action in term s of consultations during pre-market assessment, and of
exchange of information in the cont ext of vigilance activities involving such combination products. For medicinal
products that integrat e a medical device part, compl iance with the general safety and perf ormance requirements
laid down in this Regulation for the device part should be adequately assessed in the context of the mark eting
author isation for such medicinal products. Directive 2001/83/EC should theref ore be amended. 5.5.2017 L 117/2 Official Jour nal of the European Union EN
(1)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Autho rity and laying down procedures in matters of food safety
(OJ L 31, 1.2.2002, p. 1).
(2)Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342,
22.12.2009, p. 59).
(3)Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to
medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(11) Union legislation, in particular Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1)
and Directive 2004/23/EC of the European Parliament and of the Council (2), is incomplet e in respect of certain
products manufact ured utilising derivatives of tissues or cells of human origin that are non-viable or are rendered
non-viable. Such products should come under the scope of this Regulation, provided they compl y with the
definition of a medical device or are covered by this Regulation.
(12) Certain groups of products for whic h a manufacturer claims only an aesthetic or another non-medical purpose
but which are similar to medical devices in term s of functioning and risks prof ile should be covered by this
Regulation. In order for manuf acturers to be able to demonstrate the conf ormity of such products, the
Commission should adop t common specifications at least with rega rd to application of risk manag ement and,
where necessar y, clinical evaluation regarding safety . Such common specifications should be developed
specifical ly for a group of products without an intende d medical purpose and should not be used for conf ormity
assessment of the analogous devices with a medical purpose. Devices with both a medical and a non-medical
intende d purpose should fulfil both the requirements applicable to devices with, and to devices without, an
intende d medical purpose.
(13) As is the case for products that contain viable tissues or cells of human or animal origin, that are explicitly
excl uded from Directives 90/385/EEC and 93/42/EEC and hence from this Regulation, it should be clarified that
products that contain or consist of viable biological mate rials or viable organisms of another origin in order to
achi eve or suppor t the intende d purpose of those products are not covered by this Regulation either .
(14) The requirements laid down in Directive 2002/98/EC of the European Parliament and of the Council (3) should
continue to apply .
(15) There is scientific uncer tainty about the risks and benefits of nanomat erials used for devices. In order to ensure
a high level of health protection, free movement of goods and legal certainty for manuf acturers, it is necessar y to
introduce a unif orm definition for nanomat erials based on Commission Recommendation 2011/696/EU (4), with
the necessar y flexibility to adapt that definit ion to scientific and technical progress and subsequent regulatory
development at Union and international level. In the design and manuf acture of devices, manufacturers should
take special care when using nanopar ticles for which there is a high or medium poten tial for internal exposure.
Such devices should be subject to the most stringent conf ormity assessment procedures. In preparation of
implementing acts regulating the practical and unif orm application of the corresponding requirements laid down
in this Regulation, the relevant scientifi c opinions of the relevant scientific committees should be taken into
account.
(16) Safety aspects addressed by Directive 2014/30/EU of the European Parliament and of the Council (5) are an
integra l part of the general safety and performa nce requirements laid down in this Regulation for devices.
Consequently , this Regulation should be considered a lex specialis in relation to that Directive.
(17) This Regulation should include requirements regar ding the design and manufacture of devices emitting ionizing
radiation without affecting the application of Council Directive 2013/59/Euratom (6) which pursues other
objectives.
(18) This Regulation should include requirements for devices' design, safety and performa nce character istics whic h are
developed in such a way as to prevent occupational injur ies, including protection from radiation. 5.5.2017 L 117/3 Official Jour nal of the European Union EN
(1)Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therap y medicinal
products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121).
(2)Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safet y for the
donation, procurement, testing, processing, preser vation, storag e and distr ibution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
(3)Directive 2002/98/EC of the European Parliament and of the Council of 27 Januar y 2003 setting standards of quality and safet y for the
collection, testing, processing, storag e and distr ibution of human blood and blood components (OJ L 33, 8.2.2003, p. 30).
(4)Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomater ial (OJ L 275, 20.10.2011, p. 38).
(5)Directive 2014/30/EU of the European Parliament and of the Council of 26 Febr uary 2014 on the harmonisation of the laws of the
Member States relating to electromagnetic compatibility (OJ L 96, 29.3.2014. p. 79).
(6)Council Directive 2013/59/Eurato m of 5 December 2013 laying down basic safet y standards for protection against the dangers arising
from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and
2003/122/Eurato m (OJ L 13, 17.1.2014, p. 1).
(19) It is necessar y to clarify that software in its own right, when specifically intende d by the manufa cturer to be used
for one or more of the medical purposes set out in the definition of a medical device, qualifi es as a medical
device, while software for general purposes, even when used in a healthcare setting, or software intended for
life-st yle and well-being purposes is not a medical device. The qualifi cation of software, either as a device or an
accessor y, is independent of the software's location or the type of inter connection between the software and
a device.
(20) The definitions in this Regulation, regarding devices themselves, the making available of devices, economic
operat ors, users and specific processes, the conf ormity assessment, clinical investig ations and clinical evaluations,
post-market surveillance, vigilance and market surveillance, standards and other technical specifications, should
be aligned with well-established practice in the field at Union and international level in order to enhance legal
certainty .
(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information
society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the
Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service
to persons within the Union compl y with the requirements of this Regulation, where the product in question is
placed on the market or the service is provided in the Union.
(22) To recognise the important role of standardisation in the field of medical devices, compl iance with harmonised
standards as defined in Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2) should
be a means for manufacturers to demonstrate conf ormity with the general safety and perf ormance requirements
and other legal requirements, such as those relating to quality and risk manage ment, laid down in this
Regulation.
(23) Directive 98/79/EC of the European Parliament and of the Council (3) allows the Commission to adop t common
technical specifications for specifi c cate gories of in vitro diagnostic medical devices. In areas where no harmonised
standards exist or where they are insuffi cient, the Commission should be empo wered to lay down common
specifications whic h provide a means of compl ying with the general safety and performa nce requirements, and
the requirements for clinical investig ations and clinical evaluation and/or post-market clinical follow-up, laid
down in this Regulation.
(24) Common specifications (‘CS’) should be developed after consulting the relevant stakeho lders and taking account
of European and internati onal standards.
(25) The rules applicable to devices should be aligned, where appropr iate, with the New Legislative Framew ork for the
Mark eting of Products, which consists of Regulation (EC) No 765/2008 of the European Parliament and of the
Council (4) and Decision No 768/2008/EC of the European Parliament and of the Council (5).
(26) The rules on Union market surveillance and control of products entering the Union market laid down in
Regulation (EC) No 765/2008 apply to devices covered by this Regulation which does not prevent Member States
from choosing the compet ent author ities to carry out those tasks.
(27) It is appropr iate to set out clearly the general oblig ations of the differ ent economic operat ors, including importers
and distr ibutors, building on the New Legislative Framework for the Marketing of Products, without prejudice to
the specifi c oblig ations laid down in the various parts of this Regulation, to enhance understanding of the
requirements laid down in this Regulation and thus to impro ve regulatory compl iance by the relevant operat ors. 5.5.2017 L 117/4 Official Jour nal of the European Union EN
(1)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the
provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(2)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation,
amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC,
2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(3)Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331,
7.12.1998, p. 1).
(4)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accredita
tion and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008,
p. 30).
(5)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of
products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(28) For the purpose of this Regulation, the activities of distr ibut ors should be deemed to include acquisition, holding
and supplying of devices.
(29) Several of the oblig ations on manuf acturers, such as clinical evaluation or vigilance repor ting, that were set out
only in the Annex es to Directives 90/385/EEC and 93/42/EEC, should be incor porate d into the enacting
provisions of this Regulation to facilitat e its application.
(30) Health institutions should have the possibility of manufactur ing, modifying and using devices in-house and
thereby address, on a non-industr ial scale, the specifi c needs of target patient groups which cannot be met at the
appropr iate level of performance by an equivalent device available on the market. In that context, it is
appropr iate to provide that certain rules of this Regulation, as regards medical devices manufact ured and used
only within health institutions, including hospitals as well as institutions, such as laborat ories and public health
institutes that suppor t the healthcare system and/or address patient needs, but whic h do not treat or care for
patients directly , should not apply , since the aims of this Regulation would still be met in a propor tionate
manner . It should be noted that the concept of ‘health institution’ does not cover establishments primar ily
claiming to pursue health inter ests or health y lifestyles, such as gyms, spas, wellness and fitness centres. As
a result, the exem ption applicable to health institutions does not apply to such establishments.
(31) In view of the fact that natural or legal persons can claim compe nsation for damage caused by a defective device
in accordance with applicable Union and national law, it is appropr iate to require manuf acturers to have
measures in place to provide suffic ient financia l coverage in respect of their poten tial liability under Council
Directive 85/374/EEC (1). Such measures should be propor tionate to the risk class, type of device and the size of
the enter prise. In this conte xt, it is also appropr iate to lay down rules concer ning the facilitation, by a compet ent
author ity, of the provision of information to persons who may have been injured by a defe ctive device.
(32) To ensure that devices manufactured in series production continue to be in conf ormity with the requirements of
this Regulation and that exper ience from the use of the devices they manufacture is taken into account for the
production process, all manufacturers should have a quality manage ment syste m and a post-market surveillance
system in place which should be propor tionate to the risk class and the type of the device in question. In
addition, in order to minimize risks or prevent incidents relat ed to devices, manufacturers should establish
a system for risk manag ement and a system for repor ting of incidents and field safet y corrective actions.
(33) The risk manage ment system should be carefully aligned with and reflected in the clinical evaluation for the
device, including the clinical risks to be addressed as part of clinical investigat ions, clinical evaluation and
post-market clinical follow up. The risk managemen t and clinical evaluation processes should be inter-dependent
and should be regularly update d.
(34) It should be ensured that super vision and control of the manuf acture of devices, and the post-market surveillance
and vigilance activities concer ning them, are carried out within the manufacturer's organisation by a person
responsible for regulatory compl iance who fulfils minimum conditions of qualification.
(35) For manufacturers who are not established in the Union, the author ised representative plays a pivotal role in
ensur ing the compliance of the devices produced by those manufacturers and in serving as their contact person
established in the Union. Given that pivot al role, for the purposes of enforcement it is appropr iate to make the
author ised representative legally liable for defe ctive devices in the event that a manuf acturer established outside
the Union has not compl ied with its general oblig ations. The liability of the author ised representative provided
for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and according ly the
author ised representative should be jointly and severally liable with the impor ter and the manuf acturer . The tasks
of an author ised representative should be defined in a written mandate. Consider ing the role of author ised
representatives, the minimum requirements they should meet should be clearly defined, including the
requirement of having available a person who fulfils minimum conditions of qualifi cation whic h should be
similar to those for a manufact urer's person responsible for regulatory compl iance. 5.5.2017 L 117/5 Official Jour nal of the European Union EN
(1)Council Directive 85/374/EEC of 25 July 1985 on the appro ximation of the laws, regulations and administrative provisions of the
Member States concer ning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(36) To ensure legal certainty in respect of the oblig ations incumbent on economic operators, it is necessar y to clarify
when a distr ibutor , importer or other person is to be considered the manufacturer of a device.
(37) Parallel trade in products already placed on the mark et is a lawful form of trade within the intern al mark et on the
basis of Article 34 TFEU subject to the limitations arising from the need for prot ection of health and safety and
from the need for prote ction of intellectual proper ty rights provided for under Article 36 TFEU. Application of
the principle of parallel trade is, however , subject to different interpr etations in the Member States. The
conditions, in particular the requirements for relabelling and repack aging, should theref ore be specif ied in this
Regulation, taking into account the case-law of the Cour t of Justice (1) in other relevant sector s and existing good
practice in the field of medical devices.
(38) The reprocessing and further use of sing le-use devices should only take place where permitted by national law
and while compl ying with the requirements laid down in this Regulation. The reprocessor of a sing le-use device
should be considered to be the manuf acturer of the reprocessed device and should assume the oblig ations
incumbent on manuf acturers under this Regulation. Never theless, Member States should have the possibility of
deciding that the obligations relating to reprocessing and re-use of sing le-use devices within a health institution
or by an exte rnal reprocessor acting on its behalf may differ from the oblig ations on a manufacturer descr ibed in
this Regulation. In principle, such divergence should only be permitted where reprocessing and reuse of
sing le-use devices within a health institution or by an exte rnal reprocessor are compliant with CS that have been
adopt ed, or, in the absence of such CS, with relevant harmonised standards and national provisions. The
reprocessing of such devices should ensure an equivalent level of safety and perf ormance to that of the
corresponding initial sing le-use device.
(39) Patients who are implante d with a device should be given clear and easily accessible essential information
allowing the implant ed device to be identified and other relevant information about the device, including any
necessar y health risk warnings or precautions to be take n, for examp le indications as to whether or not it is
compati ble with certain diagnostic devices or with scanners used for secur ity controls.
(40) Devices should, as a general rule, bear the CE marking to indicate their conf ormity with this Regulation so that
they can move freely within the Union and be put into service in accordance with their intended purpose.
Member States should not creat e obstacles to the placing on the market or putting into service of devices that
compl y with the requirements laid down in this Regulation. However , Member States should be allowed to decide
whether to restr ict the use of any specific type of device in relation to aspects that are not covered by this
Regulation.
(41) The traceability of devices by means of a Unique Device Identification syste m (UDI syste m) based on international
guidance should signif icantly enhance the effectiveness of the post-market safety-relat ed activities for devices,
whic h is owing to impro ved incident repor ting, target ed field safety corrective actions and bette r monitoring by
compet ent author ities. It should also help to reduce medical errors and to fight against falsified devices. Use of
the UDI system should also imp rove purchas ing and wast e disposal policies and stoc k-management by health
institutions and other economic operators and, where possible, be compati ble with other authentication systems
already in place in those settings.
(42) The UDI system should apply to all devices placed on the mark et excep t custom -made devices, and be based on
internationally recognised principles including definitions that are compat ible with those used by major trade
partners. In order for the UDI system to become functional in time for the application of this Regulation,
detailed rules should be laid down in this Regulation.
(43) Transparency and adequate access to information, appropr iately presented for the intended user , are essential in
the public interest, to protect public health, to empower patients and healthcare professionals and to enable them
to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in
the regulatory system.
(44) One key aspect in fulfilling the objectives of this Regulation is the creation of a European database on medical
devices (Eudamed) that should integrat e differ ent electronic systems to collate and process information regarding
devices on the mark et and the relevant economic operat ors, certain aspects of conf ormity assessment, notified 5.5.2017 L 117/6 Official Jour nal of the European Union EN
(1)Judgment of 28 July 2011 in Orifarm and Parano va, joined cases C‑400/09 and C‑207/10, ECLI:EU:C:2011:519.
bodies, certificates, clinical inve stigations, vigilance and mark et surveillance. The objectives of the database are to
enhance overall transparency , including through better access to information for the public and healthcare profes
sionals, to avoid multiple repor ting requirements, to enhance coordination between Member States and to
streamline and facilitat e the flow of information between economic operat ors, notifi ed bodies or sponsors and
Member States as well as between Member States among themselves and with the Commission. Within the
internal market, this can be ensured effectively only at Union level and the Commission should theref ore
further develop and manag e the European databank on medical devices set up by Commission
Decision 2010/227/EU (1).
(45) To facilitate the functioning of Eudamed, an intern ationally recognised medical device nomenclature should be
available free of charge to manufacturers and other natural or legal persons required by this Regulation to use
that nomenclature. Further more, that nomenclature should be available, where reasonably practicable, free of
charge also to other stake holders.
(46) Eudamed's electronic systems regar ding devices on the market, the relevant economic operat ors and certificates
should enable the public to be adequat ely informed about devices on the Union mark et. The electronic syste m on
clinical investig ations should serve as a tool for the cooperation between Member States and for enabling
sponsors to submit, on a voluntar y basis, a sing le application for several Member States and to repor t serious
adverse events, device deficiencies and related update s. The electronic system on vigilance should enable manufa c
turers to repor t serious incidents and other repor table events and to suppor t the coordination of the evaluation
of such incidents and events by compet ent author ities. The electronic syste m regar ding mark et surveillance
should be a tool for the exchange of information between compet ent author ities.
(47) In respect of data collated and processed through the electronic systems of Eudamed, Directive 95/46/EC of the
European Parliament and of the Council (2) applies to the processing of personal data carried out in the
Member States, under the super vision of the Member States' compet ent author ities, in particular the public
independent author ities designated by the Member States. Regulation (EC) No 45/2001 of the European
Parliament and of the Council (3) applies to the processing of personal data carried out by the Commission
within the framewor k of this Regulation, under the super vision of the European Data Protection Super visor . In
accordance with Regulation (EC) No 45/2001, the Commission should be designate d as the controller of
Eudamed and its electronic systems .
(48) For implantable devices and for class III devices, manufacturers should summar ise the main safety and
performa nce aspects of the device and the outcome of the clinical evaluation in a document that should be
publicly available.
(49) The summar y of safety and clinical perf ormance for a device should include in particular the place of the device
in the context of diagnostic or therapeutic options taking into account the clinical evaluation of that device when
compar ed to the diagnostic or therapeutic altern atives and the specifi c conditions under which that device and its
alternatives can be considered.
(50) The proper functioning of notified bodies is crucial for ensur ing a high level of health and safety prote ction and
citizens' conf idence in the system . Designation and monitoring of notified bodies by the Member States, in
accordance with detailed and strict criteria, should theref ore be subject to controls at Union level.
(51) Notifie d bodies' assessments of manufa cturers' technical documentation, in particular documentation on clinical
evaluation, should be critically evaluated by the author ity responsible for notifi ed bodies. That evaluation should
be part of the risk-based approac h to the oversight and monitori ng activities of notifi ed bodies and should be
based on sampli ng of the relevant documentation.
(52) The position of notified bodies vis-à-vis manuf acturers should be strengthened, including with regar d to their
right and duty to carry out unannounced on-site audits and to conduct physical or laboratory tests on devices to
ensure continuous compl iance by manufacturer s after receip t of the original certification. 5.5.2017 L 117/7 Official Jour nal of the European Union EN
(1)Commission Decision 2010/227/EU of 19 Apr il 2010 on the European Databank for Medical Devices (OJ L 102, 23.4.2010, p. 45).
(2)Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to
the processing of personal data and on the free movement of such data (OJ L 281, 23.11.1995, p. 31).
(3)Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on the protection of individuals with
regar d to the processing of personal data by the Community institutions and bodies and on the free movement of such data (OJ L 8,
12.1.2001, p. 1).
(53) To increase transparency with regar d to the oversight of notified bodies by national author ities, the author ities
responsible for notified bodies should publish information on the national measures governing the assessment,
designation and monitori ng of notifi ed bodies. In accordance with good administrative practice, this information
should be kept up to date by those author ities in particular to reflect relevant, significant or substantive chang es
to the procedures in question.
(54) The Member State in whic h a notified body is established should be responsible for enforcing the requirements of
this Regulation with regard to that notifi ed body .
(55) In view , in particular , of the responsibility of Member States for the organisation and deliver y of health services
and medical care, they should be allowed to lay down additional requirements on notifi ed bodies designat ed for
the conf ormity assessment of devices and established on their territory as far as issues that are not regulat ed in
this Regulation are concer ned. Any such additional requirements laid down should not affect more specifi c
horizontal Union legislation on notified bodies and equal treatment of notifi ed bodies.
(56) For class III implantable devices and class IIb active devices intended to administ er and/or remo ve a medicinal
product, notifi ed bodies should, excep t in certain cases, be oblig ed to request exper t panels to scrutinise their
clinical evaluation assessment repor t. Compet ent author ities should be informed about devices that have been
grant ed a certificate following a conf ormity assessment procedure involving an exper t panel. The consultation of
exper t panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-r isk medical
devices by shar ing exper tise on clinical aspects and developing CS on categor ies of devices that have undergone
that consultation process.
(57) For class III devices and for certain class IIb devices, a manuf acturer should be able to consult voluntar ily an
exper t panel, prior to that manufact urer's clinical evaluation and/or investigation, on its clinical development
strateg y and on proposals for clinical investigat ions.
(58) It is necessar y, in particular for the purpose of the conf ormity assessment procedures, to maintain the division of
devices into four product classes in line with international practice. The classification rules, which are based on
the vulnerability of the human body , should take into account the poten tial risks associated with the technical
design and manufacture of the devices. To maintain the same level of safety as provided by Directive 90/385/EEC,
active implantable devices should be in the highest risk class.
(59) Rules under the old regime applied to invasive devices do not suffi ciently take account of the level of
invasiveness and poten tial toxicity of certain devices whic h are introduced into the human body . In order to
obtain a suitable risk-based classification of devices that are compo sed of substances or of combinations of
substances that are absorbed by or locally dispersed in the human body , it is necessar y to introduce specific classi
fication rules for such devices. The classif ication rules should take into account the place where the device
performs its action in or on the human body , where it is introduced or applied, and whether a syste mic
absor ption of the substances of whic h the device is compo sed, or of the products of metabolism in the human
body of those substances occurs.
(60) The conf ormity assessment procedure for class I devices should be carried out, as a general rule, under the sole
responsibility of manuf acturers in view of the low level of vulnerability associated with such devices. For class IIa,
class IIb and class III devices, an appropr iate level of involvement of a notified body should be compul sory.
(61) The conf ormity assessment procedures for devices should be further strengthened and streamlined whilst the
requirements for notified bodies as rega rds the performance of their assessments should be clearly specifi ed to
ensure a level playing field.
(62) It is appropr iate that certificates of free sale contain information that make s it possible to use Eudamed in order
to obtain information on the device, in particular with regard to whether it is on the mark et, withdra wn from the
mark et or recalled, and on any certificate on its conf ormity .
(63) To ensure a high level of safety and performance, demonstration of compl iance with the general safet y and
performa nce requirements laid down in this Regulation should be based on clinical data that, for class III devices
and implantable devices should, as a general rule, be sourced from clinical investig ations that have been carried
out under the responsibility of a sponsor . It should be possible both for the manufacturer and for another natural
or legal person to be the sponsor taking responsibility for the clinical investig ation. 5.5.2017 L 117/8 Official Jour nal of the European Union EN
(64) The rules on clinical investig ations should be in line with well-established international guidance in this field,
such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical
devices for human subjects, so as to make it easier for the results of clinical inve stigations conduct ed in the
Union to be accept ed as documentation outside the Union and to make it easier for the results of clinical investi
gations conduct ed outside the Union in accordance with intern ational guidelines to be accept ed within the Union.
In addition, the rules should be in line with the most recent version of the World Medical Association
Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects.
(65) It should be left to the Member State where a clinical inve stigation is to be conduct ed to determine the
appropr iate author ity to be involved in the assessment of the application to conduct a clinical investig ation and
to organise the involvement of ethics committees within the timelines for the author isation of that clinical inve sti
gation as set out in this Regulation. Such decisions are a matte r of internal organisation for each Member State.
In that conte xt, Member States should ensure the involvement of laypersons, in particular patients or patients'
organisations. They should also ensure that the necessar y exper tise is available.
(66) Where, in the course of a clinical investig ation, harm caused to a subject leads to the civil or criminal liability of
the investigat or or the sponsor being invoked, the conditions for liability in such cases, including issues of
causality and the level of damages and sanctions, should remain governed by national law.
(67) An electronic syste m should be set up at Union level to ensure that ever y clinical investigat ion is recorded and
repor ted in a publicly accessible database. To prote ct the right to the protection of personal data, recognised by
Article 8 of the Char ter of Fundamental Rights of the European Union (‘the Char ter’), no personal data of
subjects participating in a clinical inve stigation should be recorded in the electronic system . To ensure synergies
with the area of clinical trials on medicinal products, the electronic system on clinical investig ations should be in
teroperable with the EU database to be set up for clinical trials on medicinal products for human use.
(68) Where a clinical investigat ion is to be conduct ed in more than one Member State, the sponsor should have the
possibility of submitting a sing le application in order to reduce administrative burden. In order to allow for
resource-shar ing and to ensure consistency regarding the assessment of the health and safety-relat ed aspects of
the inve stigational device and of the scientific design of that clinical inve stigation, the procedure for the
assessment of such sing le application should be coordinat ed between the Member States under the direction of
a coordinating Member State. Such coordinated assessment should not include the assessment of intrinsically
national, local and ethical aspects of a clinical inve stigation, including informed consent. For an initial period of
seven years from the date of application of this Regulation, Member States should be able to participate on
a voluntar y basis in the coordinat ed assessment. After that period, all Member States should be oblig ed to
participat e in the coordinated assessment. The Commission, based on the exper ience gained from the voluntar y
coordination between Member State s, should draw up a repor t on the application of the relevant provisions
regar ding the coordinat ed assessment procedure. In the event that the findings of the repor t are negative, the
Commission should submit a proposal to extend the period of participation on a voluntary basis in the
coordinat ed assessment procedure.
(69) Sponsors should repor t certain adverse events and device deficiencies that occur during clinical investigations to
the Member States in which those clinical investigat ions are being conducted. Member States should have the
possibility of terminating or suspending the inve stigations or revoki ng the author isation for those investig ations,
if considered necessar y to ensure a high level of prot ection of the subjects participating in a clinical investig ation.
Such information should be communicated to the other Member States.
(70) The sponsor of a clinical investigation should submit a summar y of results of the clinical investigation that is
easily understandable for the intended user together with the clinical investig ation repor t, where applicable,
within the timelines laid down in this Regulation. Where it is not possible to submit the summar y of the results
within the defined timelines for scientific reasons, the sponsor should justify this and specify when the results
will be submitte d.
(71) This Regulation should cover clinical investig ations intende d to gather clinical evidence for the purpose of
demonstrating conf ormity of devices and should also lay down basic requirements regarding ethical and scientifi c
assessments for other types of clinical investigat ions of medical devices. 5.5.2017 L 117/9 Official Jour nal of the European Union EN
(72) Incapacitated subjects, minors, pregnant women and breastf eeding women require specifi c protection measures.
However , it should be left to Member States to deter mine the legally designat ed representatives of incapacitated
subjects and minors.
(73) The principles of replacement, reduction and refinement in the area of animal exper imentation laid down in the
Directive 2010/63/EU of the European Parliament and of the Council (1) should be obser ved. In particular , the
unnecessar y duplication of tests and studies should be avoided.
(74) Manufact urers should play an active role during the post-market phase by systematically and actively gatheri ng
information from post-market exper ience with their devices in order to updat e their technical documentation and
cooperat e with the national compet ent author ities in charg e of vigilance and mark et surveillance activities. To this
end, manuf acturers should establish a compre hensive post-market surveillance system, set up under their quality
manag ement system and based on a post-market surveillance plan. Relevant data and information gathere d
through post-market surveillance, as well as lessons learned from any implemented preventive and/or corrective
actions, should be used to updat e any relevant part of technical documentation, such as those relating to risk
assessment and clinical evaluation, and should also serve the purpose of transparency .
(75) In order to better protect health and safety regarding devices on the market, the electronic system on vigilance
for devices should be made more effective by creating a central portal at Union level for repor ting serious
incidents and field safety corrective actions.
(76) Member States should take appropr iate measures to raise awareness among healthcare professionals, users and
patients about the impor tance of repor ting incidents. Healthcare profess ionals, users and patients should be
encourag ed and enabled to repor t suspect ed serious incidents at national level using harmonised formats. The
national compet ent author ities should inform manuf acturers of any suspected serious incidents and, where
a manufacturer conf irms that such an incident has occur red, the author ities concer ned should ensure that
appropr iate follow-up action is taken in order to minimise recur rence of such incidents.
(77) The evaluation of repor ted serious incidents and field safet y corrective actions should be conduct ed at national
level but coordination should be ensured where similar incidents have occur red or field safety corrective actions
have to be carried out in more than one Member State, with the objective of shar ing resources and ensur ing
consiste ncy regarding the corrective action.
(78) In the cont ext of the investigation of incidents, the compet ent author ities should take into account, where
appropr iate, the information provided by and views of relevant stak eholders, including patient and healthcare
profess ionals' organisations and manuf acturers' associations.
(79) The repor ting of serious adverse events or device deficiencies during clinical investig ations and the repor ting of
serious incidents occur ring after a device has been placed on the mark et should be clearly distinguished to avoid
double repor ting.
(80) Rules on mark et surveillance should be included in this Regulation to reinf orce the rights and oblig ations of the
national compet ent author ities, to ensure effective coordination of their mark et surveillance activities and to
clarify the applicable procedures.
(81) Any statistically significant increase in the number or sever ity of incidents that are not serious or in expecte d
side-eff ects that could have a signif icant impact on the benefit-r isk analysis and whic h could lead to unaccep table
risks should be repor ted to the compet ent author ities in order to permit their assessment and the adoptio n of
appropr iate measures.
(82) An exper t committee, the Medical Device Coordination Group (MDCG), composed of persons designat ed by the
Member States based on their role and exper tise in the field of medical devices including in vitro diagnostic
medical devices, should be established to fulfil the task s confe rred on it by this Regulation and by
Regulation (EU) 2017/746 of the European Parliament and of the Council (2), to provide advice to the
Commission and to assist the Commission and the Member States in ensur ing a harmonised implementation of
this Regulation. The MDCG should be able to establish subgroups in order to have access to necessar y in-dep th 5.5.2017 L 117/10 Official Jour nal of the European Union EN
(1)Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for
scientific purposes (OJ L 276, 20.10.2010, p. 33).
(2)Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 Apr il 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (see page 176 of this Offi cial Jour nal).
technical exper tise in the field of medical devices including in vitro diagnostic medical devices. When establishing
subgroups, appropr iate consideration should be given to the possibility of involving existing groups at Union
level in the field of medical devices.
(83) Exper t panels and exper t laboratori es should be designat ed by the Commission on the basis of their up-to -date
clinical, scientifi c or technical exper tise, with the aim of providing scientific, technical and clinical assistance to
the Commission, the MDCG, manufacturers and notified bodies in relation to the implementation of this
Regulation. Moreo ver, exper t panels should fulfil the task s of providing an opinion on clinical evaluation
assessment repor ts of notifi ed bodies in the case of certain high-r isk devices.
(84) Closer coordination between national compet ent author ities through information exchang e and coordinat ed
assessments under the direction of a coordinating author ity is essential for ensur ing a consistently high level of
health and safety protection within the internal mark et, in particular in the areas of clinical investigat ions and
vigilance. The principle of coordinated exchange and assessment should also apply across other author ity
activities descr ibed in this Regulation, such as the designation of notifi ed bodies and should be encourag ed in the
area of market surveillance of devices. Joint working, coordination and communication of activities should also
lead to more efficient use of resources and exper tise at national level.
(85) The Commission should provide scientifi c, technical and corresponding logistical suppor t to coordinating
national author ities and ensure that the regulator y system for devices is effectively and unif ormly implemented at
Union level based on sound scientifi c evidence.
(86) The Union and, where appropr iate, the Member States should actively participate in intern ational regulatory
cooperation in the field of medical devices to facilitate the exchange of safety- relat ed information regarding
medical devices and to foste r the further development of international regulatory guidelines that promote the
adopt ion in other jurisdictions of regulations that lead to a level of health and safety protection equivalent to that
set by this Regulation.
(87) Member States should take all necessar y measures to ensure that the provisions of this Regulation are
implemented, including by laying down effective, propor tionate and dissuasive penalties for their infringement.
(88) Whilst this Regulation should not affect the right of Member States to levy fees for activities at national level,
Member States should, in order to ensure transparency , inform the Commission and the other Member States
before they decide on the level and structure of such fees. In order to further ensure transparency , the structure
and level of the fees should be publicly available on request.
(89) This Regulation respects the fundamental rights and obser ves the principles recognised in particular by the
Char ter and in particular human dignity , the integrit y of the person, the protection of personal data, the freedom
of art and science, the freedom to conduct business and the right to proper ty. This Regulation should be applied
by the Member States in accordance with those rights and principles.
(90) The power to adopt delegat ed acts in accordance with Article 290 TFEU should be delegat ed to the Commission
in order to amend certain non-essential provisions of this Regulation. It is of particular imp ortance that the
Commission carry out appropr iate consultations during its preparatory work, including at exper t level, and that
those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement
of 13 Apr il 2016 on Better Law-Making (1). In particular , to ensure equal participation in the preparation of
delegat ed acts, the European Parliament and the Council receive all documents at the same time as Member States'
exper ts, and their exper ts syste matically have access to meetings of Commission exper t groups dealing with
preparation of delegat ed acts.
(91) In order to ensure unif orm conditions for the implementation of this Regulation, implementing powers
should be conferred on the Commission. Those powers should be exer cised in accordance with
Regulation (EU) No 182/2011 of the European Parliament and of the Council (2). 5.5.2017 L 117/11 Official Jour nal of the European Union EN
(1)OJ L 123, 12.5.2016, p. 1.
(2)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 Febr uary 2011 laying down the rules and general
principles concer ning mec hanisms for control by Member States of the Commission's exercise of implem enting powers (OJ L 55,
28.2.2011, p. 13).
(92) The advisor y procedure should be used for implementing acts that set out the form and presentation of the data
elements of manufact urers' summar ies of safety and clinical performa nce, and that establish the model for
certificates of free sale, given that such implementing acts are of a procedural nature and do not directly have an
impact on health and safety at Union level.
(93) The Commission should adop t immediate ly applicable implementing acts where, in duly justif ied cases relating to
the extensi on to the territory of the Union of a national derogat ion from the applicable conf ormity assessment
procedures, imperative grounds of urgency so require.
(94) In order to enable it to designat e issuing entities, exper t panels and exper t laborat ories, implementing powers
should be conferr ed on the Commission.
(95) To allow economic operat ors, especially SMEs, notified bodies, Member State s and the Commission to adap t to
the chang es introduced by this Regulation and to ensure its proper application, it is appropr iate to provide for
a sufficient transitional period for that adap tation and for the organisational arrangements that are to be made.
However , certain parts of the Regulation that directly affect Member States and the Commission should be
implemented as soon as possible. It is also particularly important that, by the date of application of this
Regulation, a suffi cient number of notified bodies be designat ed in accordance with the new requirements so as
to avoid any shor tage of medical devices on the market. Nonetheless, it is necessar y that any designation of
a notified body in accordance with the requirements of this Regulation prior to the date of its application be
without prejudice to the validity of the designation of those notified bodies under Directives 90/385/EEC and
93/42/EEC and to their capacity to continue issuing valid certificates under those two Directives until the date of
application of this Regulation.
(96) In order to ensure a smooth transition to the new rules for registration of devices and of certificates, the
oblig ation to submit the relevant information to the electronic systems set up at Union level pursuant to this
Regulation should, in the event that the corresponding IT system s are developed according to plan, only become
fully effective from 18 months after the date of application of this Regulation. Dur ing this transitional period,
certain provisions of Directives 90/385/EEC and 93/42/EEC should remain in force. However , in order to avoid
multiple registrations, economic operators and notified bodies who register in the relevant electronic syste ms set
up at Union level pursuant to this Regulation should be considered to be in compl iance with the registration
requirements adopt ed by the Member States pursuant to those provisions.
(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the oblig ation to
place the UDI carrier on the label of the device should vary from one to five years after the date of application of
this Regulation depending upon the class of the device concer ned.
(98) Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set of rules applies to the
placing of medical devices on the mark et and the relat ed aspects covered by this Regulation. Manufacturers'
oblig ations as regards the making available of documentation regarding devices they placed on the market and
manuf acturers' and Member State s' oblig ations as regards vigilance activities for devices placed on the mark et
pursuant to those Directives should however continue to apply . While it should be left to Member States to
decide how to organise vigilance activities, it is desirable for them to have the possibility of repor ting incidents
relat ed to devices placed on the mark et pursuant to the Directives using the same tools as those for repor ting on
devices placed on the mark et pursuant to this Regulation. It is further more appropr iate, in order to ensure
a smooth transition from the old regime to the new regime, to provide that Commission
Regulation (EU) No 207/2012 (1) and Commission Regulation (EU) No 722/2012 (2) should remain in force and
continue to apply unless and until repealed by implementing acts adopt ed by the Commission pursuant to this
Regulation. 5.5.2017 L 117/12 Official Jour nal of the European Union EN
(1)Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instr uctions for use of medical devices (OJ L 72, 10.3.2012,
p. 28).
(2)Commission Regulation (EU) No 722/2012 of 8 August 2012 concer ning particular requirements as regards the requirements laid down
in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured
utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).
Decision 2010/227/EU adopt ed in implementation of those Directives and Directive 98/79/EC should also
remain in force and continue to apply until the date when Eudamed becomes fully functional. Conversely , no
such maintenance in force is required for Commission Directives 2003/12/EC (1) and 2005/50/EC (2) and
Commission Implementing Regulation (EU) No 920/2013 (3).
(99) The requirements of this Regulation should be applicable to all devices placed on the mark et or put into service
from the date of application of this Regulation. However , in order to provide for a smooth transition it should be
possible, for a limited period of time from that date, for devices to be placed on the mark et or put into service by
virtue of a valid certificate issued pursuant to Directive 90/385/EEC or pursuant to Directive 93/42/EEC.
(100) The European Data Protection Super visor has given an opinion (4) pursuant to Article 28(2) of Reg
ulation (EC) No 45/2001.
(101) Since the objectives of this Regulation, namely to ensure the smooth functioning of the intern al market as
regar ds medical devices and to ensure high standards of quality and safet y for medical devices, thus ensur ing
a high level of protect ion of health and safety of patients, users and other persons, cannot be suffi ciently achi eved
by the Member State s but can rather , by reason of its scale and effects, be bette r achieve d at Union level, the
Union may adopt measures, in accordance with the principle of subsidiar ity as set out in Article 5 of the Treaty
on European Union. In accordance with the principle of propor tionality , as set out in that Article, this Regulation
does not go beyond what is necessar y in order to achi eve those objectives,
| null |
{
"text": "CORREL ATION TABLE \nCouncil Directive 90/385/EEC Council Directive 93/42/EEC This Regulation \nArticle 1(1) Article 1(1) Article 1(1) \nArticle 1(2) Article 1(2) Article 2 \nArticle 1(3) Article 1(3) first subparagraph Article 1(9) first subparagraph \n— Article 1(3) second subparagraph Article 1(9) second subparagraph \nArticle 1(4) and (4a) Article 1(4) and (4a) Article 1(8) first subparagraph \nArticle 1(5) Article 1(7) Article 1(11) \nArticle 1(6) Article 1(5) Article 1(6) \n— Article 1(6) — \n— Article 1(8) Article 1(13) \nArticle 2 Article 2 Article 5(1) \nArticle 3 first paragraph Article 3 first paragraph Article 5(2) \nArticle 3 second paragraph Article 3 second paragraph Article 1(12) \nArticle 4(1) Article 4(1) Article 24 \nArticle 4(2) Article 4(2) Article 21(1) and (2) \nArticle 4(3) Article 4(3) Article 21(3) \nArticle 4(4) Article 4(4) Article 10(11) \nArticle 4(5)(a) Article 4(5) first subparagraph Article 20(6) \nArticle 4(5)(b) Article 4(5) second subparagraph — \nArticle 5(1) Article 5(1) Article 8(1) \nArticle 5(2) Article 5(2) Article 8(2) \nArticle 6(1) Articles 5(3) and 6 — \nArticle 6(2) Article 7(1) Article 114 \nArticle 7 Article 8 Articles 94 to 97 \n— Article 9 Article 51 \nArticle 8(1) Article 10(1) Articles 87(1) and 89 (2) \nArticle 8(2) Article 10(2) Article 87(10) and Article 87(11) \nfirst subparagraph \nArticle 8(3) Article 10(3) Article 89(7) \nArticle 8(4) Article 10(4) Article 91 \nArticle 9(1) Article 11(1) Article 52(3) \n— Article 11(2) Article 52(6) \n— Article 11(3) Article 52(4) and (5) \n— Article 11(4) — \n— Article 11(5) Article 52(7) 5.5.2017 L 117/174 Official Jour nal of the European Union EN \n Council Directive 90/385/EEC Council Directive 93/42/EEC This Regulation \nArticle 9(2) Article 11 (6) Article 52(8) \nArticle 9(3) Article 11(8) Article 11(3) \nArticle 9(4) Article 11(12) Article 52(12) \nArticle 9(5) Article 11(7) — \nArticle 9(6) Article 11(9) Article 53(1) \nArticle 9(7) Article 11(10) Article 53(4) \nArticle 9(8) Article 11(11) Article 56(2) \nArticle 9(9) Article 11(13) Article 59 \nArticle 9(10) Article 11(14) Article 4(5) and Article 122 \nthird paragraph \n— Article 12 Article 22 \n— Article 12a Article 17 \nArticle 9a(1) first indent Article 13(1)(c) — \nArticle 9a(1) second indent Article 13(1)(d) Article 4(1) \n— Article 13(1)(a) Article 51(3)(a) and Article 51(6) \n— Article 13(1)(b) Article 51(3)(b) and Article 51(6) \nArticle 10 Article 15 Articles 62 to 82 \nArticle 10a(1), second senten ce of \nArticle 10a(2) and Article 10a(3) Article 14(1), second senten ce of \nArticle 14(2) and Article 14(3) Articles 29(4), 30 and 31 \nArticle 10a(2), first sentence Article 14(2) first senten ce Article 11(1) \nArticle 10b Article 14a Articles 33 and 34 \nArticle 10c Article 14b Article 98 \nArticle 11(1) Article 16(1) Articles 42 and 43 \nArticle 11(2) Article 16(2) Article 36 \nArticle 11(3) Article 16(3) Article 46(4) \nArticle 11(4) Article 16(4) — \nArticle 11(5) Article 16(5) Article 56(5) \nArticle 11(6) Article 16(6) Article 56(4) \nArticle 11(7) Article 16(7) Articles 38(2) and 44(2) \nArticle 12 Article 17 Article 20 \nArticle 13 Article 18 Articles 94 to 97 \nArticle 14 Article 19 Article 99 \nArticle 15 Article 20 Article 109 \nArticle 15a Article 20a Article 102 \nArticle 16 Article 22 — \nArticle 17 Article 23 — \n— Article 21 — 5.5.2017 L 117/175 Official Jour nal of the European Union EN",
"title": "ANNEX XVII"
}
|
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