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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 d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":{"heading":"General obligations of manufacturers","text":(...TRUNCATED)
| {"text":"TECHNIC AL DOCUMENT ATION \nThe technical documentation and, if applicable, the summar y th(...TRUNCATED)
|
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"TEC HNIC AL DOCUMENT ATION ON POST -MARKET SUR VEILL ANCE \nThe technical documentation on (...TRUNCATED)
|
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"out in Sections 14 and 15 conf orm to the type descr ibed in the EU type-examination certif(...TRUNCATED)
|
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"CE MARKING OF CONFORMIT Y \n1. The CE marking shall consist of the initials ‘CE’ takin(...TRUNCATED)
|
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"INFOR MA TION TO BE SUBMITTED UPON THE REGISTRA TION OF DEVICES AND ECO NOMIC \nOPERA TORS (...TRUNCATED)
|
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":null,"Article 100":{"heading":"Electronic system on marke(...TRUNCATED)
| {"text":"REQUIREMENTS TO BE MET BY NOTIFIED BODIES \n1. ORGANISA TIONAL AND GENERAL REQUIREMENTS \n(...TRUNCATED)
|
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":{"heading":"Compete(...TRUNCATED)
| {"text":"CLASSIFIC ATION RULES \nCHAPTER I \nDEFINITIONS SPECIFIC TO CLASSIFIC ATION RULES \n1. DUR(...TRUNCATED)
|
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"CONFORMIT Y ASSESSMENT BASED ON A QUALIT Y MANA GEMENT SYSTEM AND ON ASSESSMENT OF \nTECHNI(...TRUNCATED)
|
"REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical d(...TRUNCATED)
| "(1) Council Directive 90/385/EEC (3) and Council Directive 93/42/EEC (4) constitute the Union regu(...TRUNCATED)
| {"articles":{"Article 1":null,"Article 10":null,"Article 100":null,"Article 101":null,"Article 102":(...TRUNCATED)
| {"text":"CONFORMIT Y ASSESSMENT BASED ON TYPE-EXAMINA TION \n1. EU type-examination is the procedur(...TRUNCATED)
|
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