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Provide a summary and key takeaways from the given text. | This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability
for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official
Journal of the European Union and available in EUR-Lex. Those o... | Summary: This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability
for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official
Journal of the European Union and available... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 2
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 and Regulation (EC) No 1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/EEC
(Text wit... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 2
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 and Regulation (EC) No 1223/2009 and repealing Council
Directives 90/385/EEC and 9... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 3
5. Where justified on account of the similarity between a devic e with
an intended medical purpose placed on the market and a product
without an intended medical purpose in respect of their charact eristics
and risks, the Commission is empowered to adopt delegated acts in... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 3
5. Where justified on account of the similarity between a devic e with
an intended medical purpose placed on the market and a product
without an intended medical purpose in respect of their charact eristics
and risks, the Commission is empowered to ado... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 4
8. Any device which, when placed on the market or put into serv ice,
incorporates, as an integral part, a substance which, if used s eparately,
would be considered to be a medicinal product as defined in poi nt 2 of
Article 1 of Directive 2001/83/EC, including a medicinal... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 4
8. Any device which, when placed on the market or put into serv ice,
incorporates, as an integral part, a substance which, if used s eparately,
would be considered to be a medicinal product as defined in poi nt 2 of
Article 1 of Directive 2001/83/EC, i... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 5
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 h ea... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 5
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 mee... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 6
and which does not achieve its principal intended action by pha r
macological, 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:
— dev... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 6
and which does not achieve its principal intended action by pha r
macological, 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 medic... |
Define the key term or concept related to medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 7
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 t o
be an implantable device;
(6) ‘invasive device’ means any device which, in whole... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 7
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 t o
be an implantable device;
(6) ‘invasive device’ means any de... |
Define the key term or concept related to medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 8
(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 exte rnal
dimensions is in... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 8
(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 exte rn... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 9
(27) ‘making available on the market’ means any supply of a dev ice,
other than an investigational device, for distribution, consump tion
or use on the Union market in the course of a commercial activi ty,
whether in return for payment or free of charge;
(28) ‘placing o... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 9
(27) ‘making available on the market’ means any supply of a dev ice,
other than an investigational device, for distribution, consump tion
or use on the Union market in the course of a commercial activi ty,
whether in return for payment or free of charg... |
Define the key term or concept related to medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 10
(40) ‘conformity assessment’ means the process demonstrating wh ether
the requirements of this Regulation relating to a device have b een
fulfilled;
(41) ‘conformity assessment body’ means a body that performs
third-party conformity assessment activities including cali... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 10
(40) ‘conformity assessment’ means the process demonstrating wh ether
the requirements of this Regulation relating to a device have b een
fulfilled;
(41) ‘conformity assessment body’ means a body that performs
third-party conformity assessment activ... |
Define the key term or concept related to medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 11
(51) ‘clinical evidence’ means clinical data and clinical evalu ation
results pertaining to a device of a sufficient amount and quali ty
to allow a qualified assessment of whether the device is safe a nd
achieves the intended clinical benefit(s), when used as intende d b... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 11
(51) ‘clinical evidence’ means clinical data and clinical evalu ation
results pertaining to a device of a sufficient amount and quali ty
to allow a qualified assessment of whether the device is safe a nd
achieves the intended clinical benefit(s), when... |
Define the key term or concept related to medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 12
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or m ental
impairment or birth defect;
(59) ‘device deficiency’ means any inadequacy in the identity, quality,
durability, reliability, safety or performance of an investigat ional
device... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 12
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or m ental
impairment or birth defect;
(59) ‘device deficiency’ means any inadequacy in the identity, quality,
durability, reliability, safety or performance of an inve... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 13
(68) ‘field safety corrective action’ means corrective action t aken by a
manufacturer for technical or medical reasons to prevent or red uce
the risk of a serious incident in relation to a device made ava ilable
on the market;
(69) ‘field safety notice’ means a commun... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 13
(68) ‘field safety corrective action’ means corrective action t aken by a
manufacturer for technical or medical reasons to prevent or red uce
the risk of a serious incident in relation to a device made ava ilable
on the market;
(69) ‘field safety no... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 14
4. When deliberating on the possible regulatory status as a dev ice of
products involving medicinal products, human tissues and cells, biocides
or food products, the Commission shall ensure an appropriate le vel of
consultation of the European Medicines Agency (EMA), th... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 14
4. When deliberating on the possible regulatory status as a dev ice of
products involving medicinal products, human tissues and cells, biocides
or food products, the Commission shall ensure an appropriate le vel of
consultation of the European Medici... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 15
(ii) the details necessary to identify the devices;
(iii) a declaration that the devices meet the general safety an d
performance requirements set out in Annex I to this Regulation
and, where applicable, information on which requirements are
not fully met with a reason... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 15
(ii) the details necessary to identify the devices;
(iii) a declaration that the devices meet the general safety an d
performance requirements set out in Annex I to this Regulation
and, where applicable, information on which requirements are
not ful... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 16
3. Upon request by a competent authority, any natural or legal person
offering a device in accordance with paragraph 1 or providing a service
in accordance with paragraph 2 shall make available a copy of t he
EU declaration of conformity of the device concerned.
4. A ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 16
3. Upon request by a competent authority, any natural or legal person
offering a device in accordance with paragraph 1 or providing a service
in accordance with paragraph 2 shall make available a copy of t he
EU declaration of conformity of the devic... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 17
2. References in this Regulation to harmonised standards shall also
include the monographs of the European Pharmacopoeia adopted in
accordance with the Convention on the Elaboration of a European Phar
macopoeia, in particular on surgical sutures and on interaction bet... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 17
2. References in this Regulation to harmonised standards shall also
include the monographs of the European Pharmacopoeia adopted in
accordance with the Convention on the Elaboration of a European Phar
macopoeia, in particular on surgical sutures and... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 18
The Commission is empowered to adopt delegated acts in accordan ce
with Article 115 amending, in the light of technical progress, the
Annexes II and III.
5. Manufacturers of custom-made devices shall draw up, keep up to
date and keep available for competent authorities... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 18
The Commission is empowered to adopt delegated acts in accordan ce
with Article 115 amending, in the light of technical progress, the
Annexes II and III.
5. Manufacturers of custom-made devices shall draw up, keep up to
date and keep available for c... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 19
(a) a strategy for regulatory compliance, including compliance with
conformity assessment procedures and procedures for management
of modifications to the devices covered by the system;
(b) identification of applicable general safety and performance
requirements and e... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 19
(a) a strategy for regulatory compliance, including compliance with
conformity assessment procedures and procedures for management
of modifications to the devices covered by the system;
(b) identification of applicable general safety and performance ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 20
Where the device presents a serious risk, manufacturers shall i mmedi
ately inform the competent authorities of the Member States in which
they made the device available and, where applicable, the notif ied body
that issued a certificate for the device in accordance with... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 20
Where the device presents a serious risk, manufacturers shall i mmedi
ately inform the competent authorities of the Member States in which
they made the device available and, where applicable, the notif ied body
that issued a certificate for the devic... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 21
Manufacturers shall, in a manner that is proportionate to the r isk class,
type of device and the size of the enterprise, have measures in place to
provide sufficient financial coverage in respect of their poten tial liability
under Directive 85/374/EEC, without prejudi... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 21
Manufacturers shall, in a manner that is proportionate to the r isk class,
type of device and the size of the enterprise, have measures in place to
provide sufficient financial coverage in respect of their poten tial liability
under Directive 85/374/... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 22
2. The designation shall constitute the authorised representati ve's
mandate, it shall be valid only when accepted in writing by the auth
orised representative and shall be effective at least for all d evices of the
same generic device group.
3. The authorised represe... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 22
2. The designation shall constitute the authorised representati ve's
mandate, it shall be valid only when accepted in writing by the auth
orised representative and shall be effective at least for all d evices of the
same generic device group.
3. Th... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 23
(g) immediately inform the manufacturer about complaints and re ports
from healthcare professionals, patients and users about suspect ed
incidents related to a device for which they have been designat ed;
(h) terminate the mandate if the manufacturer acts contrary to its... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 23
(g) immediately inform the manufacturer about complaints and re ports
from healthcare professionals, patients and users about suspect ed
incidents related to a device for which they have been designat ed;
(h) terminate the mandate if the manufacturer ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 24
Article 13
General obligations of importers
1. Importers shall place on the Union market only devices that are in
conformity with this Regulation.
2. In order to place a device on the market, importers shall ve rify
that:
(a) the device has been CE marked and that ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 24
Article 13
General obligations of importers
1. Importers shall place on the Union market only devices that are in
conformity with this Regulation.
2. In order to place a device on the market, importers shall ve rify
that:
(a) the device has been... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 25
7. Importers who consider or have reason to believe that a devi ce
which they have placed on the market is not in conformity with this
Regulation shall immediately inform the manufacturer and its au thorised
representative. Importers shall co-operate with the manufacture... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 25
7. Importers who consider or have reason to believe that a devi ce
which they have placed on the market is not in conformity with this
Regulation shall immediately inform the manufacturer and its au thorised
representative. Importers shall co-operate ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 26
Where a distributor considers or has reason to believe that a d evice is
not in conformity with the requirements of this Regulation, it shall not
make the device available on the market until it has been broug ht into
conformity, and shall inform the manufacturer and, wh... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 26
Where a distributor considers or has reason to believe that a d evice is
not in conformity with the requirements of this Regulation, it shall not
make the device available on the market until it has been broug ht into
conformity, and shall inform the ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 27
(a) a diploma, certificate or other evidence of formal qualific ation,
awarded on completion of a university degree or of a course of
study recognised as equivalent by the Member State concerned, i n
law, medicine, pharmacy, engineering or another relevant scient ific
d... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 27
(a) a diploma, certificate or other evidence of formal qualific ation,
awarded on completion of a university degree or of a course of
study recognised as equivalent by the Member State concerned, i n
law, medicine, pharmacy, engineering or another rel... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 28
(a) a diploma, certificate or other evidence of formal qualific ation,
awarded on completion of a university degree or of a course of
study recognised as equivalent by the Member State concerned, i n
law, medicine, pharmacy, engineering or another relevant scient ific
d... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 28
(a) a diploma, certificate or other evidence of formal qualific ation,
awarded on completion of a university degree or of a course of
study recognised as equivalent by the Member State concerned, i n
law, medicine, pharmacy, engineering or another rel... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 29
3. A distributor or importer that carries out any of the activi ties
mentioned in points (a) and (b) of paragraph 2 shall indicate o n the
device or, where that is impracticable, on its packaging or in a
document accompanying the device, the activity carried out toge the... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 29
3. A distributor or importer that carries out any of the activi ties
mentioned in points (a) and (b) of paragraph 2 shall indicate o n the
device or, where that is impracticable, on its packaging or in a
document accompanying the device, the activity ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 30
3. By way of derogation from paragraph 2, as regards single-use
devices that are reprocessed and used within a health instituti on,
Member States may decide not to apply all of the rules relating to
manufacturers' obligations laid down in this Regulation provide d that... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 30
3. By way of derogation from paragraph 2, as regards single-use
devices that are reprocessed and used within a health instituti on,
Member States may decide not to apply all of the rules relating to
manufacturers' obligations laid down in this Regul... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 31
6. Only single-use devices that have been placed on the market in
accordance with this Regulation, or prior to ►M1 26 May 2021 ◄ in
accordance with Directive 93/42/EEC, may be reprocessed.
7. Only reprocessing of single-use devices that is considered s afe
according t... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 31
6. Only single-use devices that have been placed on the market in
accordance with this Regulation, or prior to ►M1 26 May 2021 ◄ in
accordance with Directive 93/42/EEC, may be reprocessed.
7. Only reprocessing of single-use devices that is considere... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 32
(d) any other information to ensure safe use of the device by t he
patient, including the information in point (u) of Section 23.4 of
Annex I.
The information referred to in the first subparagraph shall be provided,
for the purpose of making it available to the partic... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 32
(d) any other information to ensure safe use of the device by t he
patient, including the information in point (u) of Section 23.4 of
Annex I.
The information referred to in the first subparagraph shall be provided,
for the purpose of making it ava... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 33
4. The Commission is empowered to adopt delegated acts in
accordance with Article 115 amending the minimum content of the
EU declaration of conformity set out in Annex IV in the light o f
technical progress.
Article 20
CE marking of conformity
1. Devices, other th... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 33
4. The Commission is empowered to adopt delegated acts in
accordance with Article 115 amending the minimum content of the
EU declaration of conformity set out in Annex IV in the light o f
technical progress.
Article 20
CE marking of conformity
... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 34
Member States may require that the manufacturer of a custom-mad e
device submit to the competent authority a list of such devices which
have been made available in their territory.
3. At trade fairs, exhibitions, demonstrations or similar event s,
Member States shall ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 34
Member States may require that the manufacturer of a custom-mad e
device submit to the competent authority a list of such devices which
have been made available in their territory.
3. At trade fairs, exhibitions, demonstrations or similar event s,
... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 35
shall be limited to the aspects of the procedure relating to en suring
sterility until the sterile packaging is opened or damaged. The natural
or legal person shall draw up a statement declaring that steril isation has
been carried out in accordance with the manufacture... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 35
shall be limited to the aspects of the procedure relating to en suring
sterility until the sterile packaging is opened or damaged. The natural
or legal person shall draw up a statement declaring that steril isation has
been carried out in accordance ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 36
CHAPTER III
IDENTIFICATION AND TRACEABILITY OF DEVICES,
REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS,
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE,
EUROPEAN DATABASE ON MEDICAL DEVICES
Article 25
Identification within the supply chain
1. Distributors and impor... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 36
CHAPTER III
IDENTIFICATION AND TRACEABILITY OF DEVICES,
REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS,
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE,
EUROPEAN DATABASE ON MEDICAL DEVICES
Article 25
Identification within the supply chain
1. Di... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 37
(ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of
device production and if applicable the packaged devices, as
specified in Part C of Annex VI;
(b) placing of the UDI on the label of the device or on its pac kaging;
(c) storage of the UDI by eco... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 37
(ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of
device production and if applicable the packaged devices, as
specified in Part C of Annex VI;
(b) placing of the UDI on the label of the device or on its pac kaging;
(c) stora... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 38
4. UDI carriers shall be placed on the label of the device and on all
higher levels of packaging. Higher levels of packaging shall no t be
understood to include shipping containers.
5. The UDI shall be used for reporting serious incidents and fi eld
safety corrective a... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 38
4. UDI carriers shall be placed on the label of the device and on all
higher levels of packaging. Higher levels of packaging shall no t be
understood to include shipping containers.
5. The UDI shall be used for reporting serious incidents and fi eld ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 39
The implementing acts referred to in the first subparagraph sha ll be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
12. When adopting the measures referred to in paragraph 11, the
Commission shall take into account all of the fol... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 39
The implementing acts referred to in the first subparagraph sha ll be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
12. When adopting the measures referred to in paragraph 11, the
Commission shall take into ac... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 40
2. Before placing on the market a system or procedure pack purs uant
to Article 22(1) and (3), that is not a custom-made device, the natural or
legal person responsible shall assign to the system or procedur e pack, in
compliance with the rules of the issuing entity, a ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 40
2. Before placing on the market a system or procedure pack purs uant
to Article 22(1) and (3), that is not a custom-made device, the natural or
legal person responsible shall assign to the system or procedur e pack, in
compliance with the rules of th... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 41
Article 31
Registration of manufacturers, authorised representatives and
importers
1. Before placing a device, other than a custom-made device, on the
market, manufacturers, authorised representatives and importers shall, in
order to register, submit to the electro... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 41
Article 31
Registration of manufacturers, authorised representatives and
importers
1. Before placing a device, other than a custom-made device, on the
market, manufacturers, authorised representatives and importers shall, in
order to register, s... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 42
The summary of safety and clinical performance shall be written in a
way that is clear to the intended user and, if relevant, to the patient and
shall be made available to the public via Eudamed.
The draft of the summary of safety and clinical performance sha ll be
p... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 42
The summary of safety and clinical performance shall be written in a
way that is clear to the intended user and, if relevant, to the patient and
shall be made available to the public via Eudamed.
The draft of the summary of safety and clinical perf... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 43
(b) to enable unique identification of devices within the inter nal market
and to facilitate their traceability;
(c) to enable the public to be adequately informed about clinic al inves
tigations and to enable sponsors of clinical investigations to comply
with obligati... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 43
(b) to enable unique identification of devices within the inter nal market
and to facilitate their traceability;
(c) to enable the public to be adequately informed about clinic al inves
tigations and to enable sponsors of clinical investigations to c... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 44
6. Eudamed shall contain personal data only insofar as necessar y for
the electronic systems referred to in paragraph 2 of this Artic le to collate
and process information in accordance with this Regulation. Per sonal
data shall be kept in a form which permits identifica... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 44
6. Eudamed shall contain personal data only insofar as necessar y for
the electronic systems referred to in paragraph 2 of this Artic le to collate
and process information in accordance with this Regulation. Per sonal
data shall be kept in a form whic... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 45
CHAPTER IV
NOTIFIED BODIES
Article 35
Authorities responsible for notified bodies
1. Any Member State that intends to designate a conformity
assessment body as a notified body, or has designated a notifie d
body, to carry out conformity assessment activities under... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 45
CHAPTER IV
NOTIFIED BODIES
Article 35
Authorities responsible for notified bodies
1. Any Member State that intends to designate a conformity
assessment body as a notified body, or has designated a notifie d
body, to carry out conformity assessm... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 46
Article 36
Requirements relating to notified bodies
1. Notified bodies shall fulfil the tasks for which they are de signated
in accordance with this Regulation. They shall satisfy the orga nisational
and general requirements and the quality management, resource a nd
... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 46
Article 36
Requirements relating to notified bodies
1. Notified bodies shall fulfil the tasks for which they are de signated
in accordance with this Regulation. They shall satisfy the orga nisational
and general requirements and the quality managem... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 47
5. Notified bodies shall keep at the disposal of the authority
responsible for notified bodies all relevant documents concerni ng the
verification of the qualifications of the subcontractor or the subsidiary
and the work carried out by them under this Regulation.
Artic... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 47
5. Notified bodies shall keep at the disposal of the authority
responsible for notified bodies all relevant documents concerni ng the
verification of the qualifications of the subcontractor or the subsidiary
and the work carried out by them under this... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 48
The joint assessment team shall be comprised of experts who are
competent to assess the conformity assessment activities and th e types
of devices which are the subject of the application or, in part icular when
the assessment procedure is initiated in accordance with A... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 48
The joint assessment team shall be comprised of experts who are
competent to assess the conformity assessment activities and th e types
of devices which are the subject of the application or, in part icular when
the assessment procedure is initiated ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 49
— the result of the assessment,
— confirmation that the corrective and preventive actions have been
appropriately addressed and, where required, implemented,
— any remaining diverging opinion with the joint assessment tea m,
and, where applicable,
— the recommended ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 49
— the result of the assessment,
— confirmation that the corrective and preventive actions have been
appropriately addressed and, where required, implemented,
— any remaining diverging opinion with the joint assessment tea m,
and, where applicable, ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 50
The Commission shall provide translations of the documentation
pursuant to Articles 38 and 39, or parts thereof into an offici al Union
language, such as is necessary for that documentation to be rea dily
understood by the joint assessment team appointed in accordance w... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 50
The Commission shall provide translations of the documentation
pursuant to Articles 38 and 39, or parts thereof into an offici al Union
language, such as is necessary for that documentation to be rea dily
understood by the joint assessment team appoin... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 51
8. Where the MDCG, after having been consulted in accordance wi th
paragraph 7, confirms the existing objection or raises another objection,
the notifying Member State shall provide a written response to the
MDCG opinion within 40 days of its receipt. The response shall ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 51
8. Where the MDCG, after having been consulted in accordance wi th
paragraph 7, confirms the existing objection or raises another objection,
the notifying Member State shall provide a written response to the
MDCG opinion within 40 days of its receipt.... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 52
Article 44
Monitoring and re-assessment of notified bodies
1. Notified bodies shall, without delay, and at the latest with in 15
days, inform the authority responsible for notified bodies of r elevant
changes which may affect their compliance with the requirements se... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 52
Article 44
Monitoring and re-assessment of notified bodies
1. Notified bodies shall, without delay, and at the latest with in 15
days, inform the authority responsible for notified bodies of r elevant
changes which may affect their compliance with ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 53
6. The monitoring of notified bodies conducted by the authority
responsible for notified bodies shall consider data arising fro m market
surveillance, vigilance and post-market surveillance to help gu ide its
activities.
The authority responsible for notified bodies s... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 53
6. The monitoring of notified bodies conducted by the authority
responsible for notified bodies shall consider data arising fro m market
surveillance, vigilance and post-market surveillance to help gu ide its
activities.
The authority responsible f... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 54
11. The Commission is empowered to adopt delegated acts in
accordance with Article 115 in order to amend paragraph 10 to
modify the frequency at which the complete re-assessment referr ed to
in that paragraph is to be carried out.
12. The Member States shall report to ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 54
11. The Commission is empowered to adopt delegated acts in
accordance with Article 115 in order to amend paragraph 10 to
modify the frequency at which the complete re-assessment referr ed to
in that paragraph is to be carried out.
12. The Member Sta... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 55
5. Based on the reports of the reviews and assessments by the
authority responsible for notified bodies or joint assessment t eams, on
input from the market surveillance, vigilance and post-market
surveillance activities described in Chapter VII, on the contin uous moni... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 55
5. Based on the reports of the reviews and assessments by the
authority responsible for notified bodies or joint assessment t eams, on
input from the market surveillance, vigilance and post-market
surveillance activities described in Chapter VII, on t... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 56
The authority responsible for notified bodies shall immediately inform
the Commission and the other Member States of any suspension,
restriction or withdrawal of a designation.
5. Where its designation has been suspended, restricted, or ful ly or
partially withdrawn, ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 56
The authority responsible for notified bodies shall immediately inform
the Commission and the other Member States of any suspension,
restriction or withdrawal of a designation.
5. Where its designation has been suspended, restricted, or ful ly or
p... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 57
(b) the authority responsible for notified bodies has confirmed that no
certificates relevant to the suspension will be issued, amended or
re-issued during the course of the suspension or restriction, a nd
states whether the notified body has the capability of continui... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 57
(b) the authority responsible for notified bodies has confirmed that no
certificates relevant to the suspension will be issued, amended or
re-issued during the course of the suspension or restriction, a nd
states whether the notified body has the ca... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 58
3. The Commission, in conjunction with the MDCG, may initiate, as
applicable, the assessment procedure described in Article 39(3) and (4),
where there is reasonable concern about the ongoing compliance of a
notified body or a subsidiary or subcontractor of the notified ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 58
3. The Commission, in conjunction with the MDCG, may initiate, as
applicable, the assessment procedure described in Article 39(3) and (4),
where there is reasonable concern about the ongoing compliance of a
notified body or a subsidiary or subcontrac... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 59
(e) monitoring of the application and applicability of scope co des
referred to in Article 42(13);
(f) development of a mechanism for peer reviews between authori ties
and the Commission;
(g) methods of communication to the public on the monitoring an d
surveillance ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 59
(e) monitoring of the application and applicability of scope co des
referred to in Article 42(13);
(f) development of a mechanism for peer reviews between authori ties
and the Commission;
(g) methods of communication to the public on the monitoring... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 60
Article 50
List of standard fees
Notified bodies shall establish lists of their standard fees fo r the
conformity assessment activities that they carry out and shall make
those lists publicly available.
CHAPTER V
CLASSIFICATION AND CONFORMITY ASSESSMENT
SECTION ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 60
Article 50
List of standard fees
Notified bodies shall establish lists of their standard fees fo r the
conformity assessment activities that they carry out and shall make
those lists publicly available.
CHAPTER V
CLASSIFICATION AND CONFORMITY A... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 61
5. In order to ensure the uniform application of Annex VIII, an d
taking account of the relevant scientific opinions of the relev ant
scientific committees, the Commission may adopt implementing ac ts
to the extent necessary to resolve issues of divergent interpre tation... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 61
5. In order to ensure the uniform application of Annex VIII, an d
taking account of the relevant scientific opinions of the relev ant
scientific committees, the Commission may adopt implementing ac ts
to the extent necessary to resolve issues of diver... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 62
5. Where justified in view of well-established technologies, si milar to
those used in the exempted devices listed in the second subpara graph of
paragraph 4 of this Article, being used in other class IIb impl antable
devices, or where justified in order to protect the h... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 62
5. Where justified in view of well-established technologies, si milar to
those used in the exempted devices listed in the second subpara graph of
paragraph 4 of this Article, being used in other class IIb impl antable
devices, or where justified in or... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 63
9. In addition to the procedures applicable pursuant to paragra ph 3,
4, 6, or 7 of this Article, in the case of devices referred to in the first
subparagraph of Article 1(8), the procedure specified in Sectio n 5.2 of
Annex IX or Section 6 of Annex X, as applicable, sha... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 63
9. In addition to the procedures applicable pursuant to paragra ph 3,
4, 6, or 7 of this Article, in the case of devices referred to in the first
subparagraph of Article 1(8), the procedure specified in Sectio n 5.2 of
Annex IX or Section 6 of Annex X... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 64
The implementing acts referred to in the first subparagraph sha ll be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
Article 53
Involvement of notified bodies in conformity assessment procedures
1. Where the conformity assessmen... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 64
The implementing acts referred to in the first subparagraph sha ll be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
Article 53
Involvement of notified bodies in conformity assessment procedures
1. Where the ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 65
2. The procedure referred to in paragraph 1 shall not be requir ed for
the devices referred to therein:
(a) in the case of renewal of a certificate issued under this R egulation;
(b) where the device has been designed by modifying a device al ready
marketed by the sam... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 65
2. The procedure referred to in paragraph 1 shall not be requir ed for
the devices referred to therein:
(a) in the case of renewal of a certificate issued under this R egulation;
(b) where the device has been designed by modifying a device al ready ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 66
2. A competent authority and, where applicable, the Commission
may, based on reasonable concerns apply further procedures in
accordance with Article 44, 45, 46, 47 or 94 and, where deemed
necessary, take appropriate measures in accordance with Article s 95
and 97.
3. ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 66
2. A competent authority and, where applicable, the Commission
may, based on reasonable concerns apply further procedures in
accordance with Article 44, 45, 46, 47 or 94 and, where deemed
necessary, take appropriate measures in accordance with Article... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 67
(a) the list of subsidiaries referred to in Article 37(3);
(b) the list of experts referred to in Article 40(2);
(c) the information relating to the notification referred to in
Article 42(10) and the amended notifications referred to in
Article 46(2);
(d) the list ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 67
(a) the list of subsidiaries referred to in Article 37(3);
(b) the list of experts referred to in Article 40(2);
(c) the information relating to the notification referred to in
Article 42(10) and the amended notifications referred to in
Article 46... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 68
2. The outgoing notified body shall withdraw the certificates i t has
issued for the device concerned on the date on which they becom e
invalid.
Article 59
Derogation from the conformity assessment procedures
▼M1
1. By way of derogation from Article 52 of this Regul... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 68
2. The outgoing notified body shall withdraw the certificates i t has
issued for the device concerned on the date on which they becom e
invalid.
Article 59
Derogation from the conformity assessment procedures
▼M1
1. By way of derogation from Arti... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 69
the CE marking in accordance with this Regulation may be market ed in
the Union. The certificate of free sale shall set out the Basic UDI-DI of
the device as provided to the UDI database under Article 29. Wh ere a
notified body has issued a certificate pursuant to Artic... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 69
the CE marking in accordance with this Regulation may be market ed in
the Union. The certificate of free sale shall set out the Basic UDI-DI of
the device as provided to the UDI database under Article 29. Wh ere a
notified body has issued a certifica... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 70
— it is demonstrated that the device subject to clinical evalua tion
for the intended purpose is equivalent to the device to which t he
data relate, in accordance with Section 3 of Annex XIV, and
— the data adequately demonstrate compliance with the relevant
general sa... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 70
— it is demonstrated that the device subject to clinical evalua tion
for the intended purpose is equivalent to the device to which t he
data relate, in accordance with Section 3 of Annex XIV, and
— the data adequately demonstrate compliance with the ... |
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(b) that are sutures, staples, dental fillings, dental braces, tooth crowns,
screws, wedges, plates, wires, pins, clips or connectors for wh ich
the clinical evaluation is based on sufficient clinical data an d is in
compliance with the relevant product-specific CS, wher... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 71
(b) that are sutures, staples, dental fillings, dental braces, tooth crowns,
screws, wedges, plates, wires, pins, clips or connectors for wh ich
the clinical evaluation is based on sufficient clinical data an d is in
compliance with the relevant produ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 72
12. The clinical evaluation, its results and the clinical evide nce
derived from it shall be documented in a clinical evaluation re port as
referred to in Section 4 of Annex XIV, which, except for custom -made
devices, shall be part of the technical documentation referre... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 72
12. The clinical evaluation, its results and the clinical evide nce
derived from it shall be documented in a clinical evaluation re port as
referred to in Section 4 of Annex XIV, which, except for custom -made
devices, shall be part of the technical d... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 73
3. Clinical investigations shall be designed and conducted in s uch a
way that the rights, safety, dignity and well-being of the subj ects par
ticipating in a clinical investigation are protected and prevai l over all
other interests and the clinical data generated are s... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 73
3. Clinical investigations shall be designed and conducted in s uch a
way that the rights, safety, dignity and well-being of the subj ects par
ticipating in a clinical investigation are protected and prevai l over all
other interests and the clinical ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 74
(k) no undue influence, including that of a financial nature, i s exerted
on the subject, or, where applicable, on his or her legally
designated representatives, to participate in the clinical
investigation;
(l) the investigational device(s) in question conform(s) to t... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 74
(k) no undue influence, including that of a financial nature, i s exerted
on the subject, or, where applicable, on his or her legally
designated representatives, to participate in the clinical
investigation;
(l) the investigational device(s) in ques... |
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2. Information given to the subject or, where the subject is no t able
to give informed consent, his or her legally designated represe ntative for
the purposes of obtaining his or her informed consent shall:
(a) enable the subject or his or her legally designated repres... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 75
2. Information given to the subject or, where the subject is no t able
to give informed consent, his or her legally designated represe ntative for
the purposes of obtaining his or her informed consent shall:
(a) enable the subject or his or her legal... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 76
7. This Regulation is without prejudice to national law requiri ng that,
in addition to the informed consent given by the legally design ated
representative, a minor who is capable of forming an opinion an d
assessing the information given to him or her, shall also assen... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 76
7. This Regulation is without prejudice to national law requiri ng that,
in addition to the informed consent given by the legally design ated
representative, a minor who is capable of forming an opinion an d
assessing the information given to him or h... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 77
(b) the minors have received the information referred to in Art icle 63(2)
in a way adapted to their age and mental maturity and from inve s
tigators or members of the investigating team who are trained o r
experienced in working with children;
(c) the explicit wish of... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 77
(b) the minors have received the information referred to in Art icle 63(2)
in a way adapted to their age and mental maturity and from inve s
tigators or members of the investigating team who are trained o r
experienced in working with children;
(c) ... |
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Article 67
Additional national measures
Member States may maintain additional measures regarding person s
performing mandatory military service, persons deprived of libe rty,
persons who, due to a judicial decision, cannot take part in cl inical
investigations, or pe... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 78
Article 67
Additional national measures
Member States may maintain additional measures regarding person s
performing mandatory military service, persons deprived of libe rty,
persons who, due to a judicial decision, cannot take part in cl inical
i... |
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(a) regarding incapacitated subjects and minors, the informed c onsent
shall be sought by the investigator from his or her legally
designated representative without undue delay and the informati on
referred to in Article 63(2) shall be given as soon as possible to the
... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 79
(a) regarding incapacitated subjects and minors, the informed c onsent
shall be sought by the investigator from his or her legally
designated representative without undue delay and the informati on
referred to in Article 63(2) shall be given as soon a... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 80
3. Where the Member State concerned finds that the clinical inv es
tigation applied for does not fall within the scope of this Reg ulation or
that the application dossier is not complete, it shall inform t he sponsor
thereof and shall set a time limit of maximum 10 days ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 80
3. Where the Member State concerned finds that the clinical inv es
tigation applied for does not fall within the scope of this Reg ulation or
that the application dossier is not complete, it shall inform t he sponsor
thereof and shall set a time limit... |
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8. The Commission is empowered to adopt delegated acts in
accordance with Article 115 amending, in the light of technical
progress and global regulatory developments, the requirements l aid
down in Chapter II of Annex XV.
9. In order to ensure the uniform application ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 81
8. The Commission is empowered to adopt delegated acts in
accordance with Article 115 amending, in the light of technical
progress and global regulatory developments, the requirements l aid
down in Chapter II of Annex XV.
9. In order to ensure the ... |
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(f) in the case of devices for sterile use, evidence of the val idation of
the manufacturer's sterilisation procedures or information on t he
reconditioning and sterilisation procedures which have to be
conducted by the investigation site;
(g) the demonstration of the ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 82
(f) in the case of devices for sterile use, evidence of the val idation of
the manufacturer's sterilisation procedures or information on t he
reconditioning and sterilisation procedures which have to be
conducted by the investigation site;
(g) the d... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 83
5. Member States shall inspect, at an appropriate level, invest igation
site(s) to check that clinical investigations are conducted in accordance
with the requirements of this Regulation and with the approved inves
tigation plan.
6. The sponsor shall establish a proced... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 83
5. Member States shall inspect, at an appropriate level, invest igation
site(s) to check that clinical investigations are conducted in accordance
with the requirements of this Regulation and with the approved inves
tigation plan.
6. The sponsor shal... |
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(c) effective supervision of the conduct of the clinical invest igation by
the Member State(s) concerned.
4. No personal data of subjects shall be publicly available.
5. The user interface of the electronic system referred to in
paragraph 1 shall be available in all o... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 84
(c) effective supervision of the conduct of the clinical invest igation by
the Member State(s) concerned.
4. No personal data of subjects shall be publicly available.
5. The user interface of the electronic system referred to in
paragraph 1 shall b... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 85
(b) an ethics committee in that Member State has issued a negat ive
opinion in relation to the substantial modification to the clin ical
investigation, which, in accordance with national law, is valid for
that entire Member State.
4. The Member State(s) concerned may ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 85
(b) an ethics committee in that Member State has issued a negat ive
opinion in relation to the substantial modification to the clin ical
investigation, which, in accordance with national law, is valid for
that entire Member State.
4. The Member Sta... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 86
3. The sponsor shall notify each Member State in which a clinic al
investigation was being conducted of the end of that clinical i nvesti
gation in that Member State. That notification shall be made wi thin 15
days of the end of the clinical investigation in relation to ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 86
3. The sponsor shall notify each Member State in which a clinic al
investigation was being conducted of the end of that clinical i nvesti
gation in that Member State. That notification shall be made wi thin 15
days of the end of the clinical investiga... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 87
2. The sponsor shall propose in the single application referred to in
paragraph 1 that one of the Member States in which the clinical inves
tigation is to be conducted acts as coordinating Member State. The
Member States in which the clinical investigation is to be con... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 87
2. The sponsor shall propose in the single application referred to in
paragraph 1 that one of the Member States in which the clinical inves
tigation is to be conducted acts as coordinating Member State. The
Member States in which the clinical invest... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 88
6. For class IIb and class III devices, the coordinating Member State
may also extend the periods referred to in paragraph 4 by a fur ther 50
days, for the purpose of consulting with experts.
7. The Commission may, by means of implementing acts, further
specify the pr... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 88
6. For class IIb and class III devices, the coordinating Member State
may also extend the periods referred to in paragraph 4 by a fur ther 50
days, for the purpose of consulting with experts.
7. The Commission may, by means of implementing acts, fur... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 89
11. Each Member State concerned shall notify the sponsor throug h
the electronic system referred to in Article 73 as to whether t he clinical
investigation is authorised, whether it is authorised subject t o conditions,
or whether authorisation has been refused. Notifica... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 89
11. Each Member State concerned shall notify the sponsor throug h
the electronic system referred to in Article 73 as to whether t he clinical
investigation is authorised, whether it is authorised subject t o conditions,
or whether authorisation has be... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 90
2. The sponsor shall report, without delay to all Member States in
which the clinical investigation is being conducted, all of the following
by means of the electronic system referred to in Article 73:
(a) any serious adverse event that has a causal relationship wi th... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 90
2. The sponsor shall report, without delay to all Member States in
which the clinical investigation is being conducted, all of the following
by means of the electronic system referred to in Article 73:
(a) any serious adverse event that has a causa... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 91
Article 81
Implementing acts
The Commission may, by means of implementing acts, establish th e
detailed arrangements and procedural aspects necessary for the im
plementation of this Chapter as regards the following:
(a) harmonised electronic forms for the applicatio... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 91
Article 81
Implementing acts
The Commission may, by means of implementing acts, establish th e
detailed arrangements and procedural aspects necessary for the im
plementation of this Chapter as regards the following:
(a) harmonised electronic form... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 92
CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET
SURVEILLANCE
SECTION 1
Post-market surveillance
Article 83
Post-market surveillance system of the manufacturer
1. For each device, manufacturers shall plan, establish, docume nt,
implement, maintain an... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 92
CHAPTER VII
POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET
SURVEILLANCE
SECTION 1
Post-market surveillance
Article 83
Post-market surveillance system of the manufacturer
1. For each device, manufacturers shall plan, establish, docume nt,
im... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 93
4. If, in the course of the post-market surveillance, a need fo r
preventive or corrective action or both is identified, the manu facturer
shall implement the appropriate measures and inform the compete nt
authorities concerned and, where applicable, the notified body. ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 93
4. If, in the course of the post-market surveillance, a need fo r
preventive or corrective action or both is identified, the manu facturer
shall implement the appropriate measures and inform the compete nt
authorities concerned and, where applicable, ... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 94
Manufacturers of class IIa devices shall update the PSUR when
necessary and at least every two years. That PSUR shall, except in
the case of custom-made devices, be part of the technical docum entation
as specified in Annexes II and III.
For custom-made devices, the P... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 94
Manufacturers of class IIa devices shall update the PSUR when
necessary and at least every two years. That PSUR shall, except in
the case of custom-made devices, be part of the technical docum entation
as specified in Annexes II and III.
For custom... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 95
3. Manufacturers shall report any serious incident as referred to in
point (a) of paragraph 1 immediately after they have establishe d the
causal relationship between that incident and their device or t hat such
causal relationship is reasonably possible and not later th... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 95
3. Manufacturers shall report any serious incident as referred to in
point (a) of paragraph 1 immediately after they have establishe d the
causal relationship between that incident and their device or t hat such
causal relationship is reasonably possi... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 96
Where the manufacturer of the device concerned considers that t he
incident is a serious incident, it shall provide a report in ac cordance
with paragraphs 1 to 5 of this Article on that serious incident to the
competent authority of the Member State in which that serio... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 96
Where the manufacturer of the device concerned considers that t he
incident is a serious incident, it shall provide a report in ac cordance
with paragraphs 1 to 5 of this Article on that serious incident to the
competent authority of the Member State... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 97
The manufacturer shall co-operate with the competent authoritie s and
where relevant with the notified body concerned during the inve sti
gations referred to in the first subparagraph and shall not per form any
investigation which involves altering the device or a sample... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 97
The manufacturer shall co-operate with the competent authoritie s and
where relevant with the notified body concerned during the inve sti
gations referred to in the first subparagraph and shall not per form any
investigation which involves altering th... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 98
In the case of devices covered by this Regulation in accordance with
point (g) of Article 1(6) and where the serious incident or fie ld safety
corrective action may be related to the derivatives of tissues or cells of
human origin utilised for the manufacture of the dev... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 98
In the case of devices covered by this Regulation in accordance with
point (g) of Article 1(6) and where the serious incident or fie ld safety
corrective action may be related to the derivatives of tissues or cells of
human origin utilised for the ma... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 99
(b) where the appropriateness of a field safety corrective acti on that is
proposed by a manufacturer in more than one Member State is in
question.
That coordinated procedure shall cover the following:
— designation of a coordinating competent authority on a case b y ... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 99
(b) where the appropriateness of a field safety corrective acti on that is
proposed by a manufacturer in more than one Member State is in
question.
That coordinated procedure shall cover the following:
— designation of a coordinating competent auth... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 — EN — 10.01.2025 — 005.001 — 100
(b) the reporting of serious incidents and field safety correct ive actions
and field safety notices, and the provision of periodic summary
reports, post-market surveillance reports, PSURs and trend repo rts
by manufacturers as referred to in Articles 85, 86, 87, 88 an... | Summary: 02017R0745 — EN — 10.01.2025 — 005.001 — 100
(b) the reporting of serious incidents and field safety correct ive actions
and field safety notices, and the provision of periodic summary
reports, post-market surveillance reports, PSURs and trend repo rts
by manufacturers as referred to in Articl... |
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