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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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 6
and which does not achieve its principal intended action by pha rΒ
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:
β dev... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 6
and which does not achieve its principal intended action by pha rΒ
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 β EN β 10.01.2025 β 005.001 β 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) βinvasive deviceβ means any device which, in whole... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 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) βinvasive deviceβ means any de... |
Define the key term or concept related to medical device regulation. | 02017R0745 β EN β 10.01.2025 β 005.001 β 8
(18) βnanomaterialβ 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 β EN β 10.01.2025 β 005.001 β 8
(18) βnanomaterialβ 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 β EN β 10.01.2025 β 005.001 β 9
(27) βmaking available on the marketβ 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) βplacing o... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 9
(27) βmaking available on the marketβ 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 β EN β 10.01.2025 β 005.001 β 10
(40) βconformity assessmentβ means the process demonstrating wh ether
the requirements of this Regulation relating to a device have b een
fulfilled;
(41) βconformity assessment bodyβ means a body that performs
third-party conformity assessment activities including cali... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 10
(40) βconformity assessmentβ means the process demonstrating wh ether
the requirements of this Regulation relating to a device have b een
fulfilled;
(41) βconformity assessment bodyβ means a body that performs
third-party conformity assessment activ... |
Define the key term or concept related to medical device regulation. | 02017R0745 β EN β 10.01.2025 β 005.001 β 11
(51) βclinical evidenceβ 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 β EN β 10.01.2025 β 005.001 β 11
(51) βclinical evidenceβ 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 β EN β 10.01.2025 β 005.001 β 12
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or m ental
impairment or birth defect;
(59) βdevice deficiencyβ means any inadequacy in the identity, quality,
durability, reliability, safety or performance of an investigat ional
device... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 12
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or m ental
impairment or birth defect;
(59) βdevice deficiencyβ 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 β EN β 10.01.2025 β 005.001 β 13
(68) βfield safety corrective actionβ 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) βfield safety noticeβ means a commun... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 13
(68) βfield safety corrective actionβ 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) βfield safety no... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 PharΒ
macopoeia, in particular on surgical sutures and on interaction bet... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 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 PharΒ
macopoeia, in particular on surgical sutures and... |
Summarize the content of the article and explain its significance in medical device regulation. | 02017R0745 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 20
Where the device presents a serious risk, manufacturers shall i mmediΒ
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 β EN β 10.01.2025 β 005.001 β 20
Where the device presents a serious risk, manufacturers shall i mmediΒ
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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 22
2. The designation shall constitute the authorised representati ve's
mandate, it shall be valid only when accepted in writing by the authΒ
orised representative and shall be effective at least for all d evices of the
same generic device group.
3. The authorised represe... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 22
2. The designation shall constitute the authorised representati ve's
mandate, it shall be valid only when accepted in writing by the authΒ
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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 31
6. Only single-use devices that have been placed on the market in
accordance with this Regulation, or prior to βΊM1 26 May 2021 β 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 β EN β 10.01.2025 β 005.001 β 31
6. Only single-use devices that have been placed on the market in
accordance with this Regulation, or prior to βΊM1 26 May 2021 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 37
(ii) a UDI production identifier (βUDI-PIβ) 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 β EN β 10.01.2025 β 005.001 β 37
(ii) a UDI production identifier (βUDI-PIβ) 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 invesΒ
tigations and to enable sponsors of clinical investigations to comply
with obligati... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 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 invesΒ
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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 49
β the result of the assessment,
β confirmation that the corrective and preventive actions have been
appropriately addressed and, where required, implemented,
β any remaining diverging opinion with the joint assessment tea m,
and, where applicable,
β the recommended ... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 49
β the result of the assessment,
β confirmation that the corrective and preventive actions have been
appropriately addressed and, where required, implemented,
β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 moniΒ... | Summary: 02017R0745 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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 β EN β 10.01.2025 β 005.001 β 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... |
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