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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 official texts are directly accessible through the links
embedded in this document
►B 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 with EEA relevance)
(OJ L 117, 5.5.2017, p. 1)
Amended by:
Official Journal
No page date
►M1 Regulation (EU) 2020/561 of the European Parliament and of the
Council of 23 April 2020 L 130 1 8 24.4.2020
►M2 Commission Delegated Regulation (EU) 2023/502 of 1 December 20 22 L 7 0 1 8.3.2023
►M3 Regulation (EU) 2023/607 of the European Parliament and of the
Council of 15 March 2023 L 80 2 4 20.3.2023
►M4 Regulation (EU) 2024/568 of the European Parliament and of the
Council of 7 February 2024 L 568 1 14.2.2024
►M5 Regulation (EU) 2024/1860 of the European Parliament and of th e
Council of 13 June 2024 L 1860 1 9.7.2024
Corrected by:
►C1 Corrigendum, OJ L 117, 3.5.2019, p. 9 (2017/745)
►C2 Corrigendum, OJ L 334, 27.12.2019, p. 165 (2017/745) 02017R0745 — EN — 10.01.2025 — 005.001 — 1 | 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 with EEA relevance)
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
1. This Regulation lays down rules concerning the placing on th e
market, making available on the market or putting into service of
medical devices for human use and accessories for such devices in
the Union. This Regulation also applies to clinical investigati ons
concerning such medical devices and accessories conducted in th e
Union.
2. This Regulation shall also apply, as from the date of applic ation of
common specifications adopted pursuant to Article 9, to the gro ups of
products without an intended medical purpose that are listed in
Annex XVI, taking into account the state of the art, and in par ticular
existing harmonised standards for analogous devices with a medi cal
purpose, based on similar technology. The common specifications for
each of the groups of products listed in Annex XVI shall addres s, at
least, application of risk management as set out in Annex I for the
group of products in question and, where necessary, clinical ev aluation
regarding safety.
The necessary common specifications shall be adopted by
►M1 26 May 2021 ◄. They shall apply as from six months after
the date of their entry into force or from ►M1 26 May 2021 ◄,
whichever is the latest.
Notwithstanding Article 122, Member States' measures regarding the
qualification of the products covered by Annex XVI as medical
devices pursuant to Directive 93/42/EEC shall remain valid unti l the
date of application, as referred to in the first subparagraph, of the
relevant common specifications for that group of products.
This Regulation also applies to clinical investigations conduct ed in the
Union concerning the products referred to in the first subparag raph.
3. Devices with both a medical and a non-medical intended purpo se
shall fulfil cumulatively the requirements applicable to device s with an
intended medical purpose and those applicable to devices withou t an
intended medical purpose.
4. For the purposes of this Regulation, medical devices, access ories
for medical devices, and products listed in Annex XVI to which this
Regulation applies pursuant to paragraph 2 shall hereinafter be referred
to as ‘devices’. ▼B | 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
accordance with Article 115 to amend the list in Annex XVI, by
adding new groups of products, in order to protect the health a nd
safety of users or other persons or other aspects of public hea lth.
6. This Regulation does not apply to:
(a) in vitro diagnostic medical devices covered by Regu
lation (EU) 2017/746;
(b) medicinal products as defined in point 2 of Article 1 of
Directive 2001/83/EC. In deciding whether a product falls under
Directive 2001/83/EC or under this Regulation, particular accou nt
shall be taken of the principal mode of action of the product;
(c) advanced therapy medicinal products covered by Regu
lation (EC) No 1394/2007;
(d) human blood, blood products, plasma or blood cells of human
origin or devices which incorporate, when placed on the market
or put into service, such blood products, plasma or cells, exce pt
for devices referred to in paragraph 8 of this Article;
(e) cosmetic products covered by Regulation (EC) No 1223/2009;
(f) transplants, tissues or cells of animal origin, or their de rivatives, or
products containing or consisting of them; however this Regulat ion
does apply to devices manufactured utilising tissues or cells o f
animal origin, or their derivatives, which are non-viable or ar e
rendered non-viable;
(g) transplants, tissues or cells of human origin, or their der ivatives,
covered by Directive 2004/23/EC, or products containing or
consisting of them; however this Regulation does apply to devic es
manufactured utilising derivatives of tissues or cells of human
origin which are non-viable or are rendered non-viable;
(h) products, other than those referred to in points (d), (f) a nd (g), that
contain or consist of viable biological material or viable orga nisms,
including living micro-organisms, bacteria, fungi or viruses in order
to achieve or support the intended purpose of the product;
(i) food covered by Regulation (EC) No 178/2002.
7. Any device which, when placed on the market or put into serv ice,
incorporates as an integral part an in vitro diagnostic medical device as
defined in point 2 of Article 2 of Regulation (EU) 2017/746, sh all be
governed by this Regulation. The requirements of Regu
lation (EU) 2017/746 shall apply to the in vitro diagnostic medical
device part of the device. ▼B | 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 produc t
derived from human blood or human plasma as defined in point 10
of Article 1 of that Directive, and that has an action ancillar y to that
of the device, shall be assessed and authorised in accordance w ith this
Regulation.
However, if the action of that substance is principal and not a ncillary to
that of the device, the integral product shall be governed by
Directive 2001/83/EC or Regulation (EC) No 726/2004 of the
European Parliament and of the Council ( 1 ), as applicable. In that
case, the relevant general safety and performance requirements set out
in Annex I to this Regulation shall apply as far as the safety and
performance of the device part are concerned.
9. Any device which is intended to administer a medicinal produ ct as
defined in point 2 of Article 1 of Directive 2001/83/EC shall b e
governed by this Regulation, without prejudice to the provision s of
that Directive and of Regulation (EC) No 726/2004 with regard t o
the medicinal product.
However, if the device intended to administer a medicinal produ ct and
the medicinal product are placed on the market in such a way th at they
form a single integral product which is intended exclusively fo r use in
the given combination and which is not reusable, that single in tegral
product shall be governed by Directive 2001/83/EC or Regu
lation (EC) No 726/2004, as applicable. In that case, the relev ant
general safety and performance requirements set out in Annex I to
this Regulation shall apply as far as the safety and performanc e of
the device part of the single integral product are concerned.
10. Any device which, when placed on the market or put into
service, incorporates, as an integral part, non-viable tissues or cells of
human origin or their derivatives that have an action ancillary to that of
the device shall be assessed and authorised in accordance with this
Regulation. In that case, the provisions for donation, procurem ent and
testing laid down in Directive 2004/23/EC shall apply.
However, if the action of those tissues or cells or their deriv atives is
principal and not ancillary to that of the device and the produ ct is not
governed by Regulation (EC) No 1394/2007, the product shall be
governed by Directive 2004/23/EC. In that case, the relevant ge neral
safety and performance requirements set out in Annex I to this Regu
lation shall apply as far as the safety and performance of the device part
are concerned.
11. This Regulation is specific Union legislation within the me aning
of Article 2(3) of Directive 2014/30/EU. ▼B
( 1 ) Regulation (EC) No 726/2004 of the European Parliament and of the Council
of 31 March 2004 laying down Community procedures for the autho risation
and supervision of medicinal products for human and veterinary use and
establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). | 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 ealth and
safety requirements set out in Annex I to that Directive to the extent to
which those requirements are more specific than the general saf ety and
performance requirements set out in Chapter II of Annex I to th is
Regulation.
13. This Regulation shall not affect the application of
Directive 2013/59/Euratom.
14. This Regulation shall not affect the right of a Member Stat e to
restrict the use of any specific type of device in relation to aspects not
covered by this Regulation.
15. This Regulation shall not affect national law concerning th e
organisation, delivery or financing of health services and medi cal
care, such as the requirement that certain devices may only be
supplied on a medical prescription, the requirement that only c ertain
health professionals or healthcare institutions may dispense or use
certain devices or that their use be accompanied by specific pr ofessional
counselling.
16. Nothing in this Regulation shall restrict the freedom of th e press
or the freedom of expression in the media in so far as those fr eedoms
are guaranteed in the Union and in the Member States, in partic ular
under Article 11 of the Charter of Fundamental Rights of the Eu ropean
Union.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
(1) ‘medical device’ means any instrument, apparatus, appliance ,
software, implant, reagent, material or other article intended by
the manufacturer to be used, alone or in combination, for human
beings for one or more of the following specific medical purpos es:
— diagnosis, prevention, monitoring, prediction, prognosis,
treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compen
sation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of
a physiological or pathological process or state,
— providing information by means of in vitro examination of
specimens derived from the human body, including organ,
blood and tissue donations, ▼B
( 1 ) Directive 2006/42/EC of the European Parliament and of the Co uncil of
17 May 2006 on machinery, and amending Directive 95/16/EC (OJ L 157,
9.6.2006, p. 24). | 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:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or
sterilisation of devices as referred to in Article 1(4) and of
those referred to in the first paragraph of this point.
(2) ‘accessory for a medical device’ means an article which, wh ilst not
being itself a medical device, is intended by its manufacturer to be
used together with one or several particular medical device(s) to
specifically enable the medical device(s) to be used in accorda nce
with its/their intended purpose(s) or to specifically and direc tly
assist the medical functionality of the medical device(s) in te rms
of its/their intended purpose(s);
(3) ‘custom-made device’ means any device specifically made in
accordance with a written prescription of any person authorised
by national law by virtue of that person's professional qualifi
cations which gives, under that person's responsibility, specif ic
design characteristics, and is intended for the sole use of a
particular patient exclusively to meet their individual conditi ons
and needs.
However, mass-produced devices which need to be adapted to
meet the specific requirements of any professional user and
devices which are mass-produced by means of industrial manu
facturing processes in accordance with the written prescription s of
any authorised person shall not be considered to be custom-made
devices;
(4) ‘active device’ means any device, the operation of which de pends
on a source of energy other than that generated by the human bo dy
for that purpose, or by gravity, and which acts by changing the
density of or converting that energy. Devices intended to trans mit
energy, substances or other elements between an active device a nd
the patient, without any significant change, shall not be deeme d to
be active devices.
Software shall also be deemed to be an active device;
(5) ‘implantable device’ means any device, including those that are
partially or wholly absorbed, which is intended:
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye,
by clinical intervention and which is intended to remain in pla ce
after the procedure. ▼B | 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 or in pa rt,
penetrates inside the body, either through a body orifice or th rough
the surface of the body;
(7) ‘generic device group’ means a set of devices having the sa me or
similar intended purposes or a commonality of technology
allowing them to be classified in a generic manner not reflecti ng
specific characteristics;
(8) ‘single-use device’ means a device that is intended to be u sed on
one individual during a single procedure;
(9) ‘falsified device’ means any device with a false presentati on of its
identity and/or of its source and/or its CE marking certificate s or
documents relating to CE marking procedures. This definition do es
not include unintentional non-compliance and is without prejudi ce
to infringements of intellectual property rights;
(10) ‘procedure pack’ means a combination of products packaged
together and placed on the market with the purpose of being
used for a specific medical purpose;
(11) ‘system’ means a combination of products, either packaged
together or not, which are intended to be inter-connected or
combined to achieve a specific medical purpose;
(12) ‘intended purpose’ means the use for which a device is int ended
according to the data supplied by the manufacturer on the label , in
the instructions for use or in promotional or sales materials o r
statements and as specified by the manufacturer in the clinical
evaluation;
(13) ‘label’ means the written, printed or graphic information appearing
either on the device itself, or on the packaging of each unit o r on
the packaging of multiple devices;
(14) ‘instructions for use’ means the information provided by t he manu
facturer to inform the user of a device's intended purpose and
proper use and of any precautions to be taken;
(15) ‘Unique Device Identifier’ (‘UDI’) means a series of numer ic or
alphanumeric characters that is created through internationally
accepted device identification and coding standards and that
allows unambiguous identification of specific devices on the
market;
(16) ‘non-viable’ means having no potential for metabolism or
multiplication;
(17) ‘derivative’ means a ‘non-cellular substance’ extracted fr om human
or animal tissue or cells through a manufacturing process. The
final substance used for manufacturing of the device in this ca se
does not contain any cells or tissues; ▼B | 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 the size range 1-100 nm;
Fullerenes, graphene flakes and single-wall carbon nanotubes wi th
one or more external dimensions below 1 nm shall also be deemed
to be nanomaterials;
(19) ‘particle’, for the purposes of the definition of nanomate rial in
point (18), means a minute piece of matter with defined physica l
boundaries;
(20) ‘agglomerate’, for the purposes of the definition of nanom aterial in
point (18), means a collection of weakly bound particles or
aggregates where the resulting external surface area is similar to
the sum of the surface areas of the individual components;
(21) ‘aggregate’, for the purposes of the definition of nanomat erial in
point (18), means a particle comprising of strongly bound or fu sed
particles;
(22) ‘performance’ means the ability of a device to achieve its intended
purpose as stated by the manufacturer;
(23) ‘risk’ means the combination of the probability of occurre nce of
harm and the severity of that harm;
(24) ‘benefit-risk determination’ means the analysis of all ass essments
of benefit and risk of possible relevance for the use of the de vice
for the intended purpose, when used in accordance with the
intended purpose given by the manufacturer;
(25) ‘compatibility’ is the ability of a device, including soft ware, when
used together with one or more other devices in accordance with
its intended purpose, to:
(a) perform without losing or compromising the ability to perfo rm
as intended, and/or
(b) integrate and/or operate without the need for modification or
adaption of any part of the combined devices, and/or
(c) be used together without conflict/interference or adverse
reaction.
(26) ‘interoperability’ is the ability of two or more devices, including
software, from the same manufacturer or from different manu
facturers, to:
(a) exchange information and use the information that has been
exchanged for the correct execution of a specified function
without changing the content of the data, and/or
(b) communicate with each other, and/or
(c) work together as intended. ▼B | 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 on the market’ means the first making available o f a
device, other than an investigational device, on the Union mark et;
(29) ‘putting into service’ means the stage at which a device, other than
an investigational device, has been made available to the final user
as being ready for use on the Union market for the first time f or its
intended purpose;
▼C1
(30) ‘manufacturer’ means a natural or legal person who manufac tures
or fully refurbishes a device or has a device designed, manu
factured or fully refurbished, and markets that device under it s
name or trade mark;
▼B
(31) ‘fully refurbishing’, for the purposes of the definition o f manu
facturer, means the complete rebuilding of a device already pla ced
on the market or put into service, or the making of a new devic e
from used devices, to bring it into conformity with this Regula tion,
combined with the assignment of a new lifetime to the refurbish ed
device;
(32) ‘authorised representative’ means any natural or legal per son estab
lished within the Union who has received and accepted a written
mandate from a manufacturer, located outside the Union, to act on
the manufacturer's behalf in relation to specified tasks with r egard
to the latter's obligations under this Regulation;
(33) ‘importer’ means any natural or legal person established w ithin the
Union that places a device from a third country on the Union
market;
(34) ‘distributor’ means any natural or legal person in the sup ply chain,
other than the manufacturer or the importer, that makes a devic e
available on the market, up until the point of putting into ser vice;
(35) ‘economic operator’ means a manufacturer, an authorised re presen
tative, an importer, a distributor or the person referred to in
Article 22(1) and 22(3);
(36) ‘health institution’ means an organisation the primary pur pose of
which is the care or treatment of patients or the promotion of
public health;
(37) ‘user’ means any healthcare professional or lay person who uses a
device;
(38) ‘lay person’ means an individual who does not have formal
education in a relevant field of healthcare or medical discipli ne;
(39) ‘reprocessing’ means a process carried out on a used devic e in
order to allow its safe reuse including cleaning, disinfection, ster
ilisation and related procedures, as well as testing and restor ing the
technical and functional safety of the used device; ▼B | 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 calibrat ion,
testing, certification and inspection;
(42) ‘notified body’ means a conformity assessment body designa ted in
accordance with this Regulation;
(43) ‘CE marking of conformity’ or ‘CE marking’ means a marking by
which a manufacturer indicates that a device is in conformity w ith
the applicable requirements set out in this Regulation and othe r
applicable Union harmonisation legislation providing for its
affixing;
(44) ‘clinical evaluation’ means a systematic and planned proce ss to
continuously generate, collect, analyse and assess the clinical
data pertaining to a device in order to verify the safety and
performance, including clinical benefits, of the device when us ed
as intended by the manufacturer;
(45) ‘clinical investigation’ means any systematic investigatio n
involving one or more human subjects, undertaken to assess the
safety or performance of a device;
(46) ‘investigational device’ means a device that is assessed i n a
clinical investigation;
(47) ‘clinical investigation plan’ means a document that descri bes the
rationale, objectives, design, methodology, monitoring, statist ical
considerations, organisation and conduct of a clinical investig ation;
(48) ‘clinical data’ means information concerning safety or per formance
that is generated from the use of a device and is sourced from the
following:
— clinical investigation(s) of the device concerned,
— clinical investigation(s) or other studies reported in scient ific
literature, of a device for which equivalence to the device in
question can be demonstrated,
— reports published in peer reviewed scientific literature on o ther
clinical experience of either the device in question or a devic e
for which equivalence to the device in question can be
demonstrated,
— clinically relevant information coming from post-market
surveillance, in particular the post-market clinical follow-up;
(49) ‘sponsor’ means any individual, company, institution or or ganis
ation which takes responsibility for the initiation, for the
management and setting up of the financing of the clinical
investigation;
(50) ‘subject’ means an individual who participates in a clinic al
investigation; ▼B | 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 by
the manufacturer;
(52) ‘clinical performance’ means the ability of a device, resu lting from
any direct or indirect medical effects which stem from its tech nical
or functional characteristics, including diagnostic characteris tics, to
achieve its intended purpose as claimed by the manufacturer,
thereby leading to a clinical benefit for patients, when used a s
intended by the manufacturer;
(53) ‘clinical benefit’ means the positive impact of a device o n the
health of an individual, expressed in terms of a meaningful,
measurable, patient-relevant clinical outcome(s), including
outcome(s) related to diagnosis, or a positive impact on patien t
management or public health;
(54) ‘investigator’ means an individual responsible for the con duct of a
clinical investigation at a clinical investigation site;
(55) ‘informed consent’ means a subject's free and voluntary ex pression
of his or her willingness to participate in a particular clinic al
investigation, after having been informed of all aspects of the
clinical investigation that are relevant to the subject's decis ion to
participate or, in the case of minors and of incapacitated subj ects,
an authorisation or agreement from their legally designated rep
resentative to include them in the clinical investigation;
(56) ‘ethics committee’ means an independent body established i n
a Member State in accordance with the law of that Member State
and empowered to give opinions for the purposes of this Regu
lation, taking into account the views of laypersons, in particu lar
patients or patients' organisations;
(57) ‘adverse event’ means any untoward medical occurrence, uni n
tended disease or injury or any untoward clinical signs,
including an abnormal laboratory finding, in subjects, users or
other persons, in the context of a clinical investigation, whet her
or not related to the investigational device;
(58) ‘serious adverse event’ means any adverse event that led t o any of
the following:
(a) death,
(b) serious deterioration in the health of the subject, that re sulted
in any of the following:
(i) life-threatening illness or injury,
(ii) permanent impairment of a body structure or a body
function,
(iii) hospitalisation or prolongation of patient hospitalisatio n,
(iv) medical or surgical intervention to prevent life-threateni ng
illness or injury or permanent impairment to a body
structure or a body function, ▼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, including malfunction, use errors or inadequacy in
information supplied by the manufacturer;
(60) ‘post-market surveillance’ means all activities carried ou t by manu
facturers in cooperation with other economic operators to insti tute
and keep up to date a systematic procedure to proactively colle ct
and review experience gained from devices they place on the
market, make available on the market or put into service for th e
purpose of identifying any need to immediately apply any
necessary corrective or preventive actions;
(61) ‘market surveillance’ means the activities carried out and measures
taken by competent authorities to check and ensure that devices
comply with the requirements set out in the relevant Union
harmonisation legislation and do not endanger health, safety or
any other aspect of public interest protection;
(62) ‘recall’ means any measure aimed at achieving the return o f a
device that has already been made available to the end user;
(63) ‘withdrawal’ means any measure aimed at preventing a devic e in
the supply chain from being further made available on the marke t;
(64) ‘incident’ means any malfunction or deterioration in the c haracte
ristics or performance of a device made available on the market ,
including use-error due to ergonomic features, as well as any
inadequacy in the information supplied by the manufacturer and
any undesirable side-effect;
(65) ‘serious incident’ means any incident that directly or ind irectly led,
might have led or might lead to any of the following:
(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patie nt's,
user's or other person's state of health,
(c) a serious public health threat;
(66) ‘serious public health threat’ means an event which could result in
imminent risk of death, serious deterioration in a person's sta te of
health, or serious illness, that may require prompt remedial ac tion,
and that may cause significant morbidity or mortality in humans ,
or that is unusual or unexpected for the given place and time;
(67) ‘corrective action’ means action taken to eliminate the ca use of a
potential or actual non-conformity or other undesirable situati on; ▼B | 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 communication sent by a manu
facturer to users or customers in relation to a field safety co rrective
action;
(70) ‘harmonised standard’ means a European standard as defined in
point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;
(71) ‘common specifications’ (CS) means a set of technical and/ or
clinical requirements, other than a standard, that provides a
means of complying with the legal obligations applicable to a
device, process or system.
Article 3
Amendment of certain definitions
The Commission is empowered to adopt delegated acts in accordan ce
with Article 115 in order to amend the definition of nanomateri al set out
in point (18) and the related definitions in points (19), (20) and (21) of
Article 2 in the light of technical and scientific progress and taking into
account definitions agreed at Union and international level.
Article 4
Regulatory status of products
1. Without prejudice to Article 2(2) of Directive 2001/83/EC, u pon a
duly substantiated request of a Member State, the Commission sh all,
after consulting the Medical Device Coordination Group establis hed
under Article 103 of this Regulation (‘MDCG’), by means of impl emen
ting acts, determine whether or not a specific product, or cate gory or
group of products, falls within the definitions of ‘medical dev ice’ or
‘accessory for a medical device’. Those implementing acts shall be
adopted in accordance with the examination procedure referred t o in
Article 114(3) of this Regulation.
2. The Commission may also, on its own initiative, after consul ting
the MDCG, decide, by means of implementing acts, on the issues
referred to in paragraph 1 of this Article. Those implementing acts
shall be adopted in accordance with the examination procedure
referred to in Article 114(3).
3. The Commission shall ensure that Member States share experti se
in the fields of medical devices, in vitro diagnostic medical devices,
medicinal products, human tissues and cells, cosmetics, biocide s, food
and, if necessary, other products, in order to determine the ap propriate
regulatory status of a product, or category or group of product s. ▼B | 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), the Europe an
Chemicals Agency (ECHA) and the European Food Safety
Authority (EFSA), as relevant.
CHAPTER II
MAKING AVAILABLE ON THE MARKET AND PUTTING INTO
SERVICE OF DEVICES, OBLIGATIONS OF ECONOMIC
OPERATORS, REPROCESSING, CE MARKING, FREE MOVEMENT
Article 5
Placing on the market and putting into service
1. A device may be placed on the market or put into service onl y if it
complies with this Regulation when duly supplied and properly
installed, maintained and used in accordance with its intended purpose.
2. A device shall meet the general safety and performance
requirements set out in Annex I which apply to it, taking into
account its intended purpose.
3. Demonstration of conformity with the general safety and
performance requirements shall include a clinical evaluation in
accordance with Article 61.
4. Devices that are manufactured and used within health institu tions
shall be considered as having been put into service.
5. With the exception of the relevant general safety and perfor mance
requirements set out in Annex I, the requirements of this Regul ation
shall not apply to devices, manufactured and used only within h ealth
institutions established in the Union, provided that all of the following
conditions are met:
(a) the devices are not transferred to another legal entity,
(b) manufacture and use of the devices occur under appropriate quality
management systems,
(c) the health institution justifies in its documentation that the target
patient group's specific needs cannot be met, or cannot be met at the
appropriate level of performance by an equivalent device availa ble
on the market,
(d) the health institution provides information upon request on the use
of such devices to its competent authority, which shall include a
justification of their manufacturing, modification and use;
(e) the health institution draws up a declaration which it shal l make
publicly available, including:
(i) the name and address of the manufacturing health institutio n; ▼B | 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 reasoned justification therefor,
(f) the health institution draws up documentation that makes it possible
to have an understanding of the manufacturing facility, the man u
facturing process, the design and performance data of the devic es,
including the intended purpose, and that is sufficiently detail ed to
enable the competent authority to ascertain that the general sa fety
and performance requirements set out in Annex I to this Regulat ion
are met;
(g) the health institution takes all necessary measures to ensu re that all
devices are manufactured in accordance with the documentation
referred to in point (f), and
(h) the health institution reviews experience gained from clini cal use of
the devices and takes all necessary corrective actions.
Member States may require that such health institutions submit to the
competent authority any further relevant information about such devices
which have been manufactured and used on their territory.
Member States shall retain the right to restrict the manufactur e and
the use of any specific type of such devices and shall be permi tted
access to inspect the activities of the health institutions.
This paragraph shall not apply to devices that are manufactured on an
industrial scale.
6. In order to ensure the uniform application of Annex I, the
Commission may adopt implementing acts to the extent necessary to
resolve issues of divergent interpretation and of practical app lication.
Those implementing acts shall be adopted in accordance with the exa
mination procedure referred to in Article 114(3).
Article 6
Distance sales
1. A device offered by means of information society services, a s
defined in point (b) of Article 1(1) of Directive (EU) 2015/153 5, to a
natural or legal person established in the Union shall comply w ith this
Regulation.
2. Without prejudice to national law regarding the exercise of the
medical profession, a device that is not placed on the market b ut used in
the context of a commercial activity, whether in return for pay ment or
free of charge, for the provision of a diagnostic or therapeuti c service
offered by means of information society services as defined in point (b)
of Article 1(1) of Directive (EU) 2015/1535 or by other means o f
communication, directly or through intermediaries, to a natural or
legal person established in the Union shall comply with this Re gulation. ▼B | 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 Member State may, on grounds of protection of public healt h,
require a provider of information society services, as defined in
point (b) of Article 1(1) of Directive (EU) 2015/1535, to cease its
activity.
Article 7
Claims
►C1 In the labelling, instructions for use, making available, putt ing
into service and advertising of devices, it shall be prohibited to use text,
names, trade marks, pictures and ◄ figurative or other signs th at may
mislead the user or the patient with regard to the device's int ended
purpose, safety and performance by:
(a) ascribing functions and properties to the device which the device
does not have;
(b) creating a false impression regarding treatment or diagnosi s,
functions or properties which the device does not have;
(c) failing to inform the user or the patient of a likely risk associated
with the use of the device in line with its intended purpose;
(d) suggesting uses for the device other than those stated to f orm part of
the intended purpose for which the conformity assessment was
carried out.
Article 8
Use of harmonised standards
1. Devices that are in conformity with the relevant harmonised
standards, or the relevant parts of those standards, the refere nces of
which have been published in the Official Journal of the European
Union , shall be presumed to be in conformity with the requirements
of this Regulation covered by those standards or parts thereof.
The first subparagraph shall also apply to system or process
requirements to be fulfilled in accordance with this Regulation by
economic operators or sponsors, including those relating to qua lity
management systems, risk management, post-market surveillance
systems, clinical investigations, clinical evaluation or post-m arket
clinical follow-up (‘PMCF’).
References in this Regulation to harmonised standards shall be
understood as meaning harmonised standards the references of wh ich
have been published in the Official Journal of the European Union . ▼B | 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 between
medicinal products and materials used in devices containing suc h
medicinal products, provided that references to those monograph s
have been published in the Official Journal of the European Union .
Article 9
Common specifications
1. Without prejudice to Article 1(2) and 17(5) and the deadline laid
down in those provisions, where no harmonised standards exist o r
where relevant harmonised standards are not sufficient, or wher e there
is a need to address public health concerns, the Commission, af ter
having consulted the MDCG, may, by means of implementing acts,
adopt common specifications (CS) in respect of the general safe ty and
performance requirements set out in Annex I, the technical docu men
tation set out in Annexes II and III, the clinical evaluation a nd
post-market clinical follow-up set out in Annex XIV or the requ irements
regarding clinical investigation set out in Annex XV. Those imp lemen
ting acts shall be adopted in accordance with the examination p rocedure
referred to in Article 114(3).
2. Devices that are in conformity with the CS referred to in
paragraph 1 shall be presumed to be in conformity with the
requirements of this Regulation covered by those CS or the rele vant
parts of those CS.
3. Manufacturers shall comply with the CS referred to in paragr aph 1
unless they can duly justify that they have adopted solutions t hat ensure
a level of safety and performance that is at least equivalent t hereto.
4. Notwithstanding paragraph 3, manufacturers of products liste d in
Annex XVI shall comply with the relevant CS for those products.
Article 10
General obligations of manufacturers
1. When placing their devices on the market or putting them int o
service, manufacturers shall ensure that they have been designe d and
manufactured in accordance with the requirements of this Regula tion.
2. Manufacturers shall establish, document, implement and maint ain
a system for risk management as described in Section 3 of Annex I .
3. Manufacturers shall conduct a clinical evaluation in accorda nce
with the requirements set out in Article 61 and Annex XIV, incl uding
a PMCF.
4. Manufacturers of devices other than custom-made devices shal l
draw up and keep up to date technical documentation for those
devices. The technical documentation shall be such as to allow the
conformity of the device with the requirements of this Regulati on to
be assessed. The technical documentation shall include the elem ents set
out in Annexes II and III. ▼B | 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 documentation in
accordance with Section 2 of Annex XIII.
6. Where compliance with the applicable requirements has been
demonstrated following the applicable conformity assessment pro cedure,
manufacturers of devices, other than custom-made or investigati onal
devices, shall draw up an EU declaration of conformity in accor dance
with Article 19, and affix the CE marking of conformity in acco rdance
with Article 20.
7. Manufacturers shall comply with the obligations relating to the
UDI system referred to in Article 27 and with the registration obli
gations referred to in Articles 29 and 31.
8. Manufacturers shall keep the technical documentation, the EU
declaration of conformity and, if applicable, a copy of any rel evant
certificate, including any amendments and supplements, issued i n
accordance with Article 56, available for the competent authori ties for
a period of at least 10 years after the last device covered by the
EU declaration of conformity has been placed on the market. In the
case of implantable devices, the period shall be at least 15 ye ars after
the last device has been placed on the market.
Upon request by a competent authority, the manufacturer shall, as
indicated therein, provide that technical documentation in its entirety
or a summary thereof.
A manufacturer with a registered place of business outside the Union
shall, in order to allow its authorised representative to fulfi l the tasks
mentioned in Article 11(3), ensure that the authorised represen tative has
the necessary documentation permanently available.
9. Manufacturers shall ensure that procedures are in place to k eep
series production in conformity with the requirements of this R egu
lation. Changes in device design or characteristics and changes in the
harmonised standards or CS by reference to which the conformity of a
device is declared shall be adequately taken into account in a timely
manner. Manufacturers of devices, other than investigational de vices,
shall establish, document, implement, maintain, keep up to date and
continually improve a quality management system that shall ensu re
compliance with this Regulation in the most effective manner an d in
a manner that is proportionate to the risk class and the type o f device.
The quality management system shall cover all parts and element s of a
manufacturer's organisation dealing with the quality of process es,
procedures and devices. It shall govern the structure, responsi bilities,
procedures, processes and management resources required to impl ement
the principles and actions necessary to achieve compliance with the
provisions of this Regulation.
The quality management system shall address at least the follow ing
aspects: ▼B | 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 exploration of options to address those
requirements;
(c) responsibility of the management;
(d) resource management, including selection and control of sup pliers
and sub-contractors;
(e) risk management as set out in in Section 3 of Annex I;
(f) clinical evaluation in accordance with Article 61 and Annex XIV,
including PMCF;
(g) product realisation, including planning, design, developmen t,
production and service provision;
(h) verification of the UDI assignments made in accordance with
Article 27(3) to all relevant devices and ensuring consistency and
validity of information provided in accordance with Article 29;
(i) setting-up, implementation and maintenance of a post-market
surveillance system, in accordance with Article 83;
(j) handling communication with competent authorities, notified
bodies, other economic operators, customers and/or other
stakeholders;
(k) processes for reporting of serious incidents and field safe ty
corrective actions in the context of vigilance;
(l) management of corrective and preventive actions and verific ation
of their effectiveness;
(m) processes for monitoring and measurement of output, data an alysis
and product improvement.
10. Manufacturers of devices shall implement and keep up to dat e
the post-market surveillance system in accordance with Article 83.
11. Manufacturers shall ensure that the device is accompanied b y the
information set out in Section 23 of Annex I in an official Uni on
language(s) determined by the Member State in which the device is
made available to the user or patient. The particulars on the l abel
shall be indelible, easily legible and clearly comprehensible t o the
intended user or patient.
12. Manufacturers who consider or have reason to believe that a
device which they have placed on the market or put into service is
not in conformity with this Regulation shall immediately take t he
necessary corrective action to bring that device into conformit y, to
withdraw it or to recall it, as appropriate. They shall inform the
distributors of the device in question and, where applicable, t he auth
orised representative and importers accordingly. ▼B | 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 Art icle 56, in
particular, of the non-compliance and of any corrective action taken.
13. Manufacturers shall have a system for recording and reporti ng of
incidents and field safety corrective actions as described in A rticles 87
and 88.
14. Manufacturers shall, upon request by a competent authority,
provide it with all the information and documentation necessary to
demonstrate the conformity of the device, in an official Union
language determined by the Member State concerned. The competen t
authority of the Member State in which the manufacturer has its
registered place of business may require that the manufacturer provide
samples of the device free of charge or, where that is impracti cable,
grant access to the device. Manufacturers shall cooperate with a
competent authority, at its request, on any corrective action t aken to
eliminate or, if that is not possible, mitigate the risks posed by devices
which they have placed on the market or put into service.
If the manufacturer fails to cooperate or the information and d ocumen
tation provided is incomplete or incorrect, the competent autho rity may,
in order to ensure the protection of public health and patient safety, take
all appropriate measures to prohibit or restrict the device's b eing made
available on its national market, to withdraw the device from t hat
market or to recall it until the manufacturer cooperates or pro vides
complete and correct information.
If a competent authority considers or has reason to believe tha t a device
has caused damage, it shall, upon request, facilitate the provi sion of the
information and documentation referred to in the first subparag raph to
the potentially injured patient or user and, as appropriate, th e patient's or
user's successor in title, the patient's or user's health insur ance company
or other third parties affected by the damage caused to the pat ient or
user, without prejudice to data protection rules and, unless th ere is an
overriding public interest in disclosure, without prejudice to the
protection of intellectual property rights.
The competent authority need not comply with the obligation lai d down
in the third subparagraph where disclosure of the information a nd docu
mentation referred to in the first subparagraph is ordinarily d ealt with in
the context of legal proceedings.
▼C1
15. Where manufacturers have their devices designed or manu
factured by another legal or natural person the information on the
identity of that person shall be part of the information to be
submitted in accordance with Article 29(4).
▼B
16. Natural or legal persons may claim compensation for damage
caused by a defective device in accordance with applicable Unio n and
national law. ▼B | 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... |
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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 prejudice to more protectiv e
measures under national law.
▼M5
Article 10a
Obligations in case of interruption or discontinuation of supply of
certain devices
1. Where a manufacturer anticipates an interruption or a discon
tinuation of the supply of a device, other than a custom-made d evice,
and where it is reasonably foreseeable that such interruption o r discon
tinuation could result in serious harm or a risk of serious har m to
patients or public health in one or more Member States, the man u
facturer shall inform the competent authority of the Member Sta te
where it or its authorised representative is established, as we ll as the
economic operators, health institutions and healthcare professi onals to
whom it directly supplies the device, of the anticipated interr uption or
discontinuation.
The information referred to in the first subparagraph shall, ot her than in
exceptional circumstances, be provided at least 6 months before the
anticipated interruption or discontinuation. The manufacturer s hall
specify the reasons for the interruption or discontinuation in the
information provided to the competent authority.
2. The competent authority that has received the information re ferred
to in paragraph 1 shall, without undue delay, inform the compet ent
authorities of the other Member States and the Commission of th e
anticipated interruption or discontinuation.
3. The economic operators who have received the information fro m
the manufacturer in accordance with paragraph 1 or from another
economic operator in the supply chain shall, without undue dela y,
inform any other economic operators, health institutions and he althcare
professionals to whom they directly supply the device, of the a nticipated
interruption or discontinuation.
▼B
Article 11
Authorised representative
1. Where the manufacturer of a device is not established in
a Member State, the device may only be placed on the Union mark et
if the manufacturer designates a sole authorised representative . ▼B | 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 representative shall perform the tasks specif ied in
the mandate agreed between it and the manufacturer. The authori sed
representative shall provide a copy of the mandate to the compe tent
authority, upon request.
The mandate shall require, and the manufacturer shall enable, t he auth
orised representative to perform at least the following tasks i n relation to
the devices that it covers:
(a) verify that the EU declaration of conformity and technical docu
mentation have been drawn up and, where applicable, that an app ro
priate conformity assessment procedure has been carried out by the
manufacturer;
(b) keep available a copy of the technical documentation, the E U
declaration of conformity and, if applicable, a copy of the
relevant certificate, including any amendments and supplements,
issued in accordance with Article 56, at the disposal of compet ent
authorities for the period referred to in Article 10(8);
(c) comply with the registration obligations laid down in Artic le 31 and
verify that the manufacturer has complied with the registration obli
gations laid down in Articles 27 and 29;
(d) in response to a request from a competent authority, provid e that
competent authority with all the information and documentation
necessary to demonstrate the conformity of a device, in an
official Union language determined by the Member State concerne d;
(e) forward to the manufacturer any request by a competent auth ority of
the Member State in which the authorised representative has its
registered place of business for samples, or access to a device
and verify that the competent authority receives the samples or is
given access to the device;
(f) cooperate with the competent authorities on any preventive or
corrective action taken to eliminate or, if that is not possibl e,
mitigate the risks posed by devices; ▼B | 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 obli
gations under this Regulation.
4. The mandate referred to in paragraph 3 of this Article shall not
delegate the manufacturer's obligations laid down in Article 10 (1), (2),
(3), (4), (6), (7), (9), (10), (11) and (12).
5. Without prejudice to paragraph 4 of this Article, where the manu
facturer is not established in a Member State and has not compl ied with
the obligations laid down in Article 10, the authorised represe ntative
shall be legally liable for defective devices on the same basis as, and
jointly and severally with, the manufacturer.
6. An authorised representative who terminates its mandate on t he
ground referred to in point (h) of paragraph 3 shall immediatel y inform
the competent authority of the Member State in which it is esta blished
and, where applicable, the notified body that was involved in t he
conformity assessment for the device of the termination of the
mandate and the reasons therefor.
7. Any reference in this Regulation to the competent authority of the
Member State in which the manufacturer has its registered place of
business shall be understood as a reference to the competent au thority
of the Member State in which the authorised representative, des ignated
by a manufacturer referred to in paragraph 1, has its registere d place of
business.
Article 12
Change of authorised representative
The detailed arrangements for a change of authorised representa tive
shall be clearly defined in an agreement between the manufactur er,
where practicable the outgoing authorised representative, and t he
incoming authorised representative. That agreement shall addres s at
least the following aspects:
(a) the date of termination of the mandate of the outgoing auth orised
representative and date of beginning of the mandate of the inco ming
authorised representative;
(b) the date until which the outgoing authorised representative may be
indicated in the information supplied by the manufacturer, incl uding
any promotional material;
(c) the transfer of documents, including confidentiality aspect s and
property rights;
(d) the obligation of the outgoing authorised representative af ter the end
of the mandate to forward to the manufacturer or incoming auth
orised representative any complaints or reports from healthcare
professionals, patients or users about suspected incidents rela ted to
a device for which it had been designated as authorised
representative. ▼B | 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 the EU declaration o f
conformity of the device has been drawn up;
(b) a manufacturer is identified and that an authorised represe ntative in
accordance with Article 11 has been designated by the
manufacturer;
(c) the device is labelled in accordance with this Regulation a nd accom
panied by the required instructions for use;
(d) where applicable, a UDI has been assigned by the manufactur er in
accordance with Article 27.
Where an importer considers or has reason to believe that a dev ice is
not in conformity with the requirements of this Regulation, it shall not
place the device on the market until it has been brought into c onformity
and shall inform the manufacturer and the manufacturer's author ised
representative. Where the importer considers or has reason to b elieve
that the device presents a serious risk or is a falsified devic e, it shall
also inform the competent authority of the Member State in whic h the
importer is established.
3. Importers shall indicate on the device or on its packaging o r in a
document accompanying the device their name, registered trade n ame or
registered trade mark, their registered place of business and t he address
at which they can be contacted, so that their location can be e stablished.
They shall ensure that any additional label does not obscure an y
information on the label provided by the manufacturer.
4. Importers shall verify that the device is registered in the electronic
system in accordance with Article 29. Importers shall add their details to
the registration in accordance with Article 31.
5. Importers shall ensure that, while a device is under their r espon
sibility, storage or transport conditions do not jeopardise its compliance
with the general safety and performance requirements set out in Annex I
and shall comply with the conditions set by the manufacturer, w here
available.
6. Importers shall keep a register of complaints, of non-confor ming
devices and of recalls and withdrawals, and provide the manufac turer,
authorised representative and distributors with any information
requested by them, in order to allow them to investigate compla ints. ▼B | 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 r, the
manufacturer's authorised representative and the competent auth orities
to ensure that the necessary corrective action to bring that de vice into
conformity, to withdraw or recall it is taken. Where the device presents
a serious risk, they shall also immediately inform the competen t auth
orities of the Member States in which they made the device avai lable
and, if applicable, the notified body that issued a certificate in
accordance with Article 56 for the device in question, giving d etails,
in particular, of the non-compliance and of any corrective acti on taken.
8. Importers who have received complaints or reports from healt hcare
professionals, patients or users about suspected incidents rela ted to a
device which they have placed on the market shall immediately f orward
this information to the manufacturer and its authorised represe ntative.
9. Importers shall, for the period referred to in Article 10(8) , keep a
copy of the EU declaration of conformity and, if applicable, a copy of
any relevant certificate, including any amendments and suppleme nts,
issued in accordance with Article 56.
10. Importers shall cooperate with competent authorities, at th e
latters' request, on any action taken to eliminate or, if that is not
possible, mitigate the risks posed by devices which they have p laced
on the market. Importers, upon request by a competent authority of the
Member State in which the importer has its registered place of business,
shall provide samples of the device free of charge or, where th at is
impracticable, grant access to the device.
Article 14
General obligations of distributors
1. When making a device available on the market, distributors s hall,
in the context of their activities, act with due care in relati on to the
requirements applicable.
2. Before making a device available on the market, distributors shall
verify that all of the following requirements are met:
(a) the device has been CE marked and that the EU declaration o f
conformity of the device has been drawn up;
(b) the device is accompanied by the information to be supplied by the
manufacturer in accordance with Article 10(11);
(c) for imported devices, the importer has complied with the
requirements set out in Article 13(3);
(d) that, where applicable, a UDI has been assigned by the
manufacturer.
In order to meet the requirements referred to in points (a), (b ) and (d) of
the first subparagraph the distributor may apply a sampling met hod that
is representative of the devices supplied by that distributor. ▼B | 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, where applic able,
the manufacturer's authorised representative, and the importer. Where
the distributor considers or has reason to believe that the dev ice presents
a serious risk or is a falsified device, it shall also inform t he competent
authority of the Member State in which it is established.
3. Distributors shall ensure that, while the device is under th eir
responsibility, storage or transport conditions comply with the
conditions set by the manufacturer.
4. Distributors that consider or have reason to believe that a device
which they have made available on the market is not in conformi ty with
this Regulation shall immediately inform the manufacturer and, where
applicable, the manufacturer's authorised representative and th e
importer. Distributors shall co-operate with the manufacturer a nd,
where applicable, the manufacturer's authorised representative, and the
importer, and with competent authorities to ensure that the nec essary
corrective action to bring that device into conformity, to with draw or to
recall it, as appropriate, is taken. Where the distributor cons iders or has
reason to believe that the device presents a serious risk, it s hall also
immediately inform the competent authorities of the Member Stat es in
which it made the device available, giving details, in particul ar, of the
non-compliance and of any corrective action taken.
5. Distributors that have received complaints or reports from
healthcare professionals, patients or users about suspected inc idents
related to a device they have made available, shall immediately
forward this information to the manufacturer and, where applica ble,
the manufacturer's authorised representative, and the importer. They
shall keep a register of complaints, of non-conforming devices and of
recalls and withdrawals, and keep the manufacturer and, where
available, the authorised representative and the importer infor med of
such monitoring and provide them with any information upon thei r
request.
6. Distributors shall, upon request by a competent authority, p rovide
it with all the information and documentation that is at their disposal
and is necessary to demonstrate the conformity of a device.
Distributors shall be considered to have fulfilled the obligati on referred
to in the first subparagraph when the manufacturer or, where ap plicable,
the authorised representative for the device in question provid es the
required information. Distributors shall cooperate with compete nt
authorities, at their request, on any action taken to eliminate the risks
posed by devices which they have made available on the market.
Distributors, upon request by a competent authority, shall prov ide free
samples of the device or, where that is impracticable, grant ac cess to the
device.
Article 15
Person responsible for regulatory compliance
1. Manufacturers shall have available within their organisation at
least one person responsible for regulatory compliance who poss esses
the requisite expertise in the field of medical devices. The re quisite
expertise shall be demonstrated by either of the following qual ifications: ▼B | 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
discipline, and at least one year of professional experience in regu
latory affairs or in quality management systems relating to med ical
devices;
(b) four years of professional experience in regulatory affairs or in
quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifi
cations, manufacturers of custom-made devices may demonstrate t he
requisite expertise referred to in the first subparagraph by ha ving at
least two years of professional experience within a relevant fi eld of
manufacturing.
2. Micro and small enterprises within the meaning of Commission
Recommendation 2003/361/EC ( 1 ) shall not be required to have the
person responsible for regulatory compliance within their organ isation
but shall have such person permanently and continuously at thei r
disposal.
3. The person responsible for regulatory compliance shall at le ast be
responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in
accordance with the quality management system under which the
devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of confo rmity
are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in
accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are
fulfilled;
(e) in the case of investigational devices, the statement refer red to in
Section 4.1 of Chapter II of Annex XV is issued.
4. If a number of persons are jointly responsible for regulator y
compliance in accordance with paragraphs 1, 2 and 3, their resp ective
areas of responsibility shall be stipulated in writing.
5. The person responsible for regulatory compliance shall suffe r no
disadvantage within the manufacturer's organisation in relation to the
proper fulfilment of his or her duties, regardless of whether o r not they
are employees of the organisation.
6. Authorised representatives shall have permanently and
continuously at their disposal at least one person responsible for regu
latory compliance who possesses the requisite expertise regardi ng the
regulatory requirements for medical devices in the Union. The r equisite
expertise shall be demonstrated by either of the following qual ifications: ▼B
( 1 ) Commission Recommendation 2003/361/ΕC of 6 May 2003 concernin g the
definition of micro, small and medium-sized enterprises (OJ L 1 24,
20.5.2003, p. 36). | 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
discipline, and at least one year of professional experience in regu
latory affairs or in quality management systems relating to med ical
devices;
(b) four years of professional experience in regulatory affairs or in
quality management systems relating to medical devices.
Article 16
Cases in which obligations of manufacturers apply to importers,
distributors or other persons
1. A distributor, importer or other natural or legal person sha ll
assume the obligations incumbent on manufacturers if it does an y of
the following:
(a) makes available on the market a device under its name, regi stered
trade name or registered trade mark, except in cases where a
distributor or importer enters into an agreement with a manufac turer
whereby the manufacturer is identified as such on the label and is
responsible for meeting the requirements placed on manufacturer s in
this Regulation;
(b) changes the intended purpose of a device already placed on the
market or put into service;
(c) modifies a device already placed on the market or put into service
in such a way that compliance with the applicable requirements may
be affected.
The first subparagraph shall not apply to any person who, while not
considered a manufacturer as defined in point (30) of Article 2 ,
assembles or adapts for an individual patient a device already on the
market without changing its intended purpose.
2. For the purposes of point (c) of paragraph 1, the following shall
not be considered to be a modification of a device that could a ffect its
compliance with the applicable requirements:
(a) provision, including translation, of the information suppli ed by the
manufacturer, in accordance with Section 23 of Annex I, relatin g to
a device already placed on the market and of further informatio n
which is necessary in order to market the device in the relevan t
Member State;
(b) changes to the outer packaging of a device already placed o n the
market, including a change of pack size, if the repackaging is
necessary in order to market the device in the relevant Member State
and if it is carried out in such conditions that the original c ondition
of the device cannot be affected by it. In the case of devices placed
on the market in sterile condition, it shall be presumed that t he
original condition of the device is adversely affected if the
packaging that is necessary for maintaining the sterile conditi on is
opened, damaged or otherwise negatively affected by the
repackaging. ▼B | 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 ther
with its name, registered trade name or registered trade mark, registered
place of business and the address at which it can be contacted, so that
its location can be established.
Distributors and importers shall ensure that they have in place a quality
management system that includes procedures which ensure that th e
translation of information is accurate and up-to-date, and that the
activities mentioned in points (a) and (b) of paragraph 2 are
performed by a means and under conditions that preserve the ori ginal
condition of the device and that the packaging of the repackage d device
is not defective, of poor quality or untidy. The quality manage ment
system shall cover, inter alia , procedures ensuring that the distributor
or importer is informed of any corrective action taken by the m anu
facturer in relation to the device in question in order to resp ond to safety
issues or to bring it into conformity with this Regulation.
4. At least 28 days prior to making the relabelled or repackage d
device available on the market, distributors or importers carry ing out
any of the activities mentioned in points (a) and (b) of paragr aph 2 shall
inform the manufacturer and the competent authority of the
Member State in which they plan to make the device available of the
intention to make the relabelled or repackaged device available and,
upon request, shall provide the manufacturer and the competent
authority with a sample or mock-up of the relabelled or repacka ged
device, including any translated label and instructions for use . Within
the same period of 28 days, the distributor or importer shall s ubmit to
the competent authority a certificate, issued by a notified bod y
designated for the type of devices that are subject to activiti es
mentioned in points (a) and (b) of paragraph 2, attesting that the
quality management system of the distributer or importer compli es
with the requirements laid down in paragraph 3.
Article 17
Single-use devices and their reprocessing
1. Reprocessing and further use of single-use devices may only take
place where permitted by national law and only in accordance wi th this
Article.
2. Any natural or legal person who reprocesses a single-use dev ice to
make it suitable for further use within the Union shall be cons idered to
be the manufacturer of the reprocessed device and shall assume the
obligations incumbent on manufacturers laid down in this Regula tion,
which include obligations relating to the traceability of the r eprocessed
device in accordance with Chapter III of this Regulation. The r epro
cessor of the device shall be considered to be a producer for t he purpose
of Article 3(1) of Directive 85/374/EEC. ▼B | 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
they ensure that:
(a) the safety and performance of the reprocessed device is equ ivalent
to that of the original device and the requirements in points ( a), (b),
(d), (e), (f), (g) and (h) of Article 5(5) are complied with;
(b) the reprocessing is performed in accordance with CS detaili ng the
requirements concerning:
— risk management, including the analysis of the construction a nd
material, related properties of the device (reverse engineering )
and procedures to detect changes in the design of the original
device as well as of its planned application after reprocessing ,
— the validation of procedures for the entire process, includin g
cleaning steps,
— the product release and performance testing,
— the quality management system,
— the reporting of incidents involving devices that have been
reprocessed, and
— the traceability of reprocessed devices.
Member States shall encourage, and may require, health institut ions to
provide information to patients on the use of reprocessed devic es within
the health institution and, where appropriate, any other releva nt
information on the reprocessed devices that patients are treate d with.
Member States shall notify the Commission and the other Member States
of the national provisions introduced pursuant to this paragrap h and the
grounds for introducing them. The Commission shall keep the
information publicly available.
4. Member States may choose to apply the provisions referred to in
paragraph 3 also as regards single-use devices that are reproce ssed by
an external reprocessor at the request of a health institution, provided
that the reprocessed device in its entirety is returned to that health
institution and the external reprocessor complies with the requ irements
referred to in points (a) and (b) of paragraph 3.
5. The Commission shall adopt, in accordance with Article 9(1), the
necessary CS referred to in point (b) of paragraph 3 by ►M1 26 May
2021 ◄. Those CS shall be consistent with the latest scientific evidence
and shall address the application of the general requirements o n safety
and performance laid down in in this Regulation. In the event t hat those
CS are not adopted by ►M1 26 May 2021 ◄, reprocessing shall be
performed in accordance with any relevant harmonised standards and
national provisions that cover the aspects outlined in point (b ) of
paragraph 3. Compliance with CS or, in the absence of CS, with any
relevant harmonised standards and national provisions, shall be certified
by a notified body. ▼B | 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 to the latest scientific evidence may be carried out.
8. The name and address of the legal or natural person referred to in
paragraph 2 and the other relevant information referred to in S ection 23
of Annex I shall be indicated on the label and, where applicabl e, in the
instructions for use of the reprocessed device.
The name and address of the manufacturer of the original single -use
device shall no longer appear on the label, but shall be mentio ned in the
instructions for use of the reprocessed device.
9. A Member State that permits reprocessing of single-use devic es
may maintain or introduce national provisions that are stricter than those
laid down in this Regulation and which restrict or prohibit, wi thin its
territory, the following:
(a) the reprocessing of single-use devices and the transfer of single-use
devices to another Member State or to a third country with a vi ew
to their reprocessing;
(b) the making available or further use of reprocessed single-u se
devices.
Member States shall notify the Commission and the other Member States
of those national provisions. The Commission shall make such
information publicly available.
10. The Commission shall by 27 May 2024 draw up a report on the
operation of this Article and submit it to the European Parliam ent and to
the Council. On the basis of that report, the Commission shall, if
appropriate, make proposals for amendments to this Regulation.
Article 18
Implant card and information to be supplied to the patient with an
implanted device
1. The manufacturer of an implantable device shall provide toge ther
with the device the following:
(a) information allowing the identification of the device, incl uding the
device name, serial number, lot number, the UDI, the device mod el,
as well as the name, address and the website of the manufacture r;
(b) any warnings, precautions or measures to be taken by the pa tient or
a healthcare professional with regard to reciprocal interferenc e with
reasonably foreseeable external influences, medical examination s or
environmental conditions;
(c) any information about the expected lifetime of the device a nd any
necessary follow-up; ▼B | 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 particular patien t who has
been implanted with the device, by any means that allow rapid a ccess to
that information and shall be stated in the language(s) determi ned by the
concerned Member State. The information shall be written in a w ay that
is readily understood by a lay person and shall be updated wher e
appropriate. Updates of the information shall be made available to the
patient via the website mentioned in point (a) of the first sub paragraph.
In addition, the manufacturer shall provide the information ref erred to in
point (a) of the first subparagraph on an implant card delivere d with the
device.
2. Member States shall require health institutions to make the
information referred to in paragraph 1 available, by any means that
allow rapid access to that information, to any patients who hav e been
implanted with the device, together with the implant card, whic h shall
bear their identity.
3. The following implants shall be exempted from the obligation s
laid down in this Article: sutures, staples, dental fillings, d ental
braces, tooth crowns, screws, wedges, plates, wires, pins, clip s and
connectors. The Commission is empowered to adopt delegated acts in
accordance with Article 115 to amend this list by adding other types of
implants to it or by removing implants therefrom.
Article 19
EU declaration of conformity
1. The EU declaration of conformity shall state that the requir ements
specified in this Regulation have been fulfilled in relation to the device
that is covered. The manufacturer shall continuously update the
EU declaration of conformity. The EU declaration of conformity
shall, as a minimum, contain the information set out in Annex I V
and shall be translated into an official Union language or lang uages
required by the Member State(s) in which the device is made ava ilable.
2. Where, concerning aspects not covered by this Regulation, de vices
are subject to other Union legislation which also requires an E U
declaration of conformity by the manufacturer that fulfilment o f the
requirements of that legislation has been demonstrated, a singl e
EU declaration of conformity shall be drawn up in respect of al l
Union acts applicable to the device. The declaration shall cont ain all
the information required for identification of the Union legisl ation to
which the declaration relates.
3. By drawing up the EU declaration of conformity, the manufact urer
shall assume responsibility for compliance with the requirement s of this
Regulation and all other Union legislation applicable to the de vice. ▼B | 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 than custom-made or investigational devices,
considered to be in conformity with the requirements of this Re gulation
shall bear the CE marking of conformity, as presented in Annex V.
2. The CE marking shall be subject to the general principles se t out
in Article 30 of Regulation (EC) No 765/2008.
3. The CE marking shall be affixed visibly, legibly and indelib ly to
the device or its sterile packaging. Where such affixing is not possible
or not warranted on account of the nature of the device, the CE marking
shall be affixed to the packaging. The CE marking shall also ap pear in
any instructions for use and on any sales packaging.
4. The CE marking shall be affixed before the device is placed on the
market. It may be followed by a pictogram or any other mark ind icating
a special risk or use.
5. Where applicable, the CE marking shall be followed by the id enti
fication number of the notified body responsible for the confor mity
assessment procedures set out in Article 52. The identification number
shall also be indicated in any promotional material which menti ons that
a device fulfils the requirements for CE marking.
6. Where devices are subject to other Union legislation which a lso
provides for the affixing of the CE marking, the CE marking sha ll
indicate that the devices also fulfil the requirements of that other
legislation.
Article 21
Devices for special purposes
1. Member States shall not create obstacles to:
(a) investigational devices being supplied to an investigator f or the
purpose of a clinical investigation if they meet the conditions laid
down in Articles 62 to 80 and Article 82, in the implementing a cts
adopted pursuant to Article 81 and in Annex XV;
(b) custom-made devices being made available on the market if
Article 52(8) and Annex XIII have been complied with.
The devices referred to in the first subparagraph shall not bea r the CE
marking, with the exception of the devices referred to in Artic le 74.
2. Custom-made devices shall be accompanied by the statement
referred to in Section 1 of Annex XIII, which shall be made ava ilable
to the particular patient or user identified by name, an acrony m or a
numerical code. ▼B | 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
... |
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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 not create obstacles to the showing of devi ces
which do not comply with this Regulation, provided a visible si gn
clearly indicates that such devices are intended for presentati on or
demonstration purposes only and cannot be made available until they
have been brought into compliance with this Regulation.
Article 22
Systems and procedure packs
1. Natural or legal persons shall draw up a statement if they c ombine
devices bearing a CE marking with the following other devices o r
products, in a manner that is compatible with the intended purp ose of
the devices or other products and within the limits of use spec ified by
their manufacturers, in order to place them on the market as a system or
procedure pack:
(a) other devices bearing the CE marking;
(b) in vitro diagnostic medical devices bearing the CE marking in
conformity with Regulation (EU) 2017/746;
(c) other products which are in conformity with legislation tha t applies
to those products only where they are used within a medical
procedure or their presence in the system or procedure pack is
otherwise justified.
2. In the statement made pursuant to paragraph 1, the natural o r legal
person concerned shall declare that:
(a) they verified the mutual compatibility of the devices and, if
applicable other products, in accordance with the manufacturers '
instructions and have carried out their activities in accordanc e
with those instructions;
(b) they packaged the system or procedure pack and supplied rel evant
information to users incorporating the information to be suppli ed by
the manufacturers of the devices or other products which have b een
put together;
(c) the activity of combining devices and, if applicable, other products
as a system or procedure pack was subject to appropriate method s
of internal monitoring, verification and validation.
3. Any natural or legal person who sterilises systems or proced ure
packs referred to in paragraph 1 for the purpose of placing the m on the
market shall, at their choice, apply one of the procedures set out in
Annex IX or the procedure set out in Part A of Annex XI. The ap pli
cation of those procedures and the involvement of the notified body ▼B | 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,
... |
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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 manufacturer's instruct ions.
4. Where the system or procedure pack incorporates devices whic h
do not bear the CE marking or where the chosen combination of d evices
is not compatible in view of their original intended purpose, o r where
the sterilisation has not been carried out in accordance with t he manu
facturer's instructions, the system or procedure pack shall be treated as a
device in its own right and shall be subject to the relevant co nformity
assessment procedure pursuant to Article 52. The natural or leg al person
shall assume the obligations incumbent on manufacturers.
5. The systems or procedure packs referred to in paragraph 1 of this
Article shall not themselves bear an additional CE marking but they
shall bear the name, registered trade name or registered trade mark of
the person referred to in paragraphs 1 and 3 of this Article as well as the
address at which that person can be contacted, so that the pers on's
location can be established. Systems or procedure packs shall b e accom
panied by the information referred to in Section 23 of Annex I. The
statement referred to in paragraph 2 of this Article shall be k ept at the
disposal of the competent authorities, after the system or proc edure pack
has been put together, for the period that is applicable under
Article 10(8) to the devices that have been combined. Where tho se
periods differ, the longest period shall apply.
Article 23
Parts and components
1. Any natural or legal person who makes available on the marke t an
item specifically intended to replace an identical or similar i ntegral part
or component of a device that is defective or worn in order to maintain
or restore the function of the device without changing its perf ormance
or safety characteristics or its intended purpose, shall ensure that the
item does not adversely affect the safety and performance of th e device.
Supporting evidence shall be kept available for the competent a uth
orities of the Member States.
2. An item that is intended specifically to replace a part or
component of a device and that significantly changes the perfor mance
or safety characteristics or the intended purpose of the device shall be
considered to be a device and shall meet the requirements laid down in
this Regulation.
Article 24
Free movement
Except where otherwise provided for in this Regulation, Member States
shall not refuse, prohibit or restrict the making available on the market
or putting into service within their territory of devices which comply
with the requirements of this Regulation. ▼B | 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 importers shall co-operate with manufacture rs or
authorised representatives to achieve an appropriate level of t raceability
of devices.
2. Economic operators shall be able to identify the following t o the
competent authority, for the period referred to in Article 10(8 ):
(a) any economic operator to whom they have directly supplied a
device;
(b) any economic operator who has directly supplied them with a
device;
(c) any health institution or healthcare professional to which they have
directly supplied a device.
Article 26
Medical devices nomenclature
To facilitate the functioning of the European database on medic al
devices (‘Eudamed’) as referred to in Article 33, the Commissio n
shall ensure that an internationally recognised medical devices nomen
clature is available free of charge to manufacturers and other natural or
legal persons required by this Regulation to use that nomenclat ure. The
Commission shall also endeavour to ensure that that nomenclatur e is
available to other stakeholders free of charge, where reasonabl y
practicable.
Article 27
Unique Device Identification system
1. The Unique Device Identification system (‘UDI system’) descr ibed
in Part C of Annex VI shall allow the identification and facili tate the
traceability of devices, other than custom-made and investigati onal
devices, and shall consist of the following:
(a) production of a UDI that comprises the following:
(i) a UDI device identifier (‘UDI-DI’) specific to a manufactur er
and a device, providing access to the information laid down in
Part B of Annex VI; ▼B | 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 economic operators, health institutio ns and
healthcare professionals, in accordance with the conditions lai d
down in paragraphs 8 and 9 of this Article respectively;
(d) establishment of an electronic system for Unique Device Ide ntifi
cation (‘UDI database’) in accordance with Article 28.
2. The Commission shall, by means of implementing acts, designa te
one or several entities to operate a system for assignment of U DIs
pursuant to this Regulation (‘issuing entity’). That entity or those
entities shall satisfy all of the following criteria:
(a) the entity is an organisation with legal personality;
(b) its system for the assignment of UDIs is adequate to identi fy a
device throughout its distribution and use in accordance with t he
requirements of this Regulation;
(c) its system for the assignment of UDIs conforms to the relev ant
international standards;
(d) the entity gives access to its system for the assignment of UDIs to
all interested users in accordance with a set of predetermined and
transparent terms and conditions;
(e) the entity undertakes to do the following:
(i) operate its system for the assignment of UDIs for at least 10
years after its designation;
(ii) make available to the Commission and to the Member States,
upon request, information concerning its system for the
assignment of UDIs;
(iii) remain in compliance with the criteria for designation an d the
terms of designation.
When designating issuing entities, the Commission shall endeavo ur to
ensure that UDI carriers, as defined in Part C of Annex VI, are
universally readable regardless of the system used by the issui ng
entity, with a view to minimising financial and administrative burdens
for economic operators and health institutions.
3. Before placing a device, other than a custom-made device, on the
market, the manufacturer shall assign to the device and, if app licable, to
all higher levels of packaging, a UDI created in compliance wit h the
rules of the issuing entity designated by the Commission in acc ordance
with paragraph 2.
Before a device, other than a custom-made or investigational de vice, is
placed on the market the manufacturer shall ensure that the inf ormation
referred to in Part B of Annex VI of the device in question are correctly
submitted and transferred to the UDI database referred to in Ar ticle 28. ▼B | 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 actions in accordance with Article 87.
6. The Basic UDI-DI, as defined in Part C of Annex VI, of the
device shall appear on the EU declaration of conformity referre d to in
Article 19.
7. As part of the technical documentation referred to in Annex II, the
manufacturer shall keep up-to-date a list of all UDIs that it h as assigned.
8. Economic operators shall store and keep, preferably by elect ronic
means, the UDI of the devices which they have supplied or with which
they have been supplied, if those devices belong to:
— class III implantable devices;
— the devices, categories or groups of devices determined by a
measure referred to in point (a) of paragraph 11.
9. Health institutions shall store and keep preferably by elect ronic
means the UDI of the devices which they have supplied or with
which they have been supplied, if those devices belong to class III
implantable devices.
For devices other than class III implantable devices, Member St ates
shall encourage, and may require, health institutions to store and
keep, preferably by electronic means, the UDI of the devices wi th
which they have been supplied.
Member States shall encourage, and may require, healthcare prof es
sionals to store and keep preferably by electronic means, the U DI of
the devices with which they have been supplied with.
10. The Commission is empowered to adopt delegated acts in
accordance with Article 115:
(a) amending the list of information set out in Part B of Annex VI in
the light of technical progress; and
(b) amending Annex VI in the light of international development s and
technical progress in the field of Unique Device Identification .
11. The Commission may, by means of implementing acts, specify
the detailed arrangements and the procedural aspects for the UD I system
with a view to ensuring its harmonised application in relation to any of
the following:
(a) determining the devices, categories or groups of devices to which
the obligation laid down in paragraph 8 is to apply;
(b) specifying the data to be included in the UDI-PI of specifi c devices
or device groups; ▼B | 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 following:
(a) confidentiality and data protection as referred to in Artic les 109 and
110 respectively;
(b) the risk-based approach;
(c) the cost-effectiveness of the measures;
(d) the convergence of UDI systems developed at international l evel;
(e) the need to avoid duplications in the UDI system;
(f) the needs of the healthcare systems of the Member States, a nd
where possible, compatibility with other medical device identif i
cation systems that are used by stakeholders.
Article 28
UDI database
1. The Commission, after consulting the MDCG shall set up and
manage a UDI database to validate, collate, process and make
available to the public the information mentioned in Part B of
Annex VI.
2. When designing the UDI database, the Commission shall take i nto
account the general principles set out in Section 5 of Part C o f
Annex VI. The UDI database shall be designed in particular such that
no UDI-PIs and no commercially confidential product information can
be included therein.
3. The core data elements to be provided to the UDI database,
referred to in Part B of Annex VI, shall be accessible to the p ublic
free of charge.
4. The technical design of the UDI database shall ensure maximu m
accessibility to information stored therein, including multi-us er access
and automatic uploads and downloads of that information. The
Commission shall provide for technical and administrative suppo rt to
manufacturers and other users of the UDI database.
Article 29
Registration of devices
1. Before placing a device, other than a custom-made device, on the
market, the manufacturer shall, in accordance with the rules of the
issuing entity referred to in Article 27(2), assign a Basic UDI -DI as
defined in Part C of Annex VI to the device and shall provide i t to the
UDI database together with the other core data elements referre d to in
Part B of Annex VI related to that device. ▼B | 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 Basic UDI-DI and
shall provide it to the UDI database together with the other co re data
elements referred to in Part B of Annex VI related to that syst em or
procedure pack.
3. For devices that are the subject of a conformity assessment as
referred to in Article 52(3) and in the second and third subpar agraphs of
Article 52(4), the assignment of a Basic UDI-DI referred to in
paragraph 1 of this Article shall be done before the manufactur er
applies to a notified body for that assessment.
For the devices referred to in the first subparagraph, the noti fied body
shall include a reference to the Basic UDI-DI on the certificat e issued in
accordance with point (a) of Section 4 of Chapter I of Annex XI I and
confirm in Eudamed that the information referred to in Section 2.2 of
Part A of Annex VI is correct. After the issuing of the relevan t certifi
cate and before placing the device on the market, the manufactu rer shall
provide the Basic UDI-DI to the UDI database together with the other
core data elements referred to in Part B of Annex VI related to that
device.
4. Before placing a device on the market, other than a custom-m ade
device, the manufacturer shall enter or if, already provided, v erify in
Eudamed the information referred to in Section 2 of Part A of
Annex VI, with the exception of Section 2.2 thereof, and shall thereafter
keep the information updated.
Article 30
Electronic system for registration of economic operators
1. The Commission, after consulting the MDCG, shall set up and
manage an electronic system to create the single registration n umber
referred to in Article 31(2) and to collate and process informa tion that is
necessary and proportionate to identify the manufacturer and, w here
applicable, the authorised representative and the importer. The details
regarding the information to be provided to that electronic sys tem by the
economic operators are laid down in Section 1 of Part A of Anne x VI.
2. Member States may maintain or introduce national provisions on
registration of distributors of devices which have been made av ailable
on their territory.
3. Within two weeks of placing a device, other than a custom-ma de
device, on the market, importers shall verify that the manufact urer or
authorised representative has provided to the electronic system the
information referred to in paragraph 1.
Where applicable, importers shall inform the relevant authorise d rep
resentative or manufacturer if the information referred to in p aragraph 1
is not included or is incorrect. Importers shall add their deta ils to the
relevant entry/entries. ▼B | 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 electronic system referred to in Article 30
the information referred to in Section 1 of Part A of Annex VI,
provided that they have not already registered in accordance wi th this
Article. In cases where the conformity assessment procedure req uires
the involvement of a notified body pursuant to Article 52, the
information referred to in Section 1 of Part A of Annex VI shal l be
provided to that electronic system before applying to the notif ied body.
2. After having verified the data entered pursuant to paragraph 1, the
competent authority shall obtain a single registration number ( ‘SRN’)
from the electronic system referred to in Article 30 and issue it to the
manufacturer, the authorised representative or the importer.
3. The manufacturer shall use the SRN when applying to a notifi ed
body for conformity assessment and for accessing Eudamed in ord er to
fulfil its obligations under Article 29.
4. Within one week of any change occurring in relation to the
information referred to in paragraph 1 of this Article, the eco nomic
operator shall update the data in the electronic system referre d to in
Article 30.
5. Not later than one year after submission of the information in
accordance with paragraph 1, and every second year thereafter, the
economic operator shall confirm the accuracy of the data. In th e
event of a failure to do so within six months of those deadline s, any
Member State may take appropriate corrective measures within it s
territory until that economic operator complies with that oblig ation.
6. Without prejudice to the economic operator's responsibility for the
data, the competent authority shall verify the confirmed data r eferred to
in Section 1 of Part A of Annex VI.
7. The data entered pursuant to paragraph 1 of this Article in the
electronic system referred to in Article 30 shall be accessible to the
public.
8. The competent authority may use the data to charge the manu
facturer, the authorised representative or the importer a fee p ursuant to
Article 111.
Article 32
Summary of safety and clinical performance
1. For implantable devices and for class III devices, other tha n
custom-made or investigational devices, the manufacturer shall draw
up a summary of safety and clinical performance. ▼B | 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
part of the documentation to be submitted to the notified body involved
in the conformity assessment pursuant to Article 52 and shall b e
validated by that body. After its validation, the notified body shall
upload the summary to Eudamed. The manufacturer shall mention o n
the label or instructions for use where the summary is availabl e.
2. The summary of safety and clinical performance shall include at
least the following aspects:
(a) the identification of the device and the manufacturer, incl uding the
Basic UDI-DI and, if already issued, the SRN;
(b) the intended purpose of the device and any indications, con traindi
cations and target populations;
(c) a description of the device, including a reference to previ ous
generation(s) or variants if such exist, and a description of t he
differences, as well as, where relevant, a description of any
accessories, other devices and products, which are intended to be
used in combination with the device;
(d) possible diagnostic or therapeutic alternatives;
(e) reference to any harmonised standards and CS applied;
(f) the summary of clinical evaluation as referred to in Annex XIV, and
relevant information on post-market clinical follow-up;
(g) suggested profile and training for users;
(h) information on any residual risks and any undesirable effec ts,
warnings and precautions.
3. The Commission may, by means of implementing acts, set out t he
form and the presentation of the data elements to be included i n the
summary of safety and clinical performance. Those implementing acts
shall be adopted in accordance with the advisory procedure refe rred to
in Article 114(2).
Article 33
European database on medical devices
1. The Commission, after consulting the MDCG, shall set up,
maintain and manage the European database on medical devices
(‘Eudamed’) for the following purposes:
(a) to enable the public to be adequately informed about device s placed
on the market, the corresponding certificates issued by notifie d
bodies and about the relevant economic operators; ▼B | 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 obligations under Articles 62 to 80, Article 82, and any a cts
adopted pursuant to Article 81;
(d) to enable manufacturers to comply with the information obli gations
laid down in Articles 87 to 90 or in any acts adopted pursuant to
Article 91;
(e) to enable the competent authorities of the Member States an d the
Commission to carry out their tasks relating to this Regulation on
a well-informed basis and to enhance the cooperation between th em.
2. Eudamed shall include the following electronic systems:
(a) the electronic system for registration of devices referred to in
Article 29(4);
(b) the UDI-database referred to in Article 28;
(c) the electronic system on registration of economic operators referred
to in Article 30;
(d) the electronic system on notified bodies and on certificate s referred
to in Article 57;
(e) the electronic system on clinical investigations referred t o in
Article 73;
(f) the electronic system on vigilance and post-market surveill ance
referred to in Article 92;
(g) the electronic system on market surveillance referred to in
Article 100.
3. When designing Eudamed the Commission shall give due con
sideration to compatibility with national databases and nationa l
web-interfaces to allow for import and export of data.
4. The data shall be entered into Eudamed by the Member States,
notified bodies, economic operators and sponsors as specified i n the
provisions on the electronic systems referred to in paragraph 2 . The
Commission shall provide for technical and administrative suppo rt to
users of Eudamed.
5. All the information collated and processed by Eudamed shall be
accessible to the Member States and to the Commission. The
information shall be accessible to notified bodies, economic op erators,
sponsors and the public to the extent specified in the provisio ns on the
electronic systems referred to in paragraph 2.
The Commission shall ensure that public parts of Eudamed are
presented in a user-friendly and easily-searchable format. ▼B | 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... |
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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 identification of da ta subjects
for periods no longer than those referred to in Article 10(8).
7. The Commission and the Member States shall ensure that data
subjects may effectively exercise their rights to information, of access,
to rectification and to object in accordance with Regu
lation (EC) No 45/2001 and Directive 95/46/EC, respectively. Th ey
shall also ensure that data subjects may effectively exercise t he right
of access to data relating to them, and the right to have inacc urate or
incomplete data corrected and erased. Within their respective r esponsi
bilities, the Commission and the Member States shall ensure tha t inac
curate and unlawfully processed data are deleted, in accordance with the
applicable legislation. Corrections and deletions shall be carr ied out as
soon as possible, but no later than 60 days after a request is made by a
data subject.
8. The Commission shall, by means of implementing acts, lay dow n
the detailed arrangements necessary for the setting up and main tenance
of Eudamed. Those implementing acts shall be adopted in accorda nce
with the examination procedure referred to in Article 114(3). W hen
adopting those implementing acts, the Commission shall ensure t hat,
as far as possible, the system is developed in such a way as to avoid
having to enter the same information twice within the same modu le or
in different modules of the system.
9. In relation to its responsibilities under this Article and t he
processing of personal data involved therein, the Commission sh all be
considered to be the controller of Eudamed and its electronic s ystems.
Article 34
Functionality of Eudamed
▼M5
1. The Commission shall, in collaboration with the MDCG, draw u p
the functional specifications for Eudamed. The Commission shall draw
up a plan for the implementation of those specifications by 26 May
2018.
2. The Commission shall inform the MDCG when, on the basis of
independent audit reports, it has verified that one or more of the elec
tronic systems referred to in Article 33(2) are functional and meet the
functional specifications drawn up pursuant to paragraph 1 of t his
Article.
▼B
3. The Commission shall, after consultation with the MDCG and
when it is satisfied that the conditions referred to in paragra ph 2 have
been fulfilled, publish a notice to that effect in the Official Journal of
the European Union . ▼B | 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... |
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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 this Regu
lation shall appoint an authority (‘authority responsible for n otified
bodies’), which may consist of separate constituent entities un der
national law and shall be responsible for setting up and carryi ng out
the necessary procedures for the assessment, designation and no tifi
cation of conformity assessment bodies and for the monitoring o f
notified bodies, including subcontractors and subsidiaries of t hose
bodies.
2. The authority responsible for notified bodies shall be estab lished,
organised and operated so as to safeguard the objectivity and i mpar
tiality of its activities and to avoid any conflicts of interes ts with
conformity assessment bodies.
3. The authority responsible for notified bodies shall be organ ised in
a manner such that each decision relating to designation or not ification
is taken by personnel different from those who carried out the
assessment.
4. The authority responsible for notified bodies shall not perf orm any
activities that notified bodies perform on a commercial or comp etitive
basis.
5. The authority responsible for notified bodies shall safeguar d the
confidential aspects of the information it obtains. However, it shall
exchange information on notified bodies with other Member State s,
the Commission and, when required, with other regulatory author ities.
6. The authority responsible for notified bodies shall have a s ufficient
number of competent personnel permanently available for the pro per
performance of its tasks.
Where the authority responsible for notified bodies is a differ ent
authority from the national competent authority for medical dev ices, it
shall ensure that the national authority responsible for medica l devices is
consulted on relevant matters.
7. Member States shall make publicly available general informat ion
on their measures governing the assessment, designation and not ification
of conformity assessment bodies and for the monitoring of notif ied
bodies, and on changes which have a significant impact on such tasks.
8. The authority responsible for notified bodies shall particip ate in
the peer-review activities provided for in Article 48. ▼B | 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... |
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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
process requirements that are necessary to fulfil those tasks. In
particular, notified bodies shall comply with Annex VII.
In order to meet the requirements referred to in the first subp aragraph,
notified bodies shall have permanent availability of sufficient adminis
trative, technical and scientific personnel in accordance with
Section 3.1.1 of Annex VII and personnel with relevant clinical
expertise in accordance with Section 3.2.4 of Annex VII, where
possible employed by the notified body itself.
The personnel referred to in Sections 3.2.3 and 3.2.7 of Annex VII shall
be employed by the notified body itself and shall not be extern al experts
or subcontractors.
2. Notified bodies shall make available and submit upon request all
relevant documentation, including the manufacturer's documentat ion, to
the authority responsible for notified bodies to allow it to co nduct its
assessment, designation, notification, monitoring and surveilla nce
activities and to facilitate the assessment outlined in this Ch apter.
3. In order to ensure the uniform application of the requiremen ts set
out in Annex VII, the Commission may adopt implementing acts, t o the
extent necessary to resolve issues of divergent interpretation and of
practical application. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Articl e 114(3).
Article 37
Subsidiaries and subcontracting
1. Where a notified body subcontracts specific tasks connected with
conformity assessment or has recourse to a subsidiary for speci fic tasks
connected with conformity assessment, it shall verify that the subcon
tractor or the subsidiary meets the applicable requirements set out in
Annex VII and shall inform the authority responsible for notifi ed bodies
accordingly.
2. Notified bodies shall take full responsibility for the tasks
performed on their behalf by subcontractors or subsidiaries.
3. Notified bodies shall make publicly available a list of thei r
subsidiaries.
4. Conformity assessment activities may be subcontracted or car ried
out by a subsidiary provided that the legal or natural person t hat applied
for conformity assessment has been informed accordingly. ▼B | 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... |
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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.
Article 38
Application by conformity assessment bodies for designation
1. Conformity assessment bodies shall submit an application for
designation to the authority responsible for notified bodies.
2. The application shall specify the conformity assessment acti vities
as defined in this Regulation, and the types of devices for whi ch the
body is applying to be designated, and shall be supported by do cumen
tation demonstrating compliance with Annex VII.
In respect of the organisational and general requirements and t he quality
management requirements set out in Sections 1 and 2 of Annex VI I, a
valid accreditation certificate and the corresponding evaluatio n report
delivered by a national accreditation body in accordance with R egu
lation (EC) No 765/2008 may be submitted and shall be taken int o
consideration during the assessment described in Article 39. Ho wever,
the applicant shall make available all the documentation referr ed to in
the first subparagraph to demonstrate compliance with those
requirements upon request.
3. The notified body shall update the documentation referred to in
paragraph 2 whenever relevant changes occur, in order to enable the
authority responsible for notified bodies to monitor and verify
continuous compliance with all the requirements set out in Anne x VII.
Article 39
Assessment of the application
1. The authority responsible for notified bodies shall within 3 0 days
check that the application referred to in Article 38 is complet e and shall
request the applicant to provide any missing information. Once the
application is complete that authority shall send it to the Com mission.
The authority responsible for notified bodies shall review the application
and supporting documentation in accordance with its own procedu res
and shall draw up a preliminary assessment report.
2. The authority responsible for notified bodies shall submit t he
preliminary assessment report to the Commission which shall imm edi
ately transmit it to the MDCG.
3. Within 14 days of the submission referred to in paragraph 2 of this
Article, the Commission, in conjunction with the MDCG, shall ap point
a joint assessment team made up of three experts, unless the sp ecific
circumstances require a different number of experts, chosen fro m the list
referred to in Article 40(2). One of the experts shall be a rep resentative
of the Commission who shall coordinate the activities of the jo int
assessment team. The other two experts shall come from Member S tates
other than the one in which the applicant conformity assessment body is
established. ▼B | 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... |
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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 Articl e 47(3),
to ensure that the specific concern can be appropriately assess ed.
4. Within 90 days of its appointment, the joint assessment team shall
review the documentation submitted with the application in acco rdance
with Article 38. The joint assessment team may provide feedback to, or
require clarification from, the authority responsible for notif ied bodies
on the application and on the planned on-site assessment.
The authority responsible for notified bodies together with the joint
assessment team shall plan and conduct an on-site assessment of the
applicant conformity assessment body and, where relevant, of an y
subsidiary or subcontractor, located inside or outside the Unio n, to be
involved in the conformity assessment process.
The on-site assessment of the applicant body shall be led by th e
authority responsible for notified bodies.
5. Findings regarding non-compliance of an applicant conformity
assessment body with the requirements set out in Annex VII shal l be
raised during the assessment process and discussed between the
authority responsible for notified bodies and the joint assessm ent team
with a view to reaching consensus and resolving any diverging
opinions, with respect to the assessment of the application.
At the end of the on-site assessment, the authority responsible for
notified bodies shall list for the applicant conformity assessm ent body
the non-compliances resulting from the assessment and summarise the
assessment by the joint assessment team.
Within a specified timeframe, the applicant conformity assessme nt body
shall submit to the national authority a corrective and prevent ive action
plan to address the non-compliances.
6. The joint assessment team shall document any remaining
diverging opinions with respect to the assessment within 30 day s of
completion of the on-site assessment and send them to the autho rity
responsible for notified bodies.
7. The authority responsible for notified bodies shall followin g
receipt of a corrective and preventive action plan from the app licant
body assess whether non-compliances identified during the asses sment
have been appropriately addressed. This plan shall indicate the root
cause of the identified non-compliances and shall include a tim eframe
for implementation of the actions therein.
The authority responsible for notified bodies shall having conf irmed the
corrective and preventive action plan forward it and its opinio n thereon
to the joint assessment team. The joint assessment team may req uest of
the authority responsible for notified bodies further clarifica tion and
modifications.
The authority responsible for notified bodies shall draw up its final
assessment report which shall include: ▼B | 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 scope of designation.
8. The authority responsible for notified bodies shall submit i ts final
assessment report and, if applicable, the draft designation to the
Commission, the MDCG and the joint assessment team.
9. The joint assessment team shall provide a final opinion rega rding
the assessment report prepared by the authority responsible for notified
bodies and, if applicable, the draft designation within 21 days of receipt
of those documents to the Commission, which shall immediately s ubmit
that final opinion to the MDCG. Within 42 days of receipt of th e
opinion of the joint assessment team, the MDCG shall issue a re com
mendation with regard to the draft designation, which the autho rity
responsible for notified bodies shall duly take into considerat ion for
its decision on the designation of the notified body.
10. The Commission may, by means of implementing acts, adopt
measures setting out the detailed arrangements specifying proce dures
and reports for the application for designation referred to in Article 38
and the assessment of the application set out in this Article. Those
implementing acts shall be adopted in accordance with the exami nation
procedure referred to in Article 114(3).
Article 40
Nomination of experts for joint assessment of applications for
notification
1. The Member States and the Commission shall nominate experts
qualified in the assessment of conformity assessment bodies in the field
of medical devices to participate in the activities referred to in
Articles 39 and 48.
2. The Commission shall maintain a list of the experts nominate d
pursuant to paragraph 1 of this Article, together with informat ion on
their specific field of competence and expertise. That list sha ll be made
available to Member States competent authorities through the el ectronic
system referred to in Article 57.
Article 41
Language requirements
All documents required pursuant to Articles 38 and 39 shall be drawn
up in a language or languages which shall be determined by the
Member State concerned.
Member States, in applying the first paragraph, shall consider accepting
and using a commonly understood language in the medical field, for all
or part of the documentation concerned. ▼B | 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, ... |
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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 with
Article 39(3).
Article 42
Designation and notification procedure
1. Member States may only designate conformity assessment bodie s
for which the assessment pursuant to Article 39 was completed a nd
which comply with Annex VII.
2. Member States shall notify the Commission and the other
Member States of the conformity assessment bodies they have
designated, using the electronic notification tool within the d atabase
of notified bodies developed and managed by the Commission
(NANDO).
3. The notification shall clearly specify, using the codes refe rred to in
paragraph 13 of this Article, the scope of the designation indi cating the
conformity assessment activities as defined in this Regulation and the
types of devices which the notified body is authorised to asses s and,
without prejudice to Article 44, any conditions associated with the
designation.
4. The notification shall be accompanied by the final assessmen t
report of the authority responsible for notified bodies, the fi nal
opinion of the joint assessment team referred to in Article 39( 9) and
the recommendation of the MDCG. Where the notifying Member Stat e
does not follow the recommendation of the MDCG, it shall provid e a
duly substantiated justification.
5. The notifying Member State shall, without prejudice to Artic le 44,
inform the Commission and the other Member States of any condit ions
associated with the designation and provide documentary evidenc e
regarding the arrangements in place to ensure that the notified body
will be monitored regularly and will continue to satisfy the re quirements
set out in Annex VII.
6. Within 28 days of the notification referred to in paragraph 2,
a Member State or the Commission may raise written objections,
setting out its arguments, with regard either to the notified b ody or to
its monitoring by the authority responsible for notified bodies . Where no
objection is raised, the Commission shall publish in NANDO the notifi
cation within 42 days of its having been notified as referred t o in
paragraph 2.
7. When a Member State or the Commission raises objections in
accordance with paragraph 6, the Commission shall bring the mat ter
before the MDCG within 10 days of the expiry of the period refe rred to
in paragraph 6. After consulting the parties involved, the MDCG shall
give its opinion at the latest within 40 days of the matter hav ing been
brought before it. Where the MDCG is of the opinion that the no tifi
cation can be accepted, the Commission shall publish in NANDO t he
notification within 14 days. ▼B | 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... |
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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
address the objections raised in the opinion, and set out the r easons
for the notifying Member State's decision to designate or not d esignate
the conformity assessment body.
9. Where the notifying Member State decides to uphold its decis ion
to designate the conformity assessment body, having given its r easons
in accordance with paragraph 8, the Commission shall publish in
NANDO the notification within 14 days of being informed thereof .
10. When publishing the notification in NANDO, the Commission
shall also add to the electronic system referred to in Article 57 the
information relating to the notification of the notified body a long with
the documents mentioned in paragraph 4 of this Article and the opinion
and responses referred to in paragraphs 7 and 8 of this Article .
11. The designation shall become valid the day after the notifi cation
is published in NANDO. The published notification shall state t he scope
of lawful conformity assessment activity of the notified body.
12. The conformity assessment body concerned may perform the
activities of a notified body only after the designation has be come
valid in accordance with paragraph 11.
13. The Commission shall by 26 November 2017, by means of im
plementing acts, draw up a list of codes and corresponding type s of
devices for the purpose of specifying the scope of the designat ion of
notified bodies. Those implementing acts shall be adopted in ac cordance
with the examination procedure referred to in Article 114(3). T he
Commission, after consulting the MDCG, may update this list bas ed,
inter alia , on information arising from the coordination activities
described in Article 48.
Article 43
Identification number and list of notified bodies
1. The Commission shall assign an identification number to each
notified body for which the notification becomes valid in accor dance
with Article 42(11). It shall assign a single identification nu mber even
when the body is notified under several Union acts. If they are
successfully designated in accordance with this Regulation, bod ies
notified pursuant to Directives 90/385/EEC and 93/42/EEC shall
retain the identification number assigned to them pursuant to t hose
Directives.
2. The Commission shall make the list of the bodies notified un der
this Regulation, including the identification numbers that have been
assigned to them and the conformity assessment activities as de fined
in this Regulation and the types of devices for which they have been
notified, accessible to the public in NANDO. It shall also make this list
available on the electronic system referred to in Article 57. T he
Commission shall ensure that the list is kept up to date. ▼B | 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.... |
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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 set
out in Annex VII or their ability to conduct the conformity ass essment
activities relating to the devices for which they have been des ignated.
2. The authorities responsible for notified bodies shall monito r the
notified bodies established on their territory and their subsid iaries and
subcontractors to ensure ongoing compliance with the requiremen ts and
the fulfilment of its obligations set out in this Regulation. N otified
bodies shall, upon request by their authority responsible for n otified
bodies, supply all relevant information and documents, required to
enable the authority, the Commission and other Member States to
verify compliance.
3. Where the Commission or the authority of a Member State
submits a request to a notified body established on the territo ry of
another Member State relating to a conformity assessment carrie d out
by that notified body, it shall send a copy of that request to the authority
responsible for notified bodies of that other Member State. The notified
body concerned shall respond without delay and within 15 days a t the
latest to the request. The authority responsible for notified b odies of the
Member State in which the body is established shall ensure that requests
submitted by authorities of any other Member State or by the
Commission are resolved by the notified body unless there is a
legitimate reason for not doing so in which case the matter may be
referred to the MDCG.
4. At least once a year, the authorities responsible for notifi ed bodies
shall re-assess whether the notified bodies established on thei r respective
territory and, where appropriate, the subsidiaries and subcontr actors
under the responsibility of those notified bodies still satisfy the
requirements and fulfil their obligations set out in Annex VII. That
review shall include an on-site audit of each notified body and , where
necessary, of its subsidiaries and subcontractors.
The authority responsible for notified bodies shall conduct its moni
toring and assessment activities according to an annual assessm ent
plan to ensure that it can effectively monitor the continued co mpliance
of the notified body with the requirements of this Regulation. That plan
shall provide a reasoned schedule for the frequency of assessme nt of the
notified body and, in particular, associated subsidiaries and s ubcon
tractors. The authority shall submit its annual plan for monito ring or
assessment for each notified body for which it is responsible t o the
MDCG and to the Commission.
5. The monitoring of notified bodies by the authority responsib le for
notified bodies shall include observed audits of notified body personnel,
including where necessary any personnel from subsidiaries and s ubcon
tractors, as that personnel is in the process of conducting qua lity
management system assessments at a manufacturer's facility. ▼B | 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 ... |
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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 shall provide for a
systematic follow-up of complaints and other information, inclu ding
from other Member States, which may indicate non-fulfilment of the
obligations by a notified body or its deviation from common or best
practice.
7. The authority responsible for notified bodies may in additio n to
regular monitoring or on-site assessments conduct short-notice, unan
nounced or ‘for-cause’ reviews if needed to address a particula r issue or
to verify compliance.
8. The authority responsible for notified bodies shall review t he
assessments by notified bodies of manufacturers' technical docu men
tation, in particular the clinical evaluation documentation as further
outlined in Article 45.
9. The authority responsible for notified bodies shall document and
record any findings regarding non-compliance of the notified bo dy with
the requirements set out in Annex VII and shall monitor the tim ely
implementation of corrective and preventive actions.
▼M2
10. 5 years after notification of a notified body, and again ev ery 5
years thereafter, a complete re-assessment to determine whether the
notified body still satisfies the requirements set out in Annex VII
shall be conducted by the authority responsible for notified bo dies of
the Member State in which the body is established and by a join t
assessment team in accordance with the procedure described in
Article 39.
The authority responsible for notified bodies of the Member Sta te in
which the notified body is established may conduct a complete
re-assessment prior to the dates referred to in the first subpa ragraph,
upon request by the notified body or where, based on the result s of the
annual assessments conducted in accordance with paragraph 4 of this
Article, it has concerns regarding the continued fulfilment by the
notified body of the requirements set out in Annex VII.
Complete re-assessments that have already started prior to 11 M arch
2023 shall continue to be conducted, unless the authority respo nsible for
notified bodies of the Member State in which the notified body is
established decides to suspend or terminate the ongoing complet e
re-assessment, taking into account its own resources and the re sources
of the notified body already spent on the re-assessment, as wel l as the
results of the annual assessments conducted in accordance with
paragraph 4 of this Article. Before suspending or terminating a n
ongoing complete re-assessment, the authority responsible for n otified
bodies shall hear the notified body concerned. ▼B | 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 the Commission and to the
MDCG, at least once a year, on their monitoring and on-site ass essment
activities regarding notified bodies and, where applicable, sub sidiaries
and subcontractors. The report shall provide details of the out come of
those activities, including activities pursuant to paragraph 7, and shall
be treated as confidential by the MDCG and the Commission; howe ver
it shall contain a summary which shall be made publicly availab le.
The summary of the report shall be uploaded to the electronic s ystem
referred to in Article 57.
Article 45
Review of notified body assessment of technical documentation and
clinical evaluation documentation
1. The authority responsible for notified bodies, as part of it s ongoing
monitoring of notified bodies, shall review an appropriate numb er of
notified body assessments of manufacturers' technical documenta tion, in
particular the clinical evaluation documentation as referred to in points
(c) and (d) of Section 6.1 of Annex II to verify the conclusion s drawn
by the notified body based on the information presented by the manu
facturer. The reviews by the authority responsible for notified bodies
shall be conducted both off-site and on-site.
2. The sampling of files to be reviewed in accordance with
paragraph 1 shall be planned and representative of the types an d risk
of devices certified by the notified body, in particular high-r isk devices,
and be appropriately justified and documented in a sampling pla n,
which shall be made available by the authority responsible for
notified bodies to the MDCG upon request.
3. The authority responsible for notified bodies shall review w hether
the assessment by the notified body was conducted appropriately and
shall check the procedures used, associated documentation and t he
conclusions drawn by the notified body. Such checking shall inc lude
the technical documentation and clinical evaluation documentati on of
the manufacturer upon which the notified body has based its
assessment. Such reviews shall be conducted utilising CS.
4. Those reviews shall also form part of the re-assessment of n otified
bodies in accordance with Article 44(10) and the joint assessme nt
activities referred to in Article 47(3). The reviews shall be c onducted
utilising appropriate expertise. ▼B | 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... |
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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
toring of technical progress, or on the identification of conce rns and
emerging issues concerning the safety and performance of device s, the
MDCG may recommend that the sampling, carried out under this
Article, cover a greater or lesser proportion of the technical documen
tation and clinical evaluation documentation assessed by a noti fied
body.
6. The Commission may, by means of implementing acts, adopt
measures setting out the detailed arrangements, associated docu ments
for, and coordination of, the review of assessments of technica l docu
mentation and clinical evaluation documentation, as referred to in this
Article. Those implementing acts shall be adopted in accordance with
the examination procedure referred to in Article 114(3).
Article 46
Changes to designations and notifications
1. The authority responsible for notified bodies shall notify t he
Commission and the other Member States of any relevant changes to
the designation of a notified body.
The procedures described in Article 39 and in Article 42 shall apply to
extensions of the scope of the designation.
For changes to the designation other than extensions of its sco pe, the
procedures laid down in the following paragraphs shall apply.
2. The Commission shall immediately publish the amended notifi
cation in NANDO. The Commission shall immediately enter
information on the changes to the designation of the notified b ody in
the electronic system referred to in Article 57.
3. Where a notified body decides to cease its conformity assess ment
activities it shall inform the authority responsible for notifi ed bodies and
the manufacturers concerned as soon as possible and in the case of a
planned cessation one year before ceasing its activities. The c ertificates
may remain valid for a temporary period of nine months after ce ssation
of the notified body's activities on condition that another not ified body
has confirmed in writing that it will assume responsibilities f or the
devices covered by those certificates. The new notified body sh all
complete a full assessment of the devices affected by the end o f that
period before issuing new certificates for those devices. Where the
notified body has ceased its activity, the authority responsibl e for
notified bodies shall withdraw the designation.
4. Where a authority responsible for notified bodies has ascert ained
that a notified body no longer meets the requirements set out i n
Annex VII, or that it is failing to fulfil its obligations or h as not im
plemented the necessary corrective measures, the authority shal l
suspend, restrict, or fully or partially withdraw the designati on,
depending on the seriousness of the failure to meet those requi rements
or fulfil those obligations. A suspension shall not exceed a pe riod of
one year, renewable once for the same period. ▼B | 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, the notified body shall inform the manufac turers
concerned at the latest within 10 days.
6. In the event of restriction, suspension or withdrawal of a d esig
nation, the authority responsible for notified bodies shall tak e appro
priate steps to ensure that the files of the notified body conc erned are
kept and make them available to authorities in other Member Sta tes
responsible for notified bodies and to authorities responsible for
market surveillance at their request.
7. In the event of restriction, suspension or withdrawal of a d esig
nation, the authority responsible for notified bodies shall:
(a) assess the impact on the certificates issued by the notifie d body;
(b) submit a report on its findings to the Commission and the o ther
Member States within three months of having notified the change s
to the designation;
(c) require the notified body to suspend or withdraw, within a
reasonable period of time determined by the authority, any
certificates which were unduly issued to ensure the safety of
devices on the market;
(d) enter into the electronic system referred to in Article 57 information
in relation to certificates of which it has required their susp ension or
withdrawal;
(e) inform the competent authority for medical devices of the
Member State in which the manufacturer has its registered place
of business through the electronic system referred to in Articl e 57 of
the certificates for which it has required suspension or withdr awal.
That competent authority shall take the appropriate measures, w here
necessary to avoid a potential risk to the health or safety of patients,
users or others.
8. With the exception of certificates unduly issued, and where a
designation has been suspended or restricted, the certificates shall
remain valid in the following circumstances:
(a) the authority responsible for notified bodies has confirmed , within
one month of the suspension or restriction, that there is no sa fety
issue in relation to certificates affected by the suspension or
restriction, and the authority responsible for notified bodies has
outlined a timeline and actions anticipated to remedy the suspe nsion
or restriction; or ▼B | 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 ng
to monitor and remain responsible for existing certificates iss ued
for the period of the suspension or restriction. In the event t hat
the authority responsible for notified bodies determines that t he
notified body does not have the capability to support existing
certificates issued, the manufacturer shall provide, to the
competent authority for medical devices of the Member State in
which the manufacturer of the device covered by the certificate
has its registered place of business, within three months of th e
suspension or restriction, a written confirmation that another
qualified notified body is temporarily assuming the functions o f
the notified body to monitor and remain responsible for the
certificates during the period of suspension or restriction.
9. With the exception of certificates unduly issued, and where a
designation has been withdrawn, the certificates shall remain v alid for
a period of nine months in the following circumstances:
(a) where the competent authority for medical devices of the
Member State in which the manufacturer of the device covered
by the certificate has its registered place of business has
confirmed that there is no safety issue associated with the dev ices
in question; and
(b) another notified body has confirmed in writing that it will assume
immediate responsibilities for those devices and will have
completed assessment of them within twelve months of the with
drawal of the designation.
In the circumstances referred to in the first subparagraph, the competent
authority for medical devices of the Member State in which the manu
facturer of the device covered by the certificate has its place of business
may extend the provisional validity of the certificates for fur ther periods
of three months, which altogether shall not exceed twelve month s.
The authority or the notified body assuming the functions of th e notified
body affected by the change of designation shall immediately in form the
Commission, the other Member States and the other notified bodi es
thereof.
Article 47
Challenge to the competence of notified bodies
1. The Commission, in conjunction with the MDCG, shall investig ate
all cases where concerns have been brought to its attention reg arding the
continued fulfilment by a notified body, or of one or more of i ts
subsidiaries or subcontractors, of the requirements set out in
Annex VII or the obligations to which they are subject. It shal l
ensure that the relevant authority responsible for notified bod ies is
informed and is given an opportunity to investigate those conce rns.
2. The notifying Member State shall provide the Commission, on
request, with all information regarding the designation of the notified
body concerned. ▼B | 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 body with
the requirements set out in Annex VII and where the investigati on by
the authority responsible for notified bodies is not deemed to have fully
addressed the concerns or upon request of the authority respons ible for
notified bodies. The reporting and outcome of that assessment s hall
follow the principles of Article 39. Alternatively, depending o n the
severity of the issue, the Commission, in conjunction with the
MDCG, may request that the authority responsible for notified b odies
allow the participation of up to two experts from the list esta blished
pursuant to Article 40 in an on-site assessment as part of the planned
monitoring and assessment activities in accordance with Article 44 and
as outlined in the annual assessment plan described in Article 44(4).
4. Where the Commission ascertains that a notified body no long er
meets the requirements for its designation, it shall inform the notifying
Member State accordingly and request it to take the necessary c orrective
measures, including the suspension, restriction or withdrawal o f the
designation if necessary.
Where the Member State fails to take the necessary corrective m easures,
the Commission may, by means of implementing acts, suspend, res trict
or withdraw the designation. Those implementing acts shall be a dopted
in accordance with the examination procedure referred to in
Article 114(3). It shall notify the Member State concerned of i ts
decision and update NANDO and the electronic system referred to in
Article 57.
5. The Commission shall ensure that all confidential informatio n
obtained in the course of its investigations is treated accordi ngly.
Article 48
Peer review and exchange of experience between authorities
responsible for notified bodies
1. The Commission shall provide for the organisation of exchang e of
experience and coordination of administrative practice between the auth
orities responsible for notified bodies. Such exchange shall co ver
elements including:
(a) development of best practice documents relating to the acti vities of
the authorities responsible for notified bodies;
(b) development of guidance documents for notified bodies in re lation
to the implementation of this Regulation;
(c) training and qualification of the experts referred to in Ar ticle 40;
(d) monitoring of trends relating to changes to notified body d esig
nations and notifications and trends in certificate withdrawals and
transfers between notified bodies; ▼B | 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 activities of authorities and the Commission on
notified bodies.
2. The authorities responsible for notified bodies shall partic ipate in a
peer review every third year through the mechanism developed pu rsuant
to paragraph 1 of this Article. Such reviews shall normally be conducted
in parallel with the on-site joint assessments described in Art icle 39.
Alternatively, an authority may make the choice of having such reviews
take place as part of its monitoring activities referred to in Article 44.
3. The Commission shall participate in the organisation and pro vide
support to the implementation of the peer review mechanism.
4. The Commission shall compile an annual summary report of the
peer review activities, which shall be made publicly available.
5. The Commission may, by means of implementing acts, adopt
measures setting out the detailed arrangements and related docu ments
for the peer review mechanism and training and qualification as referred
to in paragraph 1 of this Article. Those implementing acts shal l be
adopted in accordance with the examination procedure referred t o in
Article 114(3).
Article 49
Coordination of notified bodies
The Commission shall ensure that appropriate coordination and c ooper
ation between notified bodies is put in place and operated in t he form of
a coordination group of notified bodies in the field of medical devices,
including in vitro diagnostic medical devices. This group shall meet on
a regular basis and at least annually.
The bodies notified under this Regulation shall participate in the work
of that group.
The Commission may establish the specific arrangements for the func
tioning of the coordination group of notified bodies. ▼B | 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 1
Classification
Article 51
Classification of devices
1. Devices shall be divided into classes I, IIa, IIb and III, t aking into
account the intended purpose of the devices and their inherent risks.
Classification shall be carried out in accordance with Annex VI II.
2. Any dispute between the manufacturer and the notified body
concerned, arising from the application of Annex VIII, shall be
referred for a decision to the competent authority of the Membe r State
in which the manufacturer has its registered place of business. In cases
where the manufacturer has no registered place of business in t he Union
and has not yet designated an authorised representative, the ma tter shall
be referred to the competent authority of the Member State in w hich the
authorised representative referred to in the last indent of poi nt (b) of
the second paragraph of Section 2.2 of Annex IX has its registe red
place of business. Where the notified body concerned is establi shed
in a Member State other than that of the manufacturer, the comp etent
authority shall adopt its decision after consultation with the competent
authority of the Member State that designated the notified body .
The competent authority of the Member State in which the manufa cturer
has its registered place of business shall notify the MDCG and the
Commission of its decision. The decision shall be made availabl e
upon request.
3. At the request of a Member State the Commission shall after
consulting the MDCG, decide, by means of implementing acts, on the
following:
(a) application of Annex VIII to a given device, or category or group of
devices, with a view to determining the classification of such
devices;
(b) that a device, or category or group of devices, shall for r easons of
public health based on new scientific evidence, or based on any
information which becomes available in the course of the vigila nce
and market surveillance activities be reclassified, by way of d ero
gation from Annex VIII.
4. The Commission may also, on its own initiative and after
consulting the MDCG, decide, by means of implementing acts, on the
issues referred to in points (a) and (b) of paragraph 3. ▼B | 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
and of practical application.
6. The implementing acts referred to in paragraphs 3, 4 and 5 o f this
Article shall be adopted in accordance with the examination pro cedure
referred to in Article 114(3).
SECTION 2
Conformity assessment
Article 52
Conformity assessment procedures
1. Prior to placing a device on the market, manufacturers shall
undertake an assessment of the conformity of that device, in ac cordance
with the applicable conformity assessment procedures set out in
Annexes IX to XI.
2. Prior to putting into service a device that is not placed on the
market, manufacturers shall undertake an assessment of the conf ormity
of that device, in accordance with the applicable conformity as sessment
procedures set out in Annexes IX to XI.
3. Manufacturers of class III devices, other than custom-made o r
investigational devices, shall be subject to a conformity asses sment as
specified in Annex IX. Alternatively, the manufacturer may choo se to
apply a conformity assessment as specified in Annex X coupled w ith a
conformity assessment as specified in Annex XI.
4. Manufacturers of class IIb devices, other than custom-made o r
investigational devices, shall be subject to a conformity asses sment as
specified in Chapters I and III of Annex IX, and including an
assessment of the technical documentation as specified in Secti on 4
of that Annex of at least one representative device per generic device
group.
However, for class IIb implantable devices, except sutures, sta ples,
dental fillings, dental braces, tooth crowns, screws, wedges, p lates,
wires, pins, clips and connectors, the assessment of the techni cal docu
mentation as specified in Section 4 of Annex IX shall apply for every
device.
Alternatively, the manufacturer may choose to apply a conformit y
assessment based on type examination as specified in Annex X
coupled with a conformity assessment based on product conformit y
verification as specified in Annex XI. ▼B | 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... |
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