Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
Date: 2012-09-26
Institutions: European Commission
Subjects: marketing standard, medical device, medical diagnosis, quality standard, safety standard

EUROPEAN COMMISSION 

Brussels, 26.9.2012  
COM(2012) 542 final 

2012/0266 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 
and Regulation (EC) No 1223/2009 

(Text with EEA relevance) 

{SWD(2012) 273 final} 
{SWD(2012) 274 final}

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The  current  EU  regulatory  framework  for  medical  devices,  other  than  in  vitro  diagnostic 
medical  devices,  consists  of  Council  Directive  90/385/EEC  on  active  implantable  medical 
devices  (AIMDD)1  and  Council  Directive  93/42/EEC  on  medical  devices  (MDD)2  which 
cover a huge spectrum of products. The MDD divides them into four classes of risk: class I 
(low risk, e.g. sticking plasters, corrective glasses), class IIa (medium-low risk, e.g. tracheal 
tubes, dental filling material), class IIb (medium-high risk, e.g. X-ray machines, bone plates 
and screws) and class III (high risk, e.g. heart valves, total hip replacements, breast implants). 
Active implantable medical devices (e.g. pacemakers, implantable defibrillators) covered by 
the AIMDD fall de facto into class III.  

The two Directives, adopted in the 1990s, are based on the ‘New Approach’ and aim to ensure 
the smooth functioning of the internal market and a high level of protection of human health 
and  safety.  Medical  devices  are  not  subject  to  any  pre-market  authorisation  by  a  regulatory 
authority but to a conformity assessment which, for medium and high risk devices, involves 
an  independent  third  party,  known  as  ‘notified  body’.  Notified  bodies,  of  which  there  are 
around 80 across Europe, are designated and monitored by the Member States and act under 
the  control  of  the  national  authorities.  Once  certified,  devices  bear  the  CE  marking  which 
allows them to circulate freely in the EU/EFTA countries and Turkey. 

The existing regulatory framework has demonstrated its merits but has also come under harsh 
criticism,  in  particular  after  the  French  health  authorities  found  that  a  French  manufacturer 
(Poly Implant Prothèse, PIP) had for several years apparently used industrial silicone instead 
of  medical  grade  silicone  for  the  manufacture  of  breast  implants  contrary  to  the  approval 
issued by the notified body, causing harm to thousands of women around the world.  

In  an  internal  market  with  32  participating  countries3  and  subject  to  constant  technological 
and  scientific  progress,  substantial  divergences  in  the  interpretation  and  application  of  the 
rules have emerged, thus undermining the main objectives of the Directives, i.e. the safety of 
medical  devices  and  their  free  movement  within  the  internal  market.  Moreover,  regulatory 
gaps  or  uncertainties  exist  with  regard  to  certain  products  (e.g.  products  manufactured 
utilising  non-viable  human  tissues  or  cells;  implantable  or  other  invasive  products  for 
cosmetic purposes).  

This revision aims to overcome these flaws and gaps and to further strengthen patient safety. 
A robust, transparent and sustainable regulatory framework should be put in place that is ‘fit 
for purpose’. This framework should be supportive of innovation and the competitiveness of 
the  medical  device  industry  and  should  allow  rapid  and  cost-efficient  market  access  for 
innovative medical devices, to the benefit of patients and healthcare professionals. 

This proposal is adopted alongside a proposal for a Regulation on in vitro diagnostic medical 
devices  (IVDs),  such  as  blood  tests,  which  are  covered  by  Directive  98/79/EC  of  the 

1 
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3 

OJ L 189, 20.7.1990, p. 17. 
OJ L 169, 12.7.1993, p. 1. 
EU Member States, EFTA countries and Turkey.  

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European Parliament and of the Council (IVDD)4. The horizontal aspects that are common to 
both sectors are aligned whilst the specific features of each sector require separate legal acts.  

2. 

RESULTS  OF  CONSULTATIONS  WITH  INTERESTED  PARTIES  AND 
IMPACT ASSESSMENTS 

In preparation for the impact assessment on this proposal and the proposal for a Regulation on 
IVDs, the Commission held two public consultations, the first from 8 May to 2 July 2008, and 
the  second  from  29  June  to  15  September  2010.  In  both  public  consultations,  the  general 
principles  and  minimum  standards  for  consultation  of  interested  parties  by  the  Commission 
were  applied;  responses  received  within  a  reasonable  period  after  the  deadlines  were  taken 
into  account.  After  analysing  all  the  responses,  the  Commission  published  a  summary 
outcome and the individual responses on its website5. 

The majority of respondents to the 2008 public consultation (in particular Member States and 
industry)  considered  the  proposed  revision  to  be  premature.  They  pointed  to  Directive 
2007/47/EC of the European Parliament and of the Council6, which amended the AIMDD and 
the  MDD  and  was  to  be  implemented  by  21  March  2010,  and  also  to  the  New  Legislative 
Framework for the Marketing of Products which was due to enter into force with effect from 
1  January  2010,  and  argued  that  it  would  be  advisable  to  wait  for  these  changes  to  be 
implemented, in order to assess the need for further adjustments better.  

The  2010  public  consultation  focussed  on  aspects  related  to  the  revision  of  the  IVDD  and 
showed wide support for this initiative, linked to the revision of the regulatory framework for 
medical devices in general.  

During  2009,  2010  and  2011,  the  issues  to  be  tackled  in  the  revision  of  the  regulatory 
framework for medical devices were regularly discussed at meetings of the Medical Devices 
Expert  Group  (MDEG),  the  Competent  Authorities  for  Medical  Devices  (CAMD)  and 
specific working groups in the fields of notified bodies, borderline and classification, clinical 
investigation  and  evaluation,  vigilance,  market  surveillance,  in  vitro  diagnostics  medical 
devices  (IVD)  and  in  an  ad  hoc  working  group  on  Unique  Device  Identification  (UDI).  A 
special  meeting  of  the  MDEG  was  held  on  31  March  and  1  April  2011  to  discuss  issues 
related to the impact assessment. Moreover, the Heads of Medicines Agencies (HMA) and the 
CAMD  organised  joint  workshops  on  the  development  of  the  legal  framework  for  medical 
devices on 27 April and 28 September 2011.  

A further special meeting of the MDEG was held on 6 and 13 February 2012 to discuss issues 
related  to  the  two  legislative  proposals,  based  on  working  documents  containing  initial 
drafting  proposals.  Written  comments  made  on  these  working  documents  were  taken  in 
account for the further development of the proposals.  

In addition, the Commission’s representatives regularly participated in conferences to present 
ongoing  work  on  the  legislative  initiative  and  hold  discussions  with  stakeholders.  Targeted 
meetings  took  place  at  senior  level  with  representatives  from  associations  representing 
industry, notified bodies, healthcare professionals and patients.  

4 
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6 

OJ L 331, 7.12.1998, p. 1. 
See http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm. 
OJ L 247, 21.9.2007, p. 21. 

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Aspects linked to the appropriate regulatory framework were also discussed in the course of 
the  ‘Exploratory  Process  on  the  Future  of  the  Medical  Device  Sector’  organised  by  the 
Commission from November 2009 to January 2010. On 22 March 2011, the Commission and 
the  Hungarian  Presidency  organised  a  high-level  conference  on  innovation  in  medical 
technology,  the  role  of  the  medical  device  sector  in  addressing  the  healthcare  challenges 
facing Europe and the appropriate regulatory framework for this sector to meet the needs of 
tomorrow.  This  conference  was  followed  by  Conclusions  of  the  Council  of  the  European 
Union on innovation in the medical device sector adopted on 6 June 20117. In its Conclusions, 
the Council requested the Commission to adapt the EU medical device legislation to the needs 
of  tomorrow  so  as  to  achieve  a  suitable,  robust,  transparent  and  sustainable  regulatory 
framework,  which  is  central  to  fostering  the  development  of  safe,  effective  and  innovative 
medical devices for the benefit of European patients and healthcare professionals. 

Triggered  by  the  PIP  breast  implants  scandal,  the  European  Parliament  adopted  on  14  June 
2012 a Resolution on defective silicone gel breast implants made by the French company PIP8 
also  calling  on  the  Commission  to  develop  an  adequate  legal  framework  to  guarantee  the 
safety of medical technology. 

3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Scope and definitions (Chapter I) 

The scope of the proposed Regulation corresponds to a large extent to the combined scopes of 
Council Directives 90/385/EEC and 93/42/EEC, i.e. it covers all medical devices other than in 
vitro  diagnostic  medical  devices.  On  the  one hand,  however,  the  scope  is  extended  to  some 
products currently not covered by the AIMDD/MDD. And on the other hand, some products 
which,  in  some  Member  States,  are  placed  on  the  market  as  medical  devices  are  excluded 
from its scope.  

The extension of the scope concerns:  

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products  manufactured  utilising  non-viable  human  tissues  or  cells,  or  their 
derivatives,  that  have  undergone  substantial  manipulation  (e.g.  syringes  prefilled 
with human collagen), unless they are covered by Regulation (EC) No 1394/2007 on 
advanced therapy medicinal products9. Human tissues and cells, or products derived 
from  human  tissues  or  cells,  that  are  not  substantially  manipulated  and  that  are 
regulated by Directive 2004/23/EC of the European Parliament and of the Council of 
31  March  2004  on  setting  standards  of  quality  and  safety  for  the  donation, 
procurement,  testing,  processing,  preservation,  storage  and  distribution  of  human 
tissues and cells10 are not covered by the proposal;  

certain  implantable  or  other  invasive  products  without  a  medical  purpose  that  are 
similar  to  medical  devices  in  terms  of  characteristics  and  risk  profile  (e.g.  non-
corrective contact lenses, implants for aesthetic purposes); 

of 

OJ C 202, 8.7.2011, p. 7. 
Resolution 
http://www.europarl.europa.eu/plenary/en/texts-adopted.html. 
OJ L 324, 10.12.2007, p. 121. 
OJ L 102, 7.4.2004, p. 48. 

2012 

June 

14 

(2012/2621(RSP)); 

P7_TA-PROV(2012)0262, 

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Additional  provisions  as  regards  products  that  are  not  covered  by  the  Regulation  have  been 
included, more to clarify the scope with a view to ensuring harmonised implementation than 
to substantially change the scope of the EU legislation. They concern: 

• 

• 

products  that  contain  or  consist  of  viable  biological  substances  (e.g.  living  micro-
organisms); 

food  covered  by  Regulation  (EC)  No  178/2002  on  general  principles  and 
requirements of food law11 (e.g. this may affect certain slimming products); in return, 
medical  devices  are  excluded  from  the  scope  of  Regulation  178/2002  (diagnostic 
probes or cameras, even when introduced orally, are therefore clearly excluded from 
the food legislation).  

As regards products composed of substances or combinations of substances that are intended 
to  be  ingested,  inhaled  or  administered  rectally  or  vaginally  and  that  are  absorbed  by  or 
dispersed in the human body, the borderline between medicinal products and medical devices 
is  difficult  to  draw.  To  ensure  a  high  level  of  safety  of  those  products  regardless  of  their 
qualification, those products which fall under the definition of a medical device are classified 
in  the  highest  risk  class  and  should  comply  with  the  relevant  requirements  of  Annex  I  of 
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on 
the Community code relating to medicinal products for human use12. 

To  support  Member  States  and  the  Commission  in  determining  the  regulatory  status  of 
products,  the  Commission  may  set  up,  in  accordance  with  its  internal  rules13,  a  group  of 
experts  from  various  sectors  (such  as  medical  devices,  IVDs,  medicinal  products,  human 
tissues and cells, cosmetics and biocides).  

The definitions section has been significantly extended, aligning the definitions in the field of 
medical devices with well established European and international practice, such as the New 
Legislative Framework for the Marketing of Products14 and guidance documents produced by 
the Global Harmonization Task Force (GHTF) for medical devices15. 

3.2.  Making  available  of  devices,  obligations  of  economic  operators,  reprocessing, 

CE marking, free movement (Chapter II) 

This chapter contains provisions that are typical for product-related internal market legislation 
and  sets  out  the  obligations  of  the  relevant  economic  operators  (manufacturers,  authorised 
representatives  of  non-EU  manufacturers,  importers  and  distributors).  The  regulatory 
instrument of ‘common technical specification’ (CTS), which has proven useful in the context 
of  the  IVDD,  has  been  introduced  in  the  broader  field  of  medical  devices  to  allow  the 
Commission to further specify the general safety and performance requirements (laid down in 

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OJ L 31, 1.2.2002, p. 1.  
OJ L 311, 28.11.2001, p. 67. 
Communication  from  the  President  to  the  Commission  of  10.11.2010,  Framework  for  Commission 
Expert Groups: Horizontal Rules and Public Registers, C(2010)7649 final. 
Consisting of Regulation (EC) No 765/2008 of the European Parliament and of the Council setting out 
the  requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of  products  and 
repealing Regulation (EEC) No 339/93, OJ L 218, 13.8.2008, p. 30, and Decision No 768/2008/EC of 
the  European  Parliament  and  of  the  Council  on  a  common  framework  for  the  marketing  of  products, 
and repealing Council Decision 93/465/EEC, OJ L 218, 13.8.2008, p. 82.  
http://www.ghtf.org/ 

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Annex I) and the requirements on clinical evaluation and post-market clinical follow-up (laid 
down  in  Annex  XIII).  Such  requirements  however,  leave  manufacturers  the  possibility  of 
adopting other solutions that ensure at least an equivalent level of safety and performance. 

The legal obligations on manufacturers are proportionate to the risk class of the devices they 
produce.  For  example,  this  means  that  even though  all  manufacturers  should  have  a  quality 
management  system  (QMS)  in  place  to  ensure  that  their  products  consistently  meet  the 
regulatory  requirements,  the  QMS-related  responsibilities  are  stricter  for  manufacturers  of 
high  risk  devices  than  for  manufacturers  of  low  risk  devices.  Manufacturers  of  medical 
devices  for  an  individual  patient,  so  called  ‘custom-made  devices’,  must  ensure  that  their 
devices are safe and perform as intended, but their regulatory burden remains low. 

Key documents for the manufacturer to demonstrate compliance with the legal requirements 
are  the  technical  documentation  and  the  EU  declaration  of  conformity  to  be  drawn  up  in 
respect of devices placed on the market. Their minimum contents are laid down in Annexes II 
and III.  

The following concepts are also new in the field of medical devices:  

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• 

• 

• 

16 

A  requirement  has  been  introduced  that  within  the  manufacturer’s  organisation  a 
'qualified  person'  should  be  responsible  for  regulatory  compliance.  Similar 
requirements exist in EU legislation on medicinal products and in the national laws 
transposing the AIMDD/MDD in some Member States.  

Since in the case of 'parallel trade' with medical devices application of the principle 
of  free  movement  of  goods  varies  considerably  from  one  Member  State  to  another 
and,  in  many  cases,  de  facto  prohibits  this  practice,  clear  conditions  are  set  for 
enterprises involved in relabelling and/or repackaging medical devices. 

Patients  who  are  implanted  with  a  device  should  be  given  essential  information  on 
the  implanted  device  allowing  it  to  be  identified  and  containing  any  necessary 
warnings or precautions to be taken, for example indication as to whether or not it is 
compatible  with  certain  diagnostic  devices  or  with  scanners  used  for  security 
controls. 

In  accordance  with  Article  12a  of  the  MDD,  introduced  by  Directive  2007/47/EC, 
the Commission had to prepare a report on the reprocessing of medical devices and 
submit,  where  appropriate,  a  legislative  proposal  on  this  issue.  On  the  basis  of  the 
Commission's  findings  set  out  in  its  report  of  27  August  201016,  which  took  into 
account the opinion of the Scientific Committee on Emerging and Newly Identified 
Health Risks (SCENIHR) of 15 April 2010, the proposal contains strict rules on the 
reprocessing  of  single-use  devices  in  order  to  ensure  a  high  level  of  protection  of 
health  and  safety  whilst  allowing  this  practice  to  further  develop  under  clear 
conditions. Reprocessing of single-use devices is considered as manufacture of new 
devices  so  that  the  reprocessors  must  satisfy  the  obligations  incumbent  on 
manufacturers.  The  reprocessing  of  single-use  devices  for  critical  use  (e.g.  devices 

Report from the Commission to the European Parliament and the Council on the issue of reprocessing 
of  medical  devices  in  the  European  Union,  in  accordance  with  Article  12a  of  Directive  93/42/EEC, 
COM(2010)443 final. 

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for  surgically  invasive  procedures)  should,  as  a  general  rule,  be  prohibited.  Since 
certain Member States may have particular concerns in terms of safety regarding the 
reprocessing  of  single-use  devices,  they  retain  their  right  to  maintain  or  impose  a 
general  ban  on  this  practice  including  the  transfer  of  single-use  devices  to  another 
Member  State  or  to  a  third  country  with  a  view  to  their  reprocessing  and  on  the 
access of reprocessed single-use devices to their market. 

3.3. 

Identification  and  traceability  of  devices,  registration  of  devices  and  economic 
operators, summary of safety and clinical performance, Eudamed (Chapter III) 

This  chapter  addresses  one  of  the  main  shortcomings  of  the  current  system:  its  lack  of 
transparency. It consists of:  

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• 

• 

• 

• 

a  requirement  that  economic  operators  must  be  able  to  identify  who  supplied  them 
and to whom they have supplied medical devices; 

a  requirement  that  manufacturers  fit  their  devices  with  a  Unique  Device 
Identification (UDI) which allows traceability. The UDI system will be implemented 
gradually and proportionate to the risk class of the devices; 

a  requirement  that  manufacturers/authorised  representatives  and  importers  must 
register  themselves  and  the  devices  they  place  on  the  EU  market  in  a  central 
European database; 

an  obligation  for  manufacturers  of  high-risk  devices  to  make  publicly  available  a 
summary  of  safety  and  performance  with  key  elements  of  the  supporting  clinical 
data;  

and  the  further  development  of  the  European  databank  on  medical  devices 
(Eudamed),  set  up  by  Commission  Decision  2010/227/EU17,  which  will  contain 
integrated electronic systems on a European UDI, on registration of devices, relevant 
economic  operators  and  certificates 
issued  by  notified  bodies,  on  clinical 
investigations,  on  vigilance  and  on  market  surveillance.  A  large  part  of  the 
information  in  Eudamed  will  become  publicly  available  in  accordance  with  the 
provisions regarding each electronic system.  

The  establishment  of  a  central  registration  database  will  not  only  provide  a  high  level  of 
transparency but also do away with diverging national registration requirements which have 
emerged  over  recent  years  and  which  have  significantly  increased  compliance  costs  for 
economic operators. It will therefore also contribute to reducing the administrative burden on 
manufacturers.  

3.4. 

Notified bodies (Chapter IV)  

Proper functioning of notified bodies is crucial for ensuring a high level of health and safety 
protection  and  citizens'  confidence  in  the  system  which  has  come  under  severe  criticism  in 
recent  years  due  to  significant  differences  as  regards,  on  the  one  hand,  the  designation  and 
monitoring  of  notified  bodies  and,  on  the  other,  the  quality  and  depth  of  the  conformity 

17 

OJ L 102, 23.4.2010, p. 45.  

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assessment performed by them, in particular in their assessment of the manufacturers' clinical 
evaluation.  

In line with the New Legislative Framework for the Marketing of Products, the proposal sets 
out requirements for national authorities responsible for notified bodies. It leaves the ultimate 
responsibility  for  designating  and  monitoring  notified  bodies,  based  on  stricter  and  detailed 
criteria laid down in Annex VI, with the individual Member State. The proposal thus builds 
on  existing  structures  already  available  in  most  Member  States  instead  of  lifting  the 
responsibility to the Union level which might have caused concerns in terms of subsidiarity. 
But any new designation and, in regular intervals, the monitoring of notified bodies are made 
subject  to  ‘joint  assessments’  with  experts  from  other  Member  States  and  the  Commission, 
thus ensuring an effective control at Union level.  

At the same time, the position of notified bodies vis-à-vis manufacturers will be significantly 
strengthened, including their right and duty to carry out unannounced factory inspections and 
to conduct physical or laboratory tests on devices. The proposal also requires rotation of the 
notified  body's  personnel  involved  in  the  assessment  of  medical  devices  at  appropriate 
intervals  to  strike  a  reasonable  balance  between  the  knowledge  and  experience  required  to 
carry out thorough assessments and the need to ensure continuous objectivity and neutrality in 
relation to the manufacturer subject to those assessments. 

3.5. 

Classification and conformity assessment (Chapter V)  

The  proposal  keeps  to  the  well  established  approach  (in  Europe  and  internationally)  of 
dividing  medical  devices  into  four  classes,  taking  account  of  the  potential  risks  associated 
with the technical design and manufacture. The classification rules (laid down in Annex VII) 
have  been  adapted  to  technical  progress  and  experience  gained  from  vigilance  and  market 
surveillance. For example, further to incidents that had occurred to blood plasma donors and a 
request submitted by France, aphaeresis machines have been moved from class IIb to class III. 
Active implantable medical devices and their accessories have been classified in the highest 
risk  class  (class  III)  to  maintain  the  same  level  of  safety  as  provided  by  Council  Directive 
90/385/EEC.  

The  classification  of  a  medical  device  determines  the  applicable  conformity  assessment 
procedure  for  which  the  proposal  follows  the  general  lines  of  the  AIMDD/MDD.  The 
conformity  assessment  procedure  for  class  I  devices  can  be  carried  out,  as  a  general  rule, 
under  the  sole  responsibility  of  the  manufacturer  in  view  of  the  low  level  of  vulnerability 
associated with these products. However, when class I devices have a measuring function or 
are sold sterile, a notified body must verify the aspects related to the measuring function or to 
the  sterilisation  process.  For  devices  of  classes  IIa,  IIb  and  III,  an  appropriate  level  of 
involvement of a notified body is compulsory proportionate to the risk class, with devices of 
class III requiring explicit prior approval of the design or of the type of the device and of the 
quality management system before they may be placed on the market. In the case of class IIa 
and  IIb  devices,  the  notified  body  checks  the  quality  management  system  and,  for 
representative samples, the technical documentation. After initial certification, notified bodies 
must regularly conduct surveillance assessments in the post-market phase.  

The  different  conformity  assessment  procedures  during  which  the  notified  body  audits  the 
manufacturer's  quality  management  system,  checks  the  technical  documentation,  examines 
the design dossier or approves the type of a device are laid down in Annexes VIII to X. They 
have been tightened and streamlined. The proposal reinforces the powers and responsibilities 

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of  notified  bodies  and  specifies  the  rules  according  to  which  notified  bodies  perform  their 
assessments,  both  in  the  pre-market  and  the  post-market  phase  (e.g.  documentation  to  be 
submitted,  scope  of  the  audit,  unannounced  factory  inspections,  sample  checks)  to  ensure  a 
level playing field and avoid notified bodies being overly lenient. Manufacturers of custom-
made devices continue to be subject to a specific procedure (laid down in Annex XI) which 
does not involve a notified body.  

In  addition,  the  proposal  introduces  the  obligation  for  notified  bodies  to  notify  an  expert 
committee (see below under 3.8.) of new applications for conformity assessment of high-risk 
devices. On scientifically valid health grounds, the expert committee will have the power to 
request  the  notified  body  to  submit  a  preliminary  assessment  on  which  the  committee  can 
issue comments within a deadline of 60 days18, before the notified body can issue a certificate. 
This  scrutiny  mechanism  empowers  the  authorities  to  have  a  'second  look'  at  individual 
assessments  and  make  their  views  heard  before  a  device  is  placed  on  the  market.  A  similar 
procedure  is  currently  already  applied  for  medical  devices  manufactured  utilising  animal 
tissues (Commission Directive 2003/32/EC19). Its use should be the exception rather than the 
rule and should follow clear and transparent criteria.  

3.6. 

Clinical evaluation and clinical investigations (Chapter VI)  

Building on the current Annex X of the MDD, this chapter lays down the key obligations of 
manufacturers as regards the performance of the clinical evaluation needed to demonstrate the 
safety and performance of their devices. More detailed requirements are set out in Annex XIII 
which  addresses  the  pre-market  clinical  evaluation  and  post-market  clinical  follow-up  that 
together constitute a continuous process during the life cycle of a medical device. 

The process for conducting clinical investigations (the equivalent of clinical trials in the field 
of medicinal products), which is currently described in basic terms in Article 15 of the MDD, 
is further developed. First of all, the concept of ‘sponsor’ is introduced and aligned with the 
definition  used  in  the  recent  Commission's  Proposal  for  a  Regulation  of  the  European 
Parliament and of the Council on clinical trials on medicinal products for human use which 
aims at repealing Directive 2001/20/EC20. 

The sponsor can be the manufacturer, his authorised representative or another organisation, in 
practice  often  a  ‘contract  research  organisation’  conducting  clinical  investigations  for  the 
manufacturers.  The  scope  of  the  proposal,  however,  remains  restricted  to  clinical 
investigations carried out for regulatory purposes, i.e. for obtaining or confirming regulatory 
approval  for  market  access.  Non-commercial  clinical  investigations  that  do  not  pursue  a 
regulatory purpose are not covered by this Regulation. 

In  accordance  with  recognised  international  ethical  principles,  every  clinical  investigation 
must be registered in a publicly accessible electronic system which the Commission will set 
up. To ensure synergies with the area of clinical trials on medicinal products, the electronic 
system on clinical investigations on medical devices should be interoperable with the future 

18 

19 

20 

In accordance with Article 3(3) of Regulation (EEC, EURATOM) No 1182/71 of the Council of 3 June 
1971 determining the rules applicable to periods, dates and time limits, OJ L 124, 8.6.1971, p. 1) days 
referred to in this Regulation mean calendar days. 
OJ  L  105,  26.4.2003,  p.  18.  This  directive  will  be  replaced  by  Commission  Regulation  (EU)  No 
722/2012 (OJ L 212, 9.8.2012, p. 3) with effect from 29 August 2013.  
COM(2012)369. 

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EU  database  to  be  set  up  in  accordance  with  the  future  Regulation  on  clinical  trials  on 
medicinal products for human use.  

Before  commencing  a  clinical  investigation,  the  sponsor  must  submit  an  application  to 
confirm that there are no health and safety or ethical aspects which would oppose it. A new 
possibility will be opened up for sponsors of clinical investigations to be conducted in more 
than one Member State: in future, they may submit a single application through the electronic 
system  to  be  set  up  by  the  Commission.  As  a  consequence,  the  health  and  safety  aspects 
regarding the device intended for clinical investigation will be assessed by the Member States 
concerned under the direction of a coordinating Member State. The assessment of intrinsically 
national,  local  and  ethical  aspects  (e.g.  liability,  suitability  of  the  investigators  and 
investigation sites, informed consent) will, however, need to be carried out at the level of each 
Member State concerned which will retain the ultimate responsibility for deciding whether the 
clinical  investigation  may  be  conducted  on  its  territory.  In  line  with  the  above-mentioned 
Commission's  Proposal  for  a  Regulation  on  clinical  trials  on  medicinal  products,  also  this 
proposal leaves it to the Member States to define the organisational set-up at national level for 
the approval of clinical investigations. In other words, it moves away from a legally required 
dualism of two distinct bodies, i.e. a national competent authority and an ethics committee. 

3.7. 

Vigilance and market surveillance (Chapter VII)  

A well functioning vigilance system is the 'backbone' of a robust regulatory framework in this 
sector  because  complications  with  medical  devices  that  are  designed  to  be  implanted  or  to 
operate  for  many  years  or  even  decades  might  come  to  light  only  after  a  certain  period  of 
time. The main progress which the proposal will bring in this field is the introduction of an 
EU portal where manufacturers must report serious incidents and corrective actions they have 
taken to reduce the risk of recurrence. The information will be automatically forwarded to the 
national authorities concerned. Where the same or similar incidents have occurred, or where a 
corrective  action  has  to  be  taken,  in  more  than  one  Member  State,  a  coordinating  authority 
will  take  the  direction  in  coordinating  the  analysis  of  the  case.  The  emphasis  is  placed  on 
work- and expertise-sharing to avoid inefficient duplication of procedures.  

As regards market surveillance, the main objectives of the proposal are to reinforce the rights 
and obligations of the national competent authorities, to ensure effective coordination of their 
market surveillance activities and to clarify the applicable procedures. 

3.8. 

Governance (Chapters VIII and IX)  

The Member States will be responsible for implementation of the future Regulation. A central 
role  in  achieving  harmonised  interpretation  and  practice  will  be  assigned  to  an  expert 
committee  (the  Medical  Device  Coordination  Group  or  MDCG)  made  up  of  members 
appointed  by  the  Member  States  due  to  their  role  and  experience  in  the  field  of  medical 
devices and chaired by the Commission. The MDCG and its subgroups will allow to build a 
forum for discussions with stakeholders. The proposal creates the legal basis that for specific 
hazards or technologies EU reference laboratories, a concept that has proven successful in the 
food sector, may in the future be designated by the Commission. 

As regards the management at EU level, the impact assessment identified as preferred policy 
options either the extension of the responsibility of the European Medicines Agency (EMA) 
to  medical  devices  or  the  management  of  the  medical  devices  regulatory  system  by  the 
Commission.  Taking  into  account  the  clear  preference  expressed  by  stakeholders,  including 

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many Member States, the proposal mandates the Commission to provide technical, scientific 
and logistic support to the MDCG. 

3.9. 

Final provisions (Chapter X)  

The  proposal  empowers  the  Commission  to  adopt,  where  appropriate,  either  implementing 
acts  to  ensure  uniform  application  of  the  Regulation  or  delegated  acts  to  complement  the 
regulatory framework for medical devices over time. 

With  this  proposal,  other  Union  legislation  is  amended  where  a  link  exists  with  medical 
devices.  In  the  case  of  medicinal  product/medical  device  combination  products  that  are 
regulated under Directive 2001/83/EC, the AIMDD and MDD already require the device part 
to comply with the applicable essential requirements set out in the medical device legislation. 
However,  compliance  with  this  requirement  is  not  currently  verified  as  part  of  the 
authorisation process for the medicinal product. Annex I of Directive 2001/83/EC, which lays 
down  the  content  of  an  application  for  marketing  authorisation,  is  therefore  amended  to 
require the applicant to submit evidence (e.g. an EU declaration of conformity or a certificate 
issued  by  a  notified  body)  that  the  device  part  is  in  conformity  with  the  applicable  general 
safety and performance requirements of the future Regulation on medical devices.  

Regulation  (EC)  No  1223/2009  of  the  European  Parliament  and  of  the  Council  of  30 
November 2009 on cosmetic products21 is amended to empower the Commission to determine 
whether  or  not  a  product  falls  within  the  definition  of  a  cosmetic  product.  Such  possibility 
already exists in the AIMDD and the MDD and is kept in this proposal. It also exists in the 
new Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 
2012 concerning the making available on the market and use of biocidal products22. This will 
facilitate the adoption of EU-wide decisions regarding 'borderline' cases where the regulatory 
status of a product needs to be clarified. 

The  Food  Regulation  178/2002  is  amended  to  exclude  medical  devices  from  its  scope  (see 
3.1. above).  

The  new  Regulation  will  become  applicable  three  years  after  its  entry  into  force  to  allow 
manufacturers, notified bodies and Member States time to adapt to the new requirements. The 
Commission  needs  time  to  put  in  place  the  IT  infrastructure  and  the  organisational 
arrangements necessary for the functioning of the new regulatory system. The designation of 
notified bodies pursuant to the new requirements and process needs to start shortly after the 
entry  into  force  of  the  Regulation  in  order  to  ensure  that  by  the  date  of  its  application, 
sufficient  notified  bodies  are  designated  in  accordance  with  the  new  rules  to  avoid  any 
shortage of medical devices on the market. Special transitional provisions are foreseen for the 
registration  of  medical  devices,  relevant  economic  operators  and  certificates  issued  by 
notified  bodies  to  allow  for  a  smooth  transition  from  registration  requirements  at  national 
level to a central registration at EU level. 

The future Regulation replaces and repeals Council Directives 90/385/EEC and 93/42/EEC.  

21 
22 

OJ L 342, 22.12.2009, p. 59.  
OJ L 167, 27.6.2012, p.1.  

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3.10.  Union competence, subsidiarity and legal form  

The proposal has a ‘double legal basis‘, i.e. Article 114 and Article 168(4)(c) of the Treaty on 
the  Functioning  of  the  European  Union  (TFEU).  With  the  entry  into  force  of  the  Lisbon 
Treaty, the legal base for the establishment and functioning of the internal market, on which 
the current Medical Devices Directives were adopted, has been complemented by a specific 
legal  basis  to  set  high  standards  for  the  quality  and  safety  of  devices  for  medical  use.  In 
regulating medical devices, the Union is exercising its shared powers under Article 4(2) of the 
TFEU.  

Under  the  current  Medical  Devices  Directives,  devices  that  bear  the  CE  marking  can,  in 
principle, move freely within the EU. The proposed revision of the existing directives, which 
will  integrate  the  changes  introduced  by  the  Lisbon  Treaty  regarding  public  health,  can  be 
achieved only at Union level. This is necessary in order to improve the level of protection of 
public  health  for  all  European  patients  and  users,  and  also  to  prevent  Member  States  from 
adopting  diverging  product  regulations  which  would  result  in  further  fragmentation  of  the 
internal  market.  Harmonised  rules  and  procedures  allow  manufacturers,  especially  SMEs 
which  make  up  more  than  80%  of  the  sector,  to  reduce  costs  related  to  national  regulatory 
differences,  while  ensuring  a  high  and  equal  level  of  safety  throughout  the  Union.  In 
accordance with the principles of proportionality and subsidiarity, as set out in Article 5 of the 
Treaty  on  European  Union,  this  proposal  does  not  go  beyond  what  is  necessary  in  order  to 
achieve those objectives.  

The  proposal  takes  the  form  of  a  Regulation.  This  is  the  appropriate  legal  instrument  as  it 
imposes clear and detailed rules which will become applicable in a uniform manner and at the 
same  time  throughout  the  Union.  Diverging  transposition  of  the  AIMDD  and  MDD  by 
Member States has led to different levels of health and safety protection and created obstacles 
to the internal market which only a Regulation can avoid. Replacing the national transposition 
measures also has a strong simplification effect since it allows economic operators to conduct 
their business on the basis of a single regulatory framework, rather than a 'patchwork' of 27 
national laws. 

The  choice  of  a  Regulation,  however,  does  not  mean  that  decision-making  is  centralised. 
Member States retain their competence for implementing the harmonised rules, e.g. as regards 
approval  of  clinical  investigations,  the  designation  of  notified  bodies,  the  assessment  of 
vigilance cases, the conduct of market surveillance and enforcement action (e.g. penalties).  

3.11. 

Fundamental Rights 

In line with the Charter of Fundamental Rights of the EU, this proposal seeks to ensure a high 
level of human health protection (Article 35 of the Charter) and consumer protection (Article 
38) by assuring a high level of safety of medical devices made available on the Union market. 
The proposal affects the freedom of economic operators to conduct business (Article 16) but 
the  obligations  imposed  on  manufacturers,  authorised  representatives,  importers  and 
distributors  of  medical  devices  are  necessary  to  guarantee  a  high  level  of  safety  of  those 
products.  

The  proposal  sets  guarantees  for  the  protection  of  personal  data.  In  respect  to  medical 
research,  the  proposal  requires  that  any  clinical  investigation  with  participation  of  human 
subjects is conducted respecting the human dignity, the right to physical and mental integrity 

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of  the  persons  concerned  and  the  principle  of  free  and  informed  consent,  as  required  by 
Articles 1, 3(1) and 3(2)(a) of the Charter. 

4. 

BUDGETARY IMPLICATIONS 

The budgetary implications of this proposal are as follows: 

• 

• 

• 

• 

• 

• 

• 

• 

• 

Costs  for  the  further  development  of  the  Eudamed  databank  (one-off  costs  and 
maintenance); 

Commission staff to organise and participate in 'joint assessments' of notified bodies;  

Costs for national assessors participating in 'joint assessments' of notified bodies in 
accordance with the Commission's rules on the reimbursement of expenses incurred 
by experts; 

Commission staff to provide scientific, technical and logistic support to the MDCG, 
to  its  sub-groups  and  to  the  coordinating  Member  States  in  the  fields  of  clinical 
investigations and vigilance; 

Commission  staff  to  manage  and  further  develop  the  EU  regulatory  framework  for 
medical  devices 
and  preparation  of 
delegated/implementing acts) and to support Member States in ensuring its effective 
and efficient implementation; 

this  Regulation 

(functioning  of 

Costs  for  organising  meetings  of  the  MDCG  and  its  sub-groups  and  of  the 
Committee under Regulation 182/2011, including reimbursement of their members, 
appointed  by  the  Member  States,  to  ensure  a  high  level  of  coordination  between 
Member States; 

Costs for the establishment and management of the scrutiny mechanism in respect of 
conformity  assessments  by  notified  bodies  for  high  risk  devices,  including  the 
technical infrastructure for data-exchange;  

Costs for running EU reference laboratories when these are designated;  

Costs for participation in international regulatory cooperation.  

Details of the costs are set out in the legislative financial statement. A thorough discussion on 
the costs is contained in the impact assessment report. 

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2012/0266 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 
and Regulation (EC) No 1223/2009 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 114 and Article 168(4)(c) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee23,  

Having regard to the opinion of the Committee of the Regions24,  

After consulting the European Data Protection Supervisor25, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

Council  Directive  90/385/EEC of  20 June 1990 on  the approximation of  the  laws of 
the  Member  States  relating  to  active  implantable  medical  devices26  and  Council 
Directive  93/42/EEC  of  14  June  1993  concerning  medical  devices27  constitute  the 
Union  regulatory  framework  for  medical  devices,  other  than  in  vitro  diagnostic 
medical  devices.  However,  a  fundamental  revision  of  those  Directives  is  needed  to 
establish  a  robust,  transparent,  predictable  and  sustainable  regulatory  framework  for 
medical  devices  which  ensures  a  high  level  of  safety  and  health  whilst  supporting 
innovation. 

23 
24 
25 
26 
27 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 189, 20.7.1990, p. 17.  
OJ L 169, 12.7.1993, p. 1. 

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(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

This  Regulation  aims  to  ensure  the  functioning  of  the  internal  market  as  regards 
medical devices, taking as a base a high level of protection of health. At the same time, 
this Regulation sets high standards of quality and safety for medical devices to meet 
common safety concerns as regards these products. Both objectives are being pursued 
simultaneously and are inseparably linked whilst one not being secondary to the other. 
As regards Article 114 TFEU, this Regulation harmonises the rules for the placing on 
the  market  and  putting  into  service  of  medical  devices  and  their  accessories  on  the 
Union market which may then benefit from the principle of free movement of goods. 
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and 
safety for those medical devices by ensuring, among other things, that data generated 
in  clinical  investigations  is  reliable  and  robust  and  that  the  safety  of  the  subjects 
participating in a clinical investigation is protected. 

Key elements of the existing regulatory approach, such as the supervision of notified 
bodies,  conformity  assessment  procedures,  clinical  investigations  and  clinical 
evaluation, vigilance and market surveillance should be significantly reinforced, whilst 
provisions  ensuring  transparency  and  traceability  regarding  devices  should  be 
introduced, to improve health and safety.  

To the extent possible, guidance developed for medical devices at international level, 
in  particular  in  the  context  of  the  Global  Harmonization  Task  Force  (GHTF)  and  its 
follow-up  initiative  the  International  Medical  Devices  Regulators  Forum,  should  be 
taken into account to promote the global convergence of regulations which contributes 
to a high level of safety protection worldwide and to facilitate trade, in particular in the 
provisions  on  Unique  Device  Identification,  general  safety  and  performance 
requirements,  technical  documentation,  classification  criteria,  conformity  assessment 
procedures and clinical investigations.  

For  historic  reasons  active  implantable  medical  devices,  covered  by  Directive 
90/385/EEC,  and  other  medical  devices,  covered  by  Directive  93/42/EEC,  were 
regulated  in  two  separate  legal  instruments.  In  the  interest  of  simplification,  both 
directives,  which  have  been  amended  several  times,  should  be  replaced  by  a  single 
legislative act applicable to all medical devices other than in vitro diagnostic medical 
devices. 

A Regulation is the appropriate legal instrument as it imposes clear and detailed rules 
which  do  not  give  room  for  divergent  transposition  by  Member  States.  Moreover,  a 
Regulation  ensures  that  legal  requirements  are  implemented  at  the  same  time 
throughout the Union.  

The  scope  of  application  of  this  Regulation  should  be  clearly  delimited  from  other 
Union  harmonisation  legislation  concerning  products,  such  as  in  vitro  diagnostic 
medical devices, medicinal products, cosmetics and food. Therefore, Regulation (EC) 
No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European 
Food Safety Authority and laying down procedures in matters of food safety28 should 
be amended to exclude medical devices from its scope. 

28 

OJ L 31, 1.2.2002, p.1. 

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(8) 

(9) 

It should be the responsibility of the Member States to decide on a case-by-case basis 
whether  or  not  a  product  falls  within  the  scope  of  this  Regulation.  If  necessary,  the 
Commission may decide, on a case-by-case basis, whether or not a product falls within 
the  definition  of  a  medical  device  or  of  an  accessory  to  a  medical  device.  Since  in 
some  cases  it  is  difficult  to  distinguish  between  medical  devices  and  cosmetic 
products, the possibility to take an EU-wide decision regarding the regulatory status of 
a  product  should  also  be  introduced  in  Regulation  No  1223/2009  of  the  European 
Parliament and of the Council of 30 November 2009 on cosmetic products29.  

Products which combine a medicinal product or substance and a medical device, are 
regulated either under this Regulation or under Directive 2001/83/EC of the European 
Parliament and of the Council of 6 November 2001 on the Community code relating to 
medicinal products for human use30. It should be ensured that appropriate interaction 
exists between the two legislative acts in terms of consultations during the pre-market 
assessment  and  exchange  of  information  on  vigilance  cases  occurring  with 
combination  products.  For  medicinal  products  that  integrate  a  medical  device  part, 
compliance  with  the  general  safety  and  performance  requirements  of  the  device  part 
should be adequately assessed in the context of the marketing authorisation. Directive 
2001/83/EC should therefore be amended. 

(10)  Union  legislation  is  incomplete  in  respect  of  certain  products  manufactured  utilising 
non-viable  human  tissues  or  cells  that  have  undergone  substantial  manipulation  and 
that  are  not  covered  by  Regulation  (EC)  No  1394/2007  of  the  European  Parliament 
and of the Council of 13 November 2007 on advanced therapy medicinal products and 
amending  Directive  2001/83/EC  and  Regulation  (EC)  No  726/200431.  Whilst 
donation,  procurement  and  testing  of  the  human  tissues  and  cells  used  for  the 
manufacture  of  those  products  should  remain  within  the  scope  of  Directive 
2004/23/EC  of  the  European  Parliament  and  of  the  Council  of  31  March  2004  on 
setting  standards  of  quality  and  safety  for  the  donation,  procurement,  testing, 
processing,  preservation,  storage  and  distribution  of  human  tissues  and  cells32,  the 
finished product should come under the scope of this Regulation. Human tissues and 
cells that are not substantially manipulated, such as human demineralised bone matrix, 
and  products  derived  from  such  tissues  and  cells,  should  not  be  covered  by  this 
Regulation. 

(11)  Certain  implantable  and  other  invasive  products  for  which  the  manufacturer  claims 
only  an  aesthetic  or  another  non-medical  purpose  but  which  are  similar  to  medical 
devices in terms of functioning and risks profile should be covered by this Regulation.  

(12)  Like  for  products  that  contain  viable  tissues  or  cells  of  human  or  animal  origin,  that 
are  explicitly  excluded  from  Directives  90/385/EEC  and  93/42/EEC  and  hence  from 
this  Regulation,  it  should  be  clarified  that  products  that  contain  living  biological 
substances of other origin are also not covered by this Regulation. 

(13)  There  is  scientific  uncertainty  about  the  risks  and  benefits  of  nanomaterials  used  for 
medical devices. In order to ensure a high level of health protection, free movement of 

29 
30 
31 
32 

OJ L 342, 22.12.2009, p. 59. 
OJ L 311, 28.11.2001, p. 67. 
OJ L 324, 10.12.2007, p. 121. 
OJ L 102, 7.4.2004, p. 48. 

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goods  and  legal  certainty  for  manufacturers,  it  is  necessary  to  introduce  a  uniform 
definition for nanomaterials based on Commission Recommendation 2011/696/EU of 
18 October 2011 on the definition of nanomaterial33, with the necessary flexibility to 
adapt  this  definition  to  scientific  and  technical  progress  and  subsequent  regulatory 
development  at  Union  and  international  level.  In  the  design  and  manufacture  of 
medical devices, the manufacturers should take special care when using nanoparticles 
that can be released to the human body and those devices should be subject to the most 
severe conformity assessment procedure. 

(14)  Aspects  addressed  by  Directive  2004/108/EC  of  the  European  Parliament  and  of  the 
Council of 15 December 2004 on the approximation of the laws of the Member States 
relating  to  electromagnetic  compatibility  and  repealing  Directive  89/336/EEC34  and 
aspects  addressed  by  Directive  2006/42/EC  of  the  European  Parliament  and  of  the 
Council  of  17  May  2006  on  machinery  and  amending  Directive  95/16/EC35  are  an 
integral part of the general safety and performance requirements for medical devices. 
Consequently, this Regulation should be considered a lex specialis in relation to those 
Directives.  

(15)  This Regulation should include requirements regarding the design and manufacture of 
medical  devices  emitting  ionizing  radiation  without  affecting  the  application  of 
Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards 
for the protection of the health of workers and the general public against the dangers 
arising  from  ionising  radiation36  nor  of  Council  Directive  97/43/Euratom  of  30  June 
1997  on  health  protection  of  individuals  against  the  dangers  of  ionizing  radiation  in 
relation to medical exposure and repealing Directive 84/466/Euratom37 which pursue 
other objectives.  

(16) 

It  should  be  made  clear  that  the  requirements  of  this  Regulation  also  apply  to  the 
countries that have entered into international agreements with the Union which confer 
on  that  country  the  same  status  as  a  Member  State  for  the  purpose  of  application  of 
this  Regulation,  as  it  is  currently  the  case  with  the  Agreement  on  the  European 
Economic  Area38,  the  Agreement  between  the  European  Community  and  the  Swiss 
Confederation  on  mutual  recognition  in  relation  to  conformity  assessment39  and  the 
Agreement  of  12  September  1963  establishing  an  association  between  the  European 
Economic Community and Turkey40.  

(17) 

It should be made clear that medical devices offered to persons in the Union by means 
of  information  society  services  within  the  meaning  of  Directive  98/34/EC  of  the 
European Parliament and of the Council of 22 June 1998 laying down a procedure for 
the  provision  of  information  in  the  field  of  technical  standards  and  regulations41  as 
well as devices used in the context of a commercial activity to provide a diagnostic or 

33 
34 
35 
36 
37 
38 
39 
40 
41 

OJ L 275, 20.10.2011, p. 38. 
OJ L 390, 31.12.2004, p. 24 
OJ L 157, 9.6.2006, p. 24. 
OJ L 159, 29.6.1996, p. 1. 
OJ L 180, 9.7.1997, p. 22. 
OJ L 1, 3.1.1994, p. 3. 
OJ L 114, 30.4.2002, p. 369. 
OJ 217, 29.12.1964, p. 3687. 
OJ L 204, 21.7.1998, p. 37, as amended by Directive 98/48/EC of the European Parliament and of the 
Council of 20 July 1998, OJ L 217, 5.8.1998, p. 18. 

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therapeutic service to persons within the Union must comply with the requirements of 
this Regulation at the latest when the product is placed on the market or the service is 
provided in the Union. 

(18) 

It is appropriate to adapt the general safety and performance requirements to technical 
and  scientific  progress,  for  example  for  software  that  is  specifically  intended  by  the 
manufacturer  to  be  used  for  one  or  more  of  the  medical  purposes  set  out  in  the 
definition of a medical device.  

(19)  To  recognise  the  important  role  of  standardisation  in  the  field  of  medical  devices, 
compliance with  harmonised standards as defined in Regulation (EU) No […/…]  on 
European  standardisation42  should  be  a  means  for  manufacturers  to  demonstrate 
conformity  with  the  general  safety  and  performance  requirements  and  other  legal 
requirements, such as quality and risk management. 

(20)  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 
on  in  vitro  diagnostic  medical  devices43  allows  the  Commission  to  adopt  common 
technical specifications for specific categories of in vitro diagnostic medical devices. 
In  areas  where  no  harmonised  standards  exist  or  where  they  are  not  sufficient,  the 
Commission should be empowered to lay down technical specifications which provide 
a  means  to  comply  with  general  safety  and  performance  requirements  and 
requirements for clinical evaluation and/or post-market clinical follow-up.  

(21)  The  definitions  in  the  field  of  medical  devices,  for  example  regarding  economic 
operators,  clinical  investigations  and  vigilance,  should  be  aligned  with  well-
established  practice  at  Union  and  international  level  in  order  to  enhance  legal 
certainty. 

(22)  The rules applicable to medical devices should be aligned, where appropriate, with the 
New  Legislative  Framework  for  the  Marketing  of  Products,  which  consists  of 
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 
2008 setting out the requirements for accreditation and market surveillance relating to 
the marketing of products and repealing Regulation (EEC) No 339/9344 and Decision 
No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a 
common  framework  for  the  marketing  of  products,  and  repealing  Council  Decision 
93/465/EEC45.  

(23)  The  rules  on  Union  market  surveillance  and  control  of  products  entering  the  Union 
market  provided  for  in  Regulation  (EC)  No  765/2008  apply  to  medical  devices  and 
their  accessories  covered  by  this  Regulation  which  does  not  prevent  Member  States 
from choosing the competent authorities to carry out those tasks.  

(24) 

It  is  appropriate  to  set  out  clearly  the  general  obligations  of  the  different  economic 
operators,  including  importers  and  distributors  as  laid  down  in  the  New  Legislative 
Framework for the Marketing of Products, without prejudice to the specific obligations 
laid  down  in  the  different  parts  of  this  Regulation,  to  enhance  understanding  of  the 

42 
43 
44 
45 

OJ L […], […], p. […]. 
OJ L 331, 7.12.1998, p. 1. 
OJ L 218, 13.8.2008, p. 30.  
OJ L 218, 13.8.2008, p. 82. 

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18 

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legal  requirements  and  thus  to  improve  regulatory  compliance  by  the  relevant 
operators. 

(25)  Several  of  the  obligations  on  manufacturers,  such  as  clinical  evaluation  or  vigilance 
reporting,  that  were  set  out  only  in  the  annexes  of  Directives  90/385/EEC  and 
93/42/EEC  should  be  incorporated  into  the  enacting  provisions  of  this  Regulation  to 
enhance legal certainty. 

(26)  To  ensure  that  medical  devices  manufactured  in  series  production  continue  to  be  in 
conformity with the requirements of this Regulation and that experience from the use 
of  their  medical  devices  is  taken  into  account  for  the  production  process,  all 
manufacturers  should  have  a  quality  management  system  and  a  post-market 
surveillance plan in place which should be proportionate to the risk class and the type 
of the medical device.  

(27) 

It  should  be  ensured  that  supervision  and  control  of  the  manufacture  of  medical 
devices  is  carried  out  within  the  manufacturer's  organisation  by  a  person  who  fulfils 
minimum conditions of qualification. 

(28)  For manufacturers who are not established in the Union, the authorised representative 
plays  a  pivotal  role  in  ensuring  the  compliance  of  the  medical  devices  produced  by 
those  manufacturers  and  in  serving  as  their  contact  person  established  in  the  Union. 
The tasks of an authorised representative should be defined in a written mandate with 
the manufacturer which for example may allow the authorised representative to lodge 
an  application  for  a  conformity  assessment  procedure,  to  report  events  under  the 
vigilance  system  or  to  register  devices  placed  on  the  Union  market.  The  mandate 
should  empower  the  authorised  representative  to  duly  fulfil  certain  defined  tasks. 
Considering  the  role  of  authorised  representatives,  the  minimum  requirements  to  be 
met by them should be clearly defined, including the requirement of having available a 
person  who  fulfils  minimum  conditions  of  qualification  which  should  be  similar  to 
those  for  a  manufacturer's  qualified  person  but,  with  a  view  to  the  authorised 
representative's tasks, could also be satisfied by a person with qualification in law. 

(29)  To  ensure  legal  certainty  in  respect  of  the  obligations  incumbent  on  economic 
operators, it is necessary to clarify when a distributor, importer or other person is to be 
considered the manufacturer of a medical device. 

(30)  Parallel trade in products already placed on the market is a lawful form of trade within 
the internal market on the basis of Article 34 TFEU subject to the limitations set by the 
protection  of  health  and  safety  and  by  the  protection  of  intellectual  property  rights 
provided  by  Article  36  TFEU.  Application  of  this  principle  is,  however,  subject  to 
different  interpretations  in  the  Member  States.  The  conditions,  in  particular  the 
requirements  for  relabelling  and  repackaging,  should  therefore  be  specified  in  this 
Regulation,  taking  into  account  the  case-law  of  the  European  Court  of  Justice46  in 
other relevant sectors and existing good practices in the field of medical devices.  

(31)  The  findings  of  the  Scientific  Committee  on  Emerging  and  Newly  Identified  Health 
Risks  (SCENIHR),  established  by  Commission  Decision  2008/721/EC  of  5  August 

46 

Judgment of the Court of 28 July 2011 in joined cases C-400/09 and C-207/10. 

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19 

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2008 setting up an advisory structure of Scientific Committees and experts in the field 
of  consumer  safety,  public  health  and  the  environment  and  repealing  Decision 
2004/210/EC47, in its scientific opinion of 15 April 2010 on the safety of reprocessed 
medical  devices  marketed  for  single-use,  and  of  the  Commission  in  its  report  of  27 
August 2010 to the European Parliament and the Council on the issue of reprocessing 
of medical devices in the European Union, in accordance with Article 12a of Directive 
93/42/EEC48, call for regulation of the reprocessing of single-use devices in order to 
ensure a high level of protection of health and safety whilst allowing this practice to 
further  develop  under  clear  conditions.  By  reprocessing  a  single-use  device  its 
intended  purpose  is  modified  and  the  reprocessor  should  therefore  be  considered  the 
manufacturer of the reprocessed device.  

(32)  Patients who are implanted with a device should be given essential information related 
to  the  implanted  device  allowing  it  to  be  identified  and  containing  any  necessary 
warnings or precautions to be taken, for example indications as to whether or not it is 
compatible with certain diagnostic devices or with scanners used for security controls.  

(33)  Medical  devices  should,  as  a  general  rule,  bear  the  CE  marking  to  indicate  their 
conformity with this Regulation so that they can move freely within the Union and be 
put into service in accordance with their intended purpose. Member States should not 
create  obstacles  to  their  placing  on  the  market  or  putting  into  service  for  reasons 
related to the requirements laid down in this Regulation.  

(34)  The traceability of medical devices by means of a Unique Device Identification (UDI) 
system based on international guidance should significantly enhance the effectiveness 
of  the  post-market  safety  of  medical  devices  due  to  improved  incident  reporting, 
targeted field safety corrective actions and better monitoring by competent authorities. 
It  should  also  help  to  reduce  medical  errors  and  to  fight  against  counterfeit  devices. 
Use  of  the  UDI  system  should  also  improve  purchase-policy  and  stock-management 
by hospitals.  

(35)  Transparency and better information are essential to empower patients and healthcare 
professionals and to enable them to make informed decisions, to provide a sound basis 
for regulatory decision-making and to build confidence in the regulatory system.  

(36)  One  key  aspect  is  the  creation  of  a  central  database  that  should  integrate  different 
electronic  systems,  with  the  UDI  as  an  integral  part  of  it,  to  collate  and  process 
information  regarding  medical  devices  on  the  market  and  the  relevant  economic 
operators,  certificates,  clinical  investigations,  vigilance  and  market  surveillance.  The 
objectives  of  the  database  are  to  enhance  overall  transparency,  to  streamline  and 
facilitate  the  flow  of  information  between  economic  operators,  notified  bodies  or 
sponsors and Member States as well as between Member States among themselves and 
with  the  Commission,  to  avoid  multiple  reporting  requirements  and  to  enhance  the 
coordination between Member States. Within an internal market, this can be ensured 
effectively only at Union level and the Commission should therefore further develop 
and  manage  the  European  databank  on  medical  devices  (Eudamed)  set  up  by 

47 
48 

OJ L 241, 10.9.2008, p. 21. 
COM(2010)443 final. 

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20 

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Commission  Decision 2010/227/EU of 19 April 2010 on the European Databank for 
Medical Devices49.  

(37)  Eudamed's electronic systems regarding devices on the market, the relevant economic 
operators  and  certificates  should  enable  the  public  to  be  adequately  informed  about 
devices on the Union market. The electronic system on clinical investigations should 
serve as tool for the cooperation between Member States and for enabling sponsors to 
submit,  on  a  voluntary  basis,  a  single  application  for  several  Member  States  and,  in 
this case, to report serious adverse events. The electronic system on vigilance should 
enable  manufacturers  to  report  serious  incidents  and  other  reportable  events  and  to 
support  the  coordination  of  their  assessment  by  national  competent  authorities.  The 
electronic system regarding market surveillance should be a tool for the exchange of 
information between competent authorities. 

(38) 

In respect of data collated and processed through the electronic systems of Eudamed, 
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 
on the protection of individuals with regard to the processing of personal data and on 
the free movement of such data50 applies to the processing of personal data carried out 
in  the  Member  States,  under  the  supervision  of  the  Member  States  competent 
authorities, in particular the public independent authorities designated by the Member 
States. Regulation (EC) No 45/2001 of the European Parliament and of the Council of 
18  December  2000  on  the  protection  of  individuals  with  regard  to  the  processing  of 
personal data by the Community institutions and bodies and on the free movement of 
such data51 applies to the processing of personal data carried out by the Commission 
within the framework of this Regulation, under the supervision of the European Data 
Protection  Supervisor.  In  accordance  with  Article  2(d)  of  Regulation  (EC)  No 
45/2001,  the Commission  should be designated  as the controller of  Eudamed and  its 
electronic systems. 

(39)  For  high-risk  medical  devices,  manufacturers  should  summarise  the  main  safety  and 
performance  aspects  of  the  device  and  the  outcome  of  the  clinical  evaluation  in  a 
document that should be publicly available. 

(40)  The proper functioning of notified bodies is crucial for ensuring a high level of health 
and  safety  protection  and  citizens'  confidence  in  the  system.  Designation  and 
monitoring of notified bodies by the Member States, in accordance with detailed and 
strict criteria, should therefore be subject to controls at Union level. 

(41)  The  position  of  notified  bodies  vis-à-vis  manufacturers  should  be  strengthened, 
including  their  right  and  duty  to  carry  out  unannounced  factory  inspections  and  to 
conduct  physical  or  laboratory  tests  on  medical  devices  to  ensure  continuous 
compliance by manufacturers after receipt of the original certification.  

(42)  For high risk medical devices, authorities should be informed at an early stage about 
devices  which  are  subject  to  conformity  assessment  and  be  given  the  right,  on 
scientifically  valid  grounds,  to  scrutinise  the  preliminary  assessment  conducted  by 
notified  bodies,  in  particular  regarding  novel  devices,  devices  for  which  a  novel 

49 
50 
51 

OJ L 102, 23.4.2010, p. 45.  
OJ L 281, 23.11.1995, p. 31. 
OJ L 8, 12.1.2001, p. 1. 

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21 

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technology  is  being  used,  devices  belonging  to  a  category  of  devices  with  increased 
serious incident rates, or devices for which significant discrepancies in the conformity 
assessments  by  different  notified  bodies  have  been  identified  in  respect  of 
substantially similar devices. The process foreseen in this Regulation does not prevent 
a  manufacturer  from  informing  voluntarily  a  competent  authority  of  his  intention  to 
file  an  application  for  conformity  assessment  for  a  high  risk  medical  device  before 
submitting the application to the notified body. 

(43) 

It is necessary, in particular for the purpose of the conformity assessment procedures, 
to  maintain  the  division  of  medical  devices  into  four  product  classes  in  line  with 
international practice. The classification rules, which are based on the vulnerability of 
the  human  body  taking  into  account  the  potential  risks  associated  with  the  technical 
design and manufacture of the devices, need  to be adapted to technical progress and 
experience gained from vigilance and market surveillance. To maintain the same level 
of  safety  as  provided  by  Directive  90/385/EEC,  active  implantable  medical  devices 
and their accessories should be in the highest risk class.  

(44)  The  conformity  assessment  procedure  for  class  I  devices  should  be  carried  out,  as  a 
general rule, under the sole responsibility of the manufacturers in view of the low level 
of vulnerability associated with these products. For medical devices in classes IIa, IIb 
and III, an appropriate level of involvement of a notified body should be compulsory, 
with medical devices in class III requiring explicit prior approval of their design and 
manufacture before they can be placed on the market. 

(45)  The conformity assessment procedures should be simplified and streamlined whilst the 
requirements  for  notified  bodies  as  regards  the  performance  of  their  assessments 
should be clearly specified to ensure a level playing field. 

(46)  To ensure a high level of safety and performance, demonstration of compliance with 
the general safety and performance requirements should be based on clinical data that, 
for class III medical devices and implantable medical devices should, as a general rule, 
be sourced from clinical investigations to be carried out under the responsibility of a 
sponsor  who  can  be  the  manufacturer  or  another  legal  or  natural  person  taking 
responsibility for the clinical investigation. 

(47)  The rules on clinical investigations should be in line with major international guidance 
in  this  field,  such  as  the  international  standard  ISO  14155:2011  on  good  clinical 
practice for clinical investigations of medical devices for human subjects and the most 
recent  (2008)  version  of  the  World  Medical  Association  Declaration  of  Helsinki  on 
Ethical  Principles  for  Medical  Research  Involving  Human  Subjects  to  ensure  that 
clinical investigations conducted in the Union are accepted elsewhere and that clinical 
investigations conducted outside the Union in accordance with international guidelines 
can be accepted under this Regulation. 

(48)  An  electronic  system  should  be  set  up  at  Union  level  to  ensure  that  every  clinical 
investigation is registered in a publicly accessible database. To protect the right to the 
protection  of  personal  data,  recognised  by  Article  8  of  the  Charter  of  Fundamental 
Rights of the European Union, no personal data of subjects participating in a clinical 
investigation should be recorded in the electronic system. To ensure synergies with the 
area  of  clinical  trials  on  medicinal  products,  the  electronic  system  on  clinical 

EN 

22 

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investigations on medical devices should be interoperable with the EU database to be 
set up for clinical trials on medicinal products for human use. 

(49)  Sponsors  of  clinical  investigations  to  be  conducted  in  more  than  one  Member  State 
should  be  given  the  possibility  to  submit  a  single  application  in  order  to  reduce 
administrative burden. In order to allow for resource-sharing and to ensure consistency 
regarding the assessment of the health and safety related aspects of the investigational 
device  and  of  the  scientific  design  of  the  clinical  investigation  to  be  conducted  in 
several  Member  Stats,  such  single  application  should  facilitate  the  coordination 
between the Member States under the direction of a coordinating Member State. The 
coordinated  assessment  should  not  include  the  assessment  of  intrinsically  national, 
local and ethical aspects of a clinical investigation, including informed consent. Each 
Member  State  should  retain  the  ultimate  responsibility  for  deciding  whether  the 
clinical investigation may be conducted on its territory. 

(50)  Sponsors should report certain adverse events occurring during clinical investigations 
to  the  Member  States  concerned,  which  should  have  the  possibility  to  terminate  or 
suspend the investigations if considered necessary to ensure a high level of protection 
of  the  subjects  enrolled  in  a  clinical  investigation.  Such  information  should  be 
communicated to the other Member States. 

(51)  This  Regulation  should  only  cover  clinical  investigations  which  pursue  regulatory 

purposes laid down in this Regulation. 

(52) 

In  order  to  better  protect  health  and  safety  regarding  devices  on  the  market,  the 
vigilance  system  for  medical  devices  should  be  made  more  effective  by  creating  a 
central portal at Union level for reporting serious incidents and field safety corrective 
actions. 

(53)  Healthcare professionals and patients should be empowered to report suspected serious 
incidents  at  national  level  using  harmonised  formats.  The  national  competent 
authorities  should  inform  manufacturers  and  share  the  information  with  their  peers 
when they confirm that a serious incident has occurred in order to minimise recurrence 
of those incidents. 

(54)  The assessment of reported serious incidents and field safety corrective actions should 
be  conducted  at  national  level  but  coordination  should  be  ensured  where  similar 
incidents  have  occurred  or  field  safety  corrective  actions  have  to  be  carried  out  in 
more  than  one  Member  State  with  the  objective  of  sharing  resources  and  ensuring 
consistency regarding the corrective action. 

(55)  The reporting of serious adverse events during clinical investigations and the reporting 
of  serious  incidents  occurring  after  a  medical  device  has  been  placed  on  the  market 
should be clearly distinguished to avoid double reporting. 

(56)  Rules  on  market  surveillance  should  be  included  in  this  Regulation  to  reinforce  the 
rights  and  obligations  of  the  national  competent  authorities,  to  ensure  effective 
coordination  of  their  market  surveillance  activities  and  to  clarify  the  applicable 
procedures.  

EN 

23 

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(57)  The  Member  States  shall  levy  fees  for  the  designation  and  monitoring  of  notified 
bodies  to  ensure  sustainability  of  the  monitoring  of  those  bodies  by  Member  States 
and to establish a level playing field for notified bodies.  

(58)  Whilst  this  Regulation  should  not  affect  the  right  of  Member  States  to  levy  fees  for 
activities  at  national  level,  Member  States  should  inform  the  Commission  and  the 
other  Member  States  before  they  adopt  the  level  and  structure  of  the  fees  to  ensure 
transparency. 

(59)  An expert committee, the Medical Device Coordination Group (MDCG), composed of 
persons designated by the Member States based on their role and expertise in the field 
of  medical  devices  and  in  vitro  diagnostic  medical  devices  should  be  established  to 
fulfil the tasks conferred on it by this Regulation and by Regulation (EU) […/…] on in 
vitro diagnostic medical devices52, to provide advice to the Commission and to assist 
the Commission and the Member States in ensuring a harmonised implementation of 
this Regulation. 

(60)  Closer  coordination  between  national  competent  authorities  through  information 
exchange and coordinated assessments under the direction of a coordinating authority 
is  fundamental  for  ensuring  a  consistently  high  level  of  health  and  safety  within  the 
internal market, in particular in the areas of clinical investigations and vigilance. This 
should also lead to more efficient use of scarce resources at national level. 

(61)  The  Commission  should  provide  scientific,  technical  and  corresponding  logistic 
support to the coordinating national authority and ensure that the regulatory system for 
medical  devices  is  effectively  implemented  at  Union  level  based  on  sound  scientific 
evidence. 

(62)  The  Union  should  actively  participate  in  international  regulatory  cooperation  in  the 
field  of  medical  devices  to  facilitate  the  exchange  of  safety-related  information 
regarding  medical  devices  and  to  foster  the  further  development  of  international 
regulatory guidelines promoting the adoption of regulations in other jurisdictions with 
a level of health and safety protection equivalent to that set by this Regulation.  

(63)  This Regulation respects the fundamental rights and observes the principles recognised 
in particular by the Charter of Fundamental Rights of the European Union and notably 
human dignity, the integrity of the person, the protection of personal data, the freedom 
of  art  and  science,  the  freedom  to  conduct  business  and  the  right  to  property.  This 
Regulation  should  be  applied  by  the  Member  States  in  accordance  with  those  rights 
and principles. 

(64) 

In  order  to  maintain  a  high  level  of  health  and  safety,  the  power  to  adopt  acts  in 
accordance with Article 290 TFEU should be delegated to the Commission in respect 
of the products subject to this Regulation that are similar to medical devices but do not 
necessarily  have  a  medical  purpose;  adaptation  of  the  definition  of  nanomaterial  to 
technical progress and to developments at Union and international level; adaptation to 
technical progress of the general safety and performance requirements, of the elements 
to  be  addressed  in  the  technical  documentation,  of  the  minimum  content  of  the  EU 

52 

OJ L […], […], p. […]. 

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24 

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declaration  of  conformity  and  of  the  certificates  issued  by  notified  bodies,  of  the 
minimum requirements to be met by notified bodies, of the classification rules, of the 
conformity assessment procedures, and of  the documentation to be submitted for the 
approval  of  clinical  investigations;  the  establishment  of  the  UDI  system;  the 
information  to  be  submitted  for  the  registration  of  medical  devices  and  certain 
economic operators; the level and structure of fees for the designation and monitoring 
of  notified  bodies;  the  publicly  available  information  in  respect  of  clinical 
investigations; the adoption of preventive health protection measures at EU level; and 
the tasks of and criteria for European Union  reference laboratories and the level  and 
structure of fees for scientific opinions delivered by them.  

It is of particular importance that the Commission carry out appropriate consultations 
during  its  preparatory  work,  including  at  expert  level.  The  Commission,  when 
preparing  and  drawing  up  delegated  acts,  should  ensure  a  simultaneous,  timely  and 
appropriate transmission of relevant documents to the European Parliament and to the 
Council. 

(65) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing powers should be conferred on the Commission. Those powers should 
be  exercised  in  accordance  with  Regulation  (EU)  No  182/2011  of  the  European 
Parliament and of the Council of 16 February 2011 laying down the rules and general 
principles concerning mechanisms for control by Member States of the Commission's 
exercise of implementing powers53.  

(66)  The advisory procedure should be used for the adoption of the form and presentation 
of  the  data  elements  of  the  manufacturers'  summary  of  safety  and  clinical 
performance; of the codes defining the notified bodies' scopes of designation; and of 
the model for certificates of free sale, given that those acts have a procedural character 
and do not directly impact the health and safety at Union level. 

(67)  The  Commission  should  adopt  immediately  applicable  implementing  acts  where,  in 
duly justified cases relating to the extension to the territory of the Union of a national 
derogation from the applicable conformity assessment procedures in exceptional cases; 
relating to the Commission's position whether a provisional national measure against a 
medical device presenting a risk or a provisional national preventive health protection 
measure is justified or not; and relating to the adoption of a Union measure against a 
medical device presenting a risk, imperative grounds of urgency so require.  

(68)  To allow economic operators, notified bodies, Member States and the Commission to 
adapt to the changes introduced by this Regulation, it is  appropriate to provide for a 
sufficient 
the  organisational 
arrangements to be taken for its proper application. It is particularly important that by 
the  date  of  application,  a  sufficient  number  of  notified  bodies  are  designated  in 
accordance with the new requirements to avoid any shortage of medical devices on the 
market. 

that  adaptation  and  for 

transitional  period  for 

(69) 

In  order  to  ensure  a  smooth  transition  to  the  registration  of  medical  devices,  of 
relevant  economic  operators  and  of  certificates,  the  obligation  to  submit  the  relevant 

53 

OJ L 55, 28.2.2011, p. 13.  

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25 

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information  to  the  electronic  systems  put  in  place  by  this  Regulation  at  Union  level 
should  become  fully  effective  only  18  months  after  the  date  of  application  of  this 
Regulation. During this transitional period, Article 10a and point (a) of Article 10b(1) 
of  Directive  90/385/EEC  and  Article  14(1)  and  (2)  and  points  (a)  and  (b)  of  Article 
14a(1) of Directive 93/42/EEC should remain in force. However, economic operators 
and  notified  bodies  who  register  in  the  relevant  electronic  systems  provided  for  at 
Union  level  should  be  considered  in  compliance  with  the  registration  requirements 
adopted by the Member States pursuant to those provisions of the Directives to avoid 
multiple registrations.  

(70)  Directives 90/385/EEC and 93/42/EEC should be repealed to ensure that only one set 
of rules applies to the placing of medical devices on the market and the related aspects 
covered by this Regulation.  

(71)  Since the objective of this Regulation, namely to ensure high standards of quality and 
safety for medical devices, thus ensuring a high level of protection of health and safety 
of  patients,  users  and  other  persons,  cannot  sufficiently  be  achieved  by  the  Member 
States  and  can,  by  reason  of  the  scale  of  the  measure,  be  better  achieved  at  Union 
level, the Union may adopt measures, in accordance with the principle of subsidiarity 
as  set  out  in  Article  5  of  the  Treaty  on  European  Union.  In  accordance  with  the 
principle  of  proportionality,  as  set  out  in  that  Article,  this  Regulation  does  not  go 
beyond what is necessary in order to achieve that objective. 

HAVE ADOPTED THIS REGULATION: 

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Chapter I 
Scope and definitions 

Article 1 
Scope 

1. 

This  Regulation  establishes  rules  to  be  complied  with  by  medical  devices  and 
accessories to medical devices that are placed on the market or put into service in the 
Union for human use. 

For  the  purposes  of  this  Regulation,  medical  devices  and  accessories  to  medical 
devices shall hereinafter be referred to as ‘devices’. 

2. 

This Regulation shall not apply to:  

(a) 

in vitro diagnostic medical devices covered by Regulation (EU) […/…]; 

(b)  medicinal  products  covered  by  Directive  2001/83/EC  and  advanced  therapy 
medicinal  products  covered  by  Regulation  (EC)  No  1394/2007.  In  deciding 
whether  a  product  falls  under  Directive  2001/83/EC  or  Regulation  (EC)  No 
1394/2007  or  under  this  Regulation,  particular  account  shall  be  taken  of  the 
principal mode of action of the product; 

(c)  human blood, blood products, plasma or blood cells of human origin or devices 
which incorporate, when placed on the market or used in accordance with the 
manufacturer's  instructions,  such  blood  products,  plasma  or  cells,  except  for 
devices referred to in paragraph 4; 

(d) 

cosmetic products covered by Regulation (EC) No 1223/2009; 

(e) 

transplants,  tissues  or  cells  of  human  or  animal  origin  or  their  derivatives,  or 
products  containing  or  consisting  of  them,  unless  a  device  is  manufactured 
utilising tissues or cells of human or animal origin, or their derivatives, which 
are non-viable or are rendered non-viable. 

However,  human  tissues  and  cells  that  are  non-viable  or  are  rendered  non-
viable and that have undergone only non-substantial manipulation, in particular 
those listed in Annex I of Regulation (EC) No 1394/2007, and products derived 
from  such  tissues  and  cells,  shall  not  be  considered  devices  manufactured 
utilising tissues or cells of human origin or their derivatives;  

(f) 

products  that  contain  or  consist  of  biological  substances  or  organisms  other 
than  those  referred  to  in  points  (c)  and  (e)  that  are  viable,  including  living 
micro-organisms, bacteria, fungi or virus; 

(g) 

food covered by Regulation (EC) No 178/2002.  

3. 

Any  device  which,  when  placed  on  the  market  or  used  in  accordance  with  the 
manufacturer's  instructions,  incorporates  as  an  integral  part  an  in  vitro  diagnostic 

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27 

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medical  device  as  defined  in  Article  2  of  Regulation  (EU)  […/...]  [on  in  vitro 
diagnostic medical devices] shall be governed by this Regulation, unless it is covered 
by  Article  1(3)  of  that  Regulation.  The  relevant  general  safety  and  performance 
requirements set out in Annex I of that Regulation shall apply as far as the safety and 
performance of the in vitro diagnostic medical device part are concerned.  

Where  a  device,  when  placed  on  the  market  or  used  in  accordance  with  the 
manufacturer's  instructions,  incorporates,  as  an  integral  part,  a  substance  which,  if 
used separately, would be considered to be a medicinal product as defined in Article 
1(2)  of  Directive  2001/83/EC,  including  a  medicinal  product  derived  from  human 
blood  or  human  plasma  as  defined  in  Article  1(10)  of  that  Directive,  with  action 
ancillary  to  that  of  the  device,  that  device  shall be  assessed  and  authorised  in 
accordance with this Regulation. 

However,  if  the  action  of  the  medicinal  substance  is  not  ancillary  to  that  of  the 
device,  the  product  shall  be  governed  by  Directive  2001/83/EC.  In  this  case,  the 
relevant  general  safety  and  performance  requirements  set  out  in  Annex  I  of  this 
Regulation  shall  apply  as  far  as  the  safety  and  performance  of  the  device  part  are 
concerned. 

Where  a  device  is  intended  to  administer a  medicinal  product  as  defined  in  Article 
1(2)  of  Directive  2001/83/EC,  that  device  shall  be  governed  by  this  Regulation, 
without  prejudice  to  the  provisions  of  Directive  2001/83/EC  with  regard  to  the 
medicinal product.  

However, if the device intended to administer a medicinal product and the medicinal 
product  are  placed  on  the  market  in  such  a  way  that  they  form  a  single  integral 
product which is intended exclusively for use in the given combination and which is 
not reusable, the product shall be governed by Directive 2001/83/EC. In this case, the 
relevant  general  safety  and  performance  requirements  set  out  in  Annex  I  of  this 
Regulation  shall  apply  as  far  as  the  safety  and  performance  of  the  device  part  are 
concerned. 

This Regulation is a specific Union legislation within the meaning of Article 1(4) of 
Directive 2004/108/EC and within the meaning of Article 3 of Directive 2006/42/EC. 

This Regulation shall not affect the application of Council Directive 96/29/Euratom 
nor of Council Directive 97/43/Euratom. 

This Regulation shall not affect national laws which require that certain devices may 
only be supplied on a medical prescription. 

References to a Member State in this Regulation shall be understood as including any 
other  country  with  which  the  Union  has  concluded  an  agreement  which  confers  on 
that country the same status as a Member State for the purpose of application of this 
Regulation. 

4. 

5. 

6. 

7. 

8. 

9. 

1. 

For the purposes of this Regulation, the following definitions shall apply: 

Article 2 
Definitions 

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Definitions related to devices: 

(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 specific 
medical purposes of:  

– 

– 

– 

– 

– 

diagnosis,  prevention,  monitoring,  treatment  or  alleviation  of 
disease, 

diagnosis, monitoring, treatment, alleviation of or compensation for 
an injury or disability, 

investigation,  replacement  or  modification  of  the  anatomy  or  of  a 
physiological process or state, 

control or support of conception, 

disinfection  or  sterilisation  of  any  of 
products,  

the  above-mentioned 

(2) 

(3) 

and  which  does  not  achieve  its  principal  intended  action  by  pharmacological, 
immunological or metabolic means, in or on the human body, but which may 
be assisted in its function by such means. 

The  implantable  or  other  invasive  products,  intended  to  be  used  for  human 
beings,  which  are  listed  in  Annex  XV  shall  be  considered  medical  devices, 
regardless of whether or not they are intended by the manufacturer to be used 
for a medical purpose. 

‘accessory  to  a  medical  device’  means  an  article  which,  whilst  not  being  a 
medical device, is intended by its manufacturer to be used together with one or 
several particular medical device(s) to specifically enable or assist the device(s) 
to be used in accordance with its/their intended purpose(s); 

‘custom-made device’ means any device specifically made in accordance with 
a written prescription of a doctor of medicine, of a dental practitioner or of any 
other person authorised by national law by virtue of this person's professional 
responsibility,  specific  design 
qualifications  which  gives,  under  his 
characteristics, and is intended for the sole use of a particular patient. 

 However,  mass-produced  devices  which  need  to  be  adapted  to  meet  the 
specific requirements of a doctor of medicine, a dental practitioner or any other 
professional user and devices which are mass-produced by means of industrial 
manufacturing  processes  in  accordance  with  the  written  prescriptions  of 
doctors  of  medicine,  dental  practitioners  or  any  other  authorised  person  shall 
not be considered to be custom-made devices; 

(4) 

‘active device’ means any device, the operation of which depends on a source 
of  electrical  energy  or  any  source  of  power  other  than  that  directly  generated 
by gravity and which acts by changing the density of or converting this energy. 
Devices intended to transmit energy, substances or other elements between an 

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29 

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active  device  and  the  patient,  without  any  significant  change,  shall  not  be 
considered to be active devices.  

 Stand alone software shall be considered an active device; 

(5) 

‘implantable  device’  means  any  device,  including  those  that  are  partially  or 
wholly absorbed, which is intended  

– 

– 

to be totally introduced into the human body or 

to replace an epithelial surface or the surface of the eye,  

 by  clinical  intervention  and  which  is  intended  to  remain  in  place  after  the 
procedure.  

 Any device intended to be partially introduced into the human body by clinical 
intervention and intended to remain in place after the procedure for at least 30 
days shall also be considered an implantable device; 

(6) 

(7) 

‘invasive  device’  means  any  device  which,  in  whole  or  in  part,  penetrates 
inside  the  body,  either  through  a  body  orifice  or  through  the  surface  of  the 
body; 

‘generic  device  group’  means  a  set  of  devices  having  the  same  or  similar 
intended purposes or commonality of technology allowing them to be classified 
in a generic manner not reflecting specific characteristics;  

(8) 

‘single-use device’ means a device that is intended to be used on an individual 
patient during a single procedure. 

The single procedure may involve several uses or prolonged use on the same 
patient;  

(9) 

‘single-use  device  for  critical  use’  means  a  single-use  device  intended  to  be 
used for surgically invasive medical procedures; 

(10)  ‘intended purpose’ means the use for which the device is intended according to 
the data supplied by the manufacturer on the label, in the instructions for use or 
in promotional or sales materials or statements; 

(11)  ‘label’  means  the  written,  printed,  or  graphic  information  appearing  either  on 
the  device  itself,  or  on  the  packaging  of  each  unit  or  on  the  packaging  of 
multiple devices; 

(12)  ‘instructions  for  use’  means  the  information  provided  by  the  manufacturer  to 
inform  the  user  of  the  device’s  intended  purpose  and  proper  use  and  of  any 
precautions to be taken; 

(13)  ‘Unique  Device  Identification’  (‘UDI’)  means  a  series  of  numeric  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; 

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30 

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(14)  ‘non-viable’ means having no potential for metabolism or multiplication; 

(15)  ‘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 
range  
1-100 nm.  

dimensions 

external 

size 

the 

in 

is 

 Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more 
external dimensions below 1 nm shall be considered as nanomaterials.  

 For  the  purposes  of  the  definition  of  nanomaterial,  ‘particle’,  ‘agglomerate’ 
and ‘aggregate’ are defined as follows:  

– 

– 

– 

‘particle’  means  a  minute  piece  of  matter  with  defined  physical 
boundaries;  

‘agglomerate’  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;  

‘aggregate’ means a particle comprising of strongly bound or fused 
particles;  

Definitions related to the making available of devices: 

(16)  ‘making available on the market’ means any supply of a device, other than an 
investigational  device,  for  distribution,  consumption  or  use  on  the  Union 
market in the course of a commercial activity, whether in return for payment or 
free of charge;  

(17)  ‘placing on the market’ means the first making available of a device, other than 

an investigational device, on the Union market; 

(18)  ‘putting  into  service’  means  the  stage  at  which  a  device,  other  than  an 
investigational device, has been made available to the final user as being ready 
for use on the Union market for the first time for its intended purpose;  

Definitions related to economic operators, users and specific processes: 

(19)  ‘manufacturer’  means  the  natural  or  legal  person  who  manufactures  or  fully 
refurbishes  a  device  or  has  a  device  designed,  manufactured  or  fully 
refurbished, and markets that device under his name or trademark. 

For the purposes of the definition of manufacturer, fully refurbishing is defined 
as the complete rebuilding of a device already placed on the market or put into 
service,  or  the  making  of  a  new  device  from  used  devices,  to  bring  it  in 
conformity  with  this  Regulation,  combined  with  the  assignment  of  a  new 
lifetime to the refurbished device; 

(20)  ‘authorised  representative’  means  any  natural  or  legal  person  established 
within  the  Union  who  has  received  and  accepted  a  written  mandate  from  a 

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31 

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manufacturer  to  act  on  his  behalf  in  relation  to  specified  tasks  with  regard  to 
the latter's obligations under this Regulation; 

(21)  ‘importer’ means any natural or legal person established within the Union who 

places a device from a third country on the Union market; 

(22)  ‘distributor’ means any natural or legal person in the supply chain, other than 
the manufacturer or the importer, who makes a device available on the market; 

(23)  ‘economic  operators’  means  the  manufacturer,  the  authorised  representative, 

the importer and the distributor;  

(24)  ‘health institution’ means an organisation whose primary purpose is the care or 

treatment of patients or the promotion of public health; 

(25)  ‘user’ means any healthcare professional or lay person who uses a device; 

(26)  ‘lay  person’  means  an  individual  who  does  not  have  formal  education  in  a 

relevant field of healthcare or medical discipline;  

(27)  ‘reprocessing’ means the process carried out on a used device in order to allow 
its  safe  reuse  including  cleaning,  disinfection,  sterilisation  and  related 
procedures,  as  well  as  testing  and  restoration  of  the  technical  and  functional 
safety of the used device;  

Definitions related to conformity assessment: 

(28)  ‘conformity  assessment’  means  the  process  demonstrating  whether  the 
requirements of this Regulation relating to a device have been fulfilled;  

(29)  ‘conformity  assessment  body’  means  a  body  that  performs  third-party 
conformity assessment activities including calibration, testing, certification and 
inspection;  

(30)  ‘notified body’ means a conformity assessment body designated in accordance 

with this Regulation;  

(31)  ‘CE  marking  of  conformity’  or  ‘CE  marking’  means  a  marking  by  which  the 
manufacturer  indicates  that  the  device  is  in  conformity  with  the  applicable 
this  Regulation  and  other  applicable  Union 
in 
requirements  set  out 
harmonisation legislation providing for its affixing; 

Definitions related to clinical evaluation and clinical investigations: 

(32)  ‘clinical  evaluation’  means  the  assessment  and  analysis  of  clinical  data 
pertaining  to  a  device  in  order  to  verify  the  safety  and  performance  of  the 
device when used as intended by the manufacturer; 

(33)  ‘clinical  investigation’  means  any  systematic  investigation  in  one  or  more 
human subjects, undertaken to assess the safety or performance of a device; 

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32 

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(34)  ‘investigational  device’  means  any  device  being  assessed  for  safety  and/or 

performance in a clinical investigation;  

(35)  ‘clinical  investigation  plan’  means  the  document(s)  setting  out  the  rationale, 
objectives,  design  and  proposed  analysis,  methodology,  monitoring,  conduct 
and record-keeping of the clinical investigation; 

(36)  ‘clinical data’ means the information concerning the safety or performance that 

is generated from the use of a device and that are sourced from the following: 

– 

– 

– 

clinical investigation(s) of the device concerned,  

clinical  investigation(s)  or  other  studies  reported  in  the  scientific 
literature, of a similar device for which equivalence to the device in 
question can be demonstrated,  

published  and/or  unpublished  reports  on  other  clinical  experience 
of  either  the  device  in  question  or  a  similar  device  for  which 
equivalence to the device in question can be demonstrated; 

(37)  ‘sponsor’  means  an  individual,  company,  institution  or  organisation  which 
initiation  and  management  of  a  clinical 

the 

takes  responsibility  for 
investigation; 

(38)  ‘adverse event’ means any untoward medical occurrence, unintended disease or 
injury  or  any  untoward  clinical  signs,  including  an  abnormal  laboratory 
finding,  in  subjects,  users  or  other  persons,  in  the  context  of  a  clinical 
investigation, whether or not related to the investigational device; 

(39)  ‘serious  adverse  event’  means  any  adverse  event  that  led  to  any  of  the 

following: 

– 

– 

death, 

serious deterioration in the health of the subject, that resulted in any 
of the following: 

(i) 

life-threatening illness or injury, 

(ii)  permanent impairment of a body structure or a body function,  

(iii)  hospitalisation or extending the duration of hospitalisation,  

(iv)  medical  or  surgical  intervention  to  prevent  life-threatening 
illness or injury or permanent impairment to a body structure 
or a body function, 

– 

foetal  distress,  foetal  death  or  a  congenital  abnormality  or  birth 
defect; 

(40)  ‘device  deficiency’  means  any  inadequacy  in  the  identity,  quality,  durability, 
reliability,  safety  or  performance  of  an  investigational  device,  including 

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33 

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malfunction,  use  errors  or  inadequacy  in  the  information  supplied  by  the 
manufacturer;  

Definitions related to vigilance and market surveillance: 

(41)  ‘recall’ means any measure aimed at achieving the return of a device that has 

already been made available to the end user;  

(42)  ‘withdrawal’  means  any  measure  aimed  at  preventing  a  device  in  the  supply 

chain from further being made available on the market; 

(43)  ‘incident’  means  any  malfunction  or  deterioration  in  the  characteristics  or 
performance of a device made available on the market, any inadequacy in the 
information  supplied  by  the  manufacturer  and  any  unexpected  undesirable 
side-effect; 

(44)  ‘serious incident’ means any incident that directly or indirectly led, might have 

led or might lead to any of the following: 

– 

– 

death of a patient, user or other person,  

temporary or permanent serious deterioration of the patient's, user's 
or other person's state of health,  

– 

serious public health threat; 

(45)  ‘corrective action’ means action taken to eliminate the cause of a potential or 

real non-conformity or other undesirable situation; 

(46)  ‘field  safety  corrective  action’  means  corrective  action  taken  by  the 
manufacturer for technical or medical reasons to prevent or reduce the risk of a 
serious incident in relation to a device made available on the market; 

(47)  ‘field  safety  notice’  means  the  communication  sent  by  the  manufacturer  to 

users or customers in relation to a field safety corrective action; 

(48)  ‘market  surveillance’  means  the  activities  carried  out  and  measures  taken  by 
public authorities to ensure that products 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; 

Definitions related to standards and other technical specifications: 

(49)  ‘harmonised standard’ means a European standard as defined in Article 2(1)(c) 

of Regulation (EU) No […/…]; 

(50)  ‘common technical specifications’ means a document other than a standard that 
prescribes  technical  requirements  that  provide  a  means  to  comply  with  the 
legal obligation applicable to a device, process or system. 

2. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  89  to  amend  the  list  in  Annex  XV  referred  to  in  the  last  subparagraph  of 

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34 

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3. 

1. 

2. 

number (1) of paragraph 1, in the light of technical progress and taking into account 
the similarity between a medical device and a product without a medical purpose in 
respect of their characteristics and risks. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 89 in order to adapt the definition of nanomaterial set out in number (15) of 
paragraph  1  in  view  of  technical  and  scientific  progress  and  taking  into  account 
definitions agreed at Union and international level. 

Article 3 
Regulatory status of products 

The Commission may, at the request of a Member State or on its own initiative, by 
means of implementing acts, determine whether or not a specific product, or category 
or group of products, falls within the definitions of 'medical device' or 'accessory to a 
medical  device'.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 88(3). 

The Commission shall ensure the sharing of expertise between Member States in the 
fields  of  medical  devices,  in  vitro  diagnostic  medical  devices,  medicinal  products, 
human tissues and cells, cosmetics, biocides, food and, if necessary, other products in 
order  to  determine  the  appropriate  regulatory  status  of  a  product,  or  category  or 
group of products.  

Chapter II 
Making available of devices, obligations of economic operators, 
reprocessing, CE marking, free movement 

Article 4 
Placing on the market and putting into service 

1. 

2. 

3. 

4. 

A device may be placed on the market or put into service only if it complies with this 
Regulation  when  duly  supplied  and  properly  installed,  maintained  and  used  in 
accordance with its intended purpose.  

A device shall meet the general safety and performance requirements which apply to 
it,  taking  into  account  its  intended  purpose.  General  safety  and  performance 
requirements are set out in Annex I. 

Demonstration of conformity with the general safety and performance requirements 
shall include a clinical evaluation in accordance with Article 49.  

Devices  that  are  manufactured  and  used  within  a  single  health  institution  shall  be 
considered as being put into service. The provisions regarding CE marking referred 
to in Article 18 and the obligations laid down in Articles 23 to 27 shall not apply to 
those  devices,  provided  that  manufacture  and  use  of  those  devices  occur  under  the 
health institution's single quality management system. 

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35 

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5. 

1. 

2. 

1. 

2. 

1. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  89  amending  or  supplementing,  in  the  light  of  technical  progress  and 
considering  the  intended  users  or  patients,  the  general  safety  and  performance 
requirements  set  out  in  Annex  I,  including  the  information  supplied  by  the 
manufacturer. 

Article 5 
Distance sales  

A device offered by means of information society services as defined in Article 1(2) 
of  Directive  98/34/EC  to  a  natural  or  legal  person  established  in  the  Union  shall 
comply with this Regulation at the latest when the device is placed on the market.  

Without  prejudice  to  national  legislation  regarding  the  exercise  of  the  medical 
profession,  a  device  that  is  not  placed  on  the  market  but  used  in  the  context  of  a 
commercial  activity  for  the  provision  of  a  diagnostic  or  therapeutic  service  offered 
by  means  of  information  society  services  as  defined  in  Article  1(2)  of  Directive 
98/34/EC  or  by  other  means  of  communication  to  a  natural  or  legal  person 
established in the Union shall comply with this Regulation.  

Article 6 
Harmonised standards 

Devices  which  are  in  conformity  with  the  relevant  harmonised  standards,  or  parts 
thereof,  the  references  of  which  have  been  published  in  the  Official  Journal  of  the 
European Union shall be presumed to be in conformity with the requirements of this 
Regulation covered by those standards or parts thereof.  

The  first  subparagraph  shall  also  apply  to  system  or  process  requirements  to  be 
fulfilled  by  economic  operators  or  sponsors  in  accordance  with  this  Regulation, 
including  those  related  to  the  quality  management  system,  risk  management,  the 
post-market  surveillance  plan,  clinical  investigations,  clinical  evaluation  or  post-
market clinical follow-up.  

Reference  to  harmonised  standards  also  includes  the  monographs  of  the  European 
Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a 
European  Pharmacopoeia,  notably  on  surgical  sutures  and  on  interaction  between 
medicinal  products  and  materials  used  in  devices  containing  such  medicinal 
products. 

Article 7 
Common technical specifications 

Where no harmonised standards exist or where relevant harmonised standards are not 
sufficient,  the  Commission  shall  be  empowered  to  adopt  common  technical 
specifications  (CTS)  in  respect  of  the  general  safety  and  performance  requirements 
set  out  in  Annex  I,  the  technical  documentation  set  out  in  Annex  II  or  the  clinical 
evaluation and post-market clinical follow-up set out in Annex XIII. The CTS shall 

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36 

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2. 

3. 

1. 

2. 

3. 

4. 

5. 

be  adopted  by  means  of  implementing  acts  in  accordance  with  the  examination 
procedure referred to in Article 88(3). 

Devices  which  are  in  conformity  with  the  CTS  referred  to  in  paragraph  1  shall  be 
presumed  to  be  in  conformity  with  the  requirements  of  this  Regulation  covered  by 
those CTS or parts thereof. 

Manufacturers shall comply with the CTS unless they can duly justify that they have 
adopted  solutions  ensuring  a  level  of  safety  and  performance  that  is  at  least 
equivalent thereto. 

Article 8 
General obligations of the manufacturer 

When placing their devices on the market or putting them into service, manufacturers 
shall ensure that they have been designed and manufactured in accordance with the 
requirements of this Regulation. 

Manufacturers  shall  draw  up  the  technical  documentation  which  shall  allow 
assessment of the conformity of the device with the requirements of this Regulation. 
The technical documentation shall include the elements set out in Annex II.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  89  amending  or  supplementing,  in  the  light  of  technical  progress,  the 
elements in the technical documentation set out in Annex II. 

following 

Where  compliance  of  a  device  with  the  applicable  requirements  has  been 
demonstrated 
the  applicable  conformity  assessment  procedure, 
manufacturers  of  devices,  other  than  custom-made  or  investigational  devices,  shall 
draw up an EU declaration of conformity in accordance with Article 17 and affix the 
CE marking of conformity in accordance with Article 18. 

Manufacturers  shall  keep  the  technical  documentation,  the  EU  declaration  of 
conformity  and,  if  applicable,  a  copy  of  the  relevant  certificate  including  any 
supplement,  issued  in  accordance  with  Article  45,  available  to  the  competent 
authorities  for  a  period  of  at  least  five  years  after  the  last  device  covered  by  the 
declaration of conformity has been placed on the market. In the case of implantable 
devices, the period shall be at least 15 years after the last device has been placed on 
the market. 

Where the technical documentation is voluminous or held in different locations, the 
manufacturer  shall  provide,  upon  request  by  a  competent  authority,  a  summary 
technical documentation (STED) and grant access to the full technical documentation 
upon request. 

Manufacturers shall ensure that procedures are in place to keep series production in 
conformity  with  the  requirements  of  this  Regulation.  Changes  in  product  design  or 
characteristics  and  changes  in  the  harmonised  standards  or  CTS  by  reference  to 
which  conformity  of  a  product  is  declared  shall  be  adequately  taken  into  account. 
Proportionate to the risk class and the type of device, manufacturers of devices, other 

EN 

37 

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than  custom-made  or  investigational  devices,  shall  institute  and  keep  up  to  date  a 
quality management system that shall address at least the following aspects:  

(a) 

the responsibility of the management;  

(b) 

resource  management,  including  selection  and  control  of  suppliers  and  sub-
contractors; 

(c)  product realisation;  

(d)  processes for monitoring and measurement of output, data analysis and product 

improvement.  

Proportionate to the risk class and the type of device, manufacturers of devices, other 
than custom-made devices, shall institute and keep up to date a systematic procedure 
to collect and review experience gained from their devices placed on the market or 
put into service and to apply any necessary corrective action, hereinafter referred to 
as ‘post-market surveillance plan’. The post-market surveillance plan shall set out the 
process  for  collecting,  recording  and  investigating  complaints  and  reports  from 
healthcare professionals, patients or users on suspected incidents related to a device, 
keeping  a  register  of  non-conforming  products  and  product  recalls  or  withdrawals, 
and if deemed appropriate due to the nature of the device, sample testing of marketed 
devices.  Part  of  the  post-market  surveillance  plan  shall  be  a  plan  for  post-market 
clinical  follow-up  in  accordance  with  Part  B  of  Annex  XIII.  Where  post-market 
clinical  follow-up  is  not  deemed  necessary,  this  shall  be  duly  justified  and 
documented in the post-market surveillance plan. 

If  in  the  course  of  the  post-market  surveillance  a  need  for  corrective  action  is 
identified, the manufacturer shall implement the appropriate measures. 

Manufacturers shall ensure that the device is accompanied by the information to be 
supplied  in  accordance  with  Section  19  of  Annex  I  in  an  official  Union  language 
which can  be easily understood by the intended user or patient.  The language(s) of 
the information to be supplied by the manufacturer may be determined by the law of 
the Member State where the device is made available to the user or patient. 

Manufacturers who consider or have reason to believe that a device which they have 
placed on the market is not in conformity with this Regulation shall immediately take 
the necessary corrective action to bring that product into conformity, withdraw it or 
recall it, as appropriate. They shall inform the distributors and, where applicable, the 
authorised representative accordingly.  

Manufacturers  shall,  in  response  to  a  reasoned  request  from  a  competent  authority, 
provide it with all the information and documentation necessary to demonstrate the 
conformity  of  the  device,  in  an  official  Union  language  which  can  be  easily 
understood by that authority. They shall cooperate with that authority, at its request, 
on  any  corrective  action  taken  to  eliminate  the  risks  posed  by  devices  which  they 
have placed on the market or put into service.  

6. 

7. 

8. 

9. 

10. 

Where manufacturers have their devices designed and manufactured by another legal 
or  natural  person  the  information  on  the  identity  of  that  person  shall  be  part  of  the 
information to be submitted in accordance with Article 25.  

EN 

38 

   EN 

 
1. 

2. 

3. 

4. 

5. 

Article 9 
Authorised representative 

A  manufacturer  of  a  device  that  is  placed  on  the  Union  market,  or  bears  the  CE 
marking without being placed on the Union market, who does not have a registered 
place  of  business  in  a  Member  State  or  does  not  carry  out  relevant  activities  at  a 
registered  place  of  business  in  a  Member  State,  shall  designate  a  single  authorised 
representative.  

The  designation  shall  be  valid  only  when  accepted  in  writing  by  the  authorised 
representative and shall be effective at least for all devices of the same generic device 
group.  

The authorised representative shall perform the tasks specified in the mandate agreed 
between the manufacturer and the authorised representative.  

The mandate shall allow and require the authorised representative to perform at least 
the following tasks in relation to the devices that it covers: 

(a)  keep  the  technical  documentation,  the  EU  declaration  of  conformity  and,  if 
applicable, a copy of the relevant certificate including any supplement issued in 
accordance  with  Article  45  at  the  disposal  of  competent  authorities  for  the 
period referred to in Article 8(4); 

(b) 

(c) 

(d) 

in  response  to  a  reasoned  request  from  a  competent  authority,  provide  that 
competent  authority  with  all  the  information  and  documentation  necessary  to 
demonstrate the conformity of a device;  

cooperate  with  the  competent  authorities  on  any  corrective  action  taken  to 
eliminate the risks posed by devices; 

immediately  inform  the  manufacturer  about  complaints  and  reports  from 
healthcare professionals, patients and users about suspected incidents related to 
a device for which they have been designated;  

(e) 

terminate the mandate if the manufacturer acts contrary to his obligations under 
this Regulation.  

To allow the authorised representative to fulfil the tasks mentioned in this paragraph, 
the  manufacturer  shall  at  least  ensure  that  the  authorised  representative  has 
permanent  immediate  access  to  the  necessary  documentation  in  one  of  the  official 
Union languages. 

The  mandate  referred  to  in  paragraph  3  shall  not  include  the  delegation  of  the 
manufacturer's obligations laid down in Article 8(1), (2), (5), (6), (7) and (8). 

An authorised representative who terminates the mandate on the grounds referred to 
in point (e) of paragraph 3 shall immediately inform the competent authority of the 
Member State in which he is established and, where applicable, the notified body that 
was  involved  in  the  conformity  assessment  for  the  device  of  the  termination  of  the 
mandate and the reasons therefor. 

EN 

39 

   EN 

 
6. 

Any  reference  in  this  Regulation  to  the  competent  authority  of  the  Member  State 
where the manufacturer has his registered place of business shall be understood as a 
reference  to  the  competent  authority  of  the  Member  State  where  the  authorised 
representative,  designated  by  a  manufacturer  referred  to  in  paragraph  1,  has  his 
registered place of business.  

Article 10 
Change of authorised representative 

The  modalities  of  a  change  of  authorised  representative  shall  be  clearly  defined  in  an 
agreement between the manufacturer, the outgoing authorised representative and the incoming 
authorised representative. This agreement shall address at least the following aspects:  

(a) 

(b) 

the  date  of  termination  of  the  mandate  with  the  outgoing  authorised 
representative  and  date  of  beginning  of  the  mandate  with  the  incoming 
authorised representative; 

the date until which the outgoing authorised representative may be indicated in 
the  information  supplied  by  the  manufacturer,  including  any  promotional 
material;  

(c) 

the transfer of documents, including confidentiality aspects and property rights; 

(d) 

the  obligation  of  the  outgoing  authorised  representative  after  the  end  of  the 
mandate to forward to the manufacturer or incoming authorised representative 
any complaints or reports from healthcare professionals, patients or users about 
suspected  incidents  related  to  a  device  for  which  he  had  been  designated  as 
authorised representative. 

Article 11 
General obligations of importers  

1. 

2. 

Importers shall place on the Union market only devices that are in conformity with 
this Regulation. 

Before placing a device on the market importers shall ensure the following:  

(a) 

(b) 

(c) 

that the appropriate conformity assessment procedure has been carried out by 
the manufacturer;  

that  an  authorised  representative  in  accordance  with  Article  9  has  been 
designated by the manufacturer; 

that  the  EU  declaration  of  conformity  and  the  technical  documentation  has 
been drawn up by the manufacturer;  

(d) 

that the device bears the required CE marking of conformity;  

(e) 

that the device is labelled in accordance with this Regulation and accompanied 
by the required instructions for use and EU declaration of conformity; 

EN 

40 

   EN 

 
(f) 

that, where applicable, a Unique Device Identification has been assigned by the 
manufacturer in accordance with Article 24. 

Where  an  importer  considers  or  has  reason  to  believe  that  a  device  is  not  in 
conformity with the requirements of this Regulation, he shall not place the device on 
the  market  until  it  has  been  brought  into  conformity.  Where  the  device  presents  a 
risk, the importer shall inform the manufacturer and his authorised representative to 
that  effect,  as  well  as  the  competent  authority  of  the  Member  State  in  which  he  is 
established. 

Importers  shall  indicate  their  name,  registered  trade  name  or  registered  trade  mark 
and the address of their registered place of business at which they can be contacted 
and  their  location  can  be  established  on  the  device  or  on  its  packaging  or  in  a 
document accompanying the device. They shall ensure that any additional label does 
not obscure any information on the label provided by the manufacturer. 

Importers  shall  ensure  that  the  device  is  registered  in  the  electronic  system  in 
accordance with Article 25(2).  

Importers  shall  ensure  that,  while  a  device  is  under  their  responsibility,  storage  or 
transport  conditions  do  not  jeopardise  its  compliance  with  the  general  safety  and 
performance requirements set out in Annex I. 

When deemed appropriate with regard to the risks presented by a device, importers 
shall, in order to protect the health and safety of patients and users, carry out sample 
testing  of  marketed  products,  investigate  complaints  and  keep  a  register  of 
complaints, of non-conforming products and of product recalls and withdrawals, and 
shall  keep  the  manufacturer,  authorised  representative  and  distributors  informed  of 
such monitoring.  

Importers  who  consider  or  have  reason  to  believe  that  a  device  which  they  have 
placed  on  the  market  is  not  in  conformity  with  this  Regulation  shall  immediately 
inform  the  manufacturer  and  his  authorised  representative  and,  if  appropriate,  take 
the  necessary  corrective  action  to  bring  that  device  into  conformity,  withdraw  or 
recall  it.  Where  the  device  presents  a  risk,  they  shall  also  immediately  inform  the 
competent authorities of the Member States in which they made the device available 
and,  if  applicable,  the  notified  body  that  issued  a  certificate  in  accordance  with 
Article  45  for  the  device  in  question,  giving  details,  in  particular,  of  the  non-
compliance and of any corrective action taken. 

Importers  who  have  received  complaints  or  reports  from  healthcare  professionals, 
patients or users about suspected incidents related to a device which they have placed 
on the market shall immediately forward this information to the manufacturer and his 
authorised representative. 

Importers  shall,  for  the  period  referred  to  in  Article  8(4),  keep  a  copy  of  the  EU 
declaration  of  conformity  at  the  disposal  of  the  market  surveillance  authorities  and 
ensure  that  the  technical  documentation  and,  if  applicable,  a  copy  of  the  relevant 
certificate  including  any  supplement,  issued  in  accordance  with  Article  45,  can  be 
made available to those authorities, upon request. By written mandate, the importer 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

EN 

41 

   EN 

 
10. 

1. 

2. 

3. 

4. 

and  the  authorised  representative  for  the  device  in  question  may  agree  that  this 
obligation is delegated to the authorised representative. 

Importers shall, in response to a request from a competent national authority, provide 
it  with  all  the  information  and  documentation  necessary  to  demonstrate  the 
conformity  of  a  product.  This  obligation  shall  be  considered  fulfilled  when  the 
authorised  representative  for 
the  required 
information.  Importers  shall  cooperate  with  a  competent  national  authority,  at  its 
request, on any action taken to eliminate the risks posed by products which they have 
placed on the market. 

in  question  provides 

the  device 

Article 12 
General obligations of distributors 

When making a device available on the market, distributors shall act with due care in 
relation to the requirements applicable. 

Before  making  a  device  available  on  the  market  distributors  shall  verify  that  the 
following requirements are met: 

(a) 

the product bears the required CE marking of conformity;  

(b) 

(c) 

the  product  is  accompanied  by  the  information  to  be  supplied  by  the 
manufacturer in accordance with Article 8(7); 

the  manufacturer  and,  where  applicable,  the  importer  have  complied  with  the 
requirements set out in Article 24 and Article 11(3) respectively. 

Where  a  distributor  considers  or  has  reason  to  believe  that  a  device  is  not  in 
conformity  with  the  requirements  of  this  Regulation,  he  shall  not  make  the  device 
available on the market until it has been brought into conformity. Where the device 
presents a risk, the distributor shall inform the manufacturer and, where applicable, 
his authorised representative and the importer to that effect, as well as the competent 
authority of the Member State in which he is established. 

Distributors shall ensure that, while a device is under their responsibility, storage or 
transport  conditions  do  not  jeopardise  its  compliance  with  the  general  safety  and 
performance requirements set out in Annex I. 

Distributors  who  consider  or  have  reason  to  believe  that  a  device  which  they  have 
made  available  on  the  market  is  not  in  conformity  with  this  Regulation  shall 
immediately  inform  the  manufacturer  and,  where  applicable,  his  authorised 
representative and the importer and make sure that the necessary corrective action to 
bring  that  device  into  conformity,  withdraw  or  recall  it,  if  appropriate,  is  taken. 
Where the device presents a risk, they shall also immediately inform the competent 
authorities  of  the  Member  States  in  which  they  made  the  device  available,  giving 
details, in particular, of the non-compliance and of any corrective action taken.  

5. 

Distributors who have received complaints or reports from healthcare professionals, 
patients  or  users  about  suspected  incidents  related  to  a  device  they  have  made 

EN 

42 

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available, shall immediately forward this information to the manufacturer and, where 
applicable, his authorised representative.  

6. 

Distributors  shall,  in  response  to  a  request  from  a  competent  authority,  provide  it 
with all the information and documentation necessary to demonstrate the conformity 
of  a  device.  This  obligation  shall  be  considered  fulfilled  when  the  authorised 
representative  for  the  device  in  question,  where  applicable,  provides  the  required 
information. Distributors shall cooperate with competent national authorities, at their 
request, on any action taken to eliminate the risks posed by devices which they have 
made available on the market. 

Article 13 
Person responsible for regulatory compliance 

1. 

Manufacturers  shall  have  available  within  their  organisation  at  least  one  qualified 
person who possesses expert knowledge in the field of medical devices. The expert 
knowledge shall be demonstrated by either of the following qualifications: 

(a) 

a  diploma,  certificate  or  other  evidence  of  formal  qualification  awarded  on 
completion of a university degree or of an equivalent course of study, in natural 
sciences,  medicine,  pharmacy,  engineering  or  another  relevant  discipline,  and 
at least two years of professional experience in regulatory affairs or in quality 
management systems relating to medical devices;  

(b) 

five  years  of  professional  experience  in  regulatory  affairs  or  in  quality 
management systems relating to medical devices.  

Without  prejudice  to  national  provisions  regarding  professional  qualifications, 
manufacturers  of  custom-made  devices  may  demonstrate  their  expert  knowledge 
referred to in the first subparagraph by at least two years of professional experience 
within the relevant field of manufacture.  

This  paragraph  shall  not  apply  to  manufacturers  of  custom-made  devices  who  are 
micro-enterprises as defined by Commission Recommendation 2003/361/EC54. 

2. 

The qualified person shall at least be responsible for ensuring the following matters:  

(a) 

(b) 

that  the  conformity  of  the  devices  is  appropriately  assessed  before  a  batch  is 
released; 

that the  technical documentation and  the declaration  of  conformity are  drawn 
up and kept up-to-date;  

(c) 

that the reporting obligations in accordance with Articles 61 to 66 are fulfilled; 

(d) 

in the case of investigational devices, that the statement referred to in point 4.1 
of Chapter II of Annex XIV is issued.  

54 

OJ L 124, 20.5.2003, p. 36 

EN 

43 

   EN 

 
                                                 
3. 

4. 

The  qualified  person  shall  suffer  no  disadvantage  within  the  manufacturer's 
organisation in relation to the proper fulfilment of his duties. 

Authorised representatives shall have available within their organisation at least one 
qualified  person  who  possesses  expert  knowledge  regarding  the  regulatory 
requirements  for  medical  devices  in  the  Union.  The  expert  knowledge  shall  be 
demonstrated by either of the following qualifications: 

(a) 

a  diploma,  certificate  or  other  evidence  of  formal  qualification  awarded  on 
completion of a university degree or of an equivalent course of study, in law, 
natural  sciences,  medicine,  pharmacy,  engineering  or  another  relevant 
discipline,  and  at  least  two  years  of  professional  experience  in  regulatory 
affairs or in quality management systems relating to medical devices;  

(b) 

five  years  of  professional  experience  in  regulatory  affairs  or  in  quality 
management systems relating to medical devices. 

Article 14 
Cases in which obligations of manufacturers apply to importers, distributors or other persons 

1. 

A distributor, importer or other natural or legal person shall assume the obligations 
incumbent on manufacturers if he does any of the following: 

(a)  makes available on the market a device under his name, registered trade name 

or registered trade mark;  

(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 number (19) of Article 2(1), assembles or adapts a device 
already on the market to its intended purpose for an individual patient. 

2. 

For the purposes of point (c) of paragraph 1, the following shall not be considered to 
be  a  modification  of  a  device  that  could  affect  its  compliance  with  the  applicable 
requirements: 

(a)  provision, 

including 

translation,  of 

the 
manufacturer  in  accordance  with  Section  19  of  Annex  I  relating  to  a  device 
already placed on the market and of further information which is necessary in 
order to market the product in the relevant Member State; 

information  supplied  by 

the 

(b) 

changes  to  the  outer  packaging  of  a  device  already  placed  on  the  market, 
including  a  change  of  pack  size,  if  the  repackaging  is  necessary  in  order  to 
market the product in the relevant Member State and if it is carried out in such 
conditions that the original condition of the device cannot be affected by it. In 
the  case  of  devices  placed  on  the  market  in  sterile  condition,  it  shall  be 
presumed that the original condition of the device is adversely affected if the 

EN 

44 

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package that shall ensure the sterile condition is opened, damaged or otherwise 
negatively affected by the repackaging. 

A distributor or importer who carries out any of the activities mentioned in points (a) 
and (b) of paragraph 2 shall indicate the activity carried out together with his name, 
registered  trade  name  or  registered  trade  mark  and  the  address  at  which  he  can  be 
contacted  and  his  location  can  be  established  on  the  device  or,  where  that  is  not 
possible, on its packaging or in a document accompanying the device.  

He  shall  ensure  that  he  has  in  place  a  quality  management  system  that  includes 
procedures  which  ensure  that  the  translation  of  information  is  accurate  and  up-to-
date,  and  that  the  activities  mentioned  in  points  (a)  and  (b)  of  paragraph  2  are 
performed by means and under conditions that preserve the original condition of the 
device  and  that  the  packaging  of  the  repackaged  device  is  not  defective,  of  poor 
quality  or  untidy.  Part  of  the  quality  management  system  shall  be  procedures 
ensuring that the distributor or importer is informed of any corrective action taken by 
the  manufacturer  in  relation  to  the  device  in  question  in  order  to  respond  to  safety 
issues or to bring it in conformity with this Regulation. 

Prior  to  making  the  relabelled  or  repackaged  device  available,  the  distributor  or 
importer referred to in paragraph 3 shall inform the manufacturer and the competent 
authority of the Member State where he plans to make the device available and, upon 
request,  shall  provide  them  with  a  sample  or  a  mock-up  of  the  relabelled  or 
repackaged  device,  including  any  translated label  and  instructions  for  use.  He  shall 
submit to the competent authority a certificate, issued by a notified body referred to 
in  Article  29,  designated  for  the  type  of  devices  that  are  subject  to  activities 
mentioned in points (a) and (b) of paragraph 2, attesting that the quality management 
system complies with the requirements laid down in paragraph 3. 

Article 15 
Single-use devices and their reprocessing 

Any natural or legal person who reprocesses a single-use device to make it suitable 
for  further  use  within  the  Union  shall  be  considered  to  be  the  manufacturer  of  the 
reprocessed device and shall assume the obligations incumbent on manufacturers laid 
down in this Regulation. 

Only  single-use  devices  that  have  been  placed  on  the  Union  market  in  accordance 
with this Regulation, or prior to [date of application of this Regulation] in accordance 
with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed.  

In  the  case  of  reprocessing  of  single-use  devices  for  critical  use,  only  reprocessing 
that is considered safe according to the latest scientific evidence may be carried out.  

The  Commission,  by  means  of  implementing  acts,  shall  establish  and  regularly 
update a list of categories or groups of single-use devices for critical use which may 
be  reprocessed  in  accordance  with  paragraph  3.  Those  implementing  acts  shall  be 
adopted in accordance with the examination procedure referred to in Article 88(3).  

The name and address of the legal or natural person referred to in paragraph 1 and 
the  other  relevant  information  in  accordance  with  Section  19  of  Annex  I  shall  be 

3. 

4. 

1. 

2. 

3. 

4. 

5. 

EN 

45 

   EN 

 
indicated  on  the  label  and,  where  applicable,  in  the  instructions  for  use  of  the 
reprocessed device.  

The name and address of the manufacturer of the original single-use device shall no 
longer appear on the label, but shall be mentioned in the instructions for use of the 
reprocessed device.  

6. 

A  Member  State  may  maintain  or  introduce  national  provisions  prohibiting,  within 
its territory, on grounds of protection of public health specific to that Member State 
the following: 

(a) 

the reprocessing of single-use devices and the transfer of single-use devices to 
another Member State or to a third country with a view to their reprocessing;  

(b) 

the making available of reprocessed single-use devices. 

Member  States  shall  notify  the  Commission  and  the  other  Member  States  of  the 
national  provisions  and  the  grounds  for  introducing  them.  The  Commission  shall 
keep the information publicly available.  

Article 16 
Implant card 

1. 

The manufacturer of an implantable device shall provide together with the device an 
implant  card  which  shall  be  made  available  to  the  particular  patient  who  has  been 
implanted with the device.  

2. 

This card shall contain the following: 

(a) 

(b) 

the  information  allowing  identification  of  the  device,  including  the  Unique 
Device Identification; 

any  warnings,  precautions  or  measures  to  be  taken  by  the  patient  or  a 
healthcare  professional  with  regard  to  reciprocal  interference  with  reasonably 
foreseeable external influences or environmental conditions; 

(c) 

any  information  about  the  expected  lifetime  of  the  device  and  any  necessary 
follow-up. 

The information shall be written in a way that is readily understood by a lay person.  

Article 17 
EU declaration of conformity 

1. 

The  EU  declaration  of  conformity  shall  state  that  fulfilment  of  the  requirements 
specified in this Regulation has been demonstrated. It shall be continuously updated. 
The minimum content of the EU declaration of conformity is set out in Annex III. It 
shall  be  translated  into  the  official  Union  language  or  languages  required  by  the 
Member State(s) in which the device is made available.  

EN 

46 

   EN 

 
2. 

3. 

4. 

1. 

2. 

3. 

4. 

5. 

6. 

Where,  concerning  aspects  not  covered  by  this  Regulation,  devices  are  subject  to 
other  Union  legislation  which  also  requires  a  declaration  of  conformity  by  the 
manufacturer  that  fulfilment  of  the  requirements  of  that  legislation  has  been 
demonstrated, a single EU declaration of conformity shall be drawn up in respect of 
all  Union  acts  applicable  to  the  device  containing  all  information  required  for 
identification of the Union legislation to which the declaration relates.  

By  drawing  up  the  EU  declaration  of  conformity,  the  manufacturer  shall  assume 
responsibility for compliance with the requirements of this Regulation and all other 
Union legislation applicable to the device. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 89 amending or supplementing the minimum content of the EU declaration of 
conformity set out in Annex III in the light of technical progress.  

Article 18 
CE marking of conformity 

Devices,  other  than  custom-made  or  investigational  devices,  considered  to  be  in 
conformity  with  the  requirements  of  this  Regulation  shall  bear  the  CE  marking  of 
conformity, as presented in Annex IV. 

The  CE  marking  shall  be  subject  to  the  general  principles  set  out  in  Article  30  of 
Regulation (EC) No 765/2008. 

The  CE  marking  shall  be  affixed  visibly,  legibly  and  indelibly  to  the  device  or  its 
sterile pack. Where that is not possible or not warranted on account of the nature of 
the device, it shall be affixed to the packaging. The CE marking shall also appear in 
the instructions for use and on the sales packaging where those are provided.  

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 indicating a special risk or use.  

Where applicable, the CE marking shall be followed by the identification number of 
the  notified  body  responsible  for  the  conformity  assessment  procedures  set  out  in 
Article  42.  The  identification  number  shall  also  be  indicated  in  any  promotional 
material which mentions that a device fulfils the legal requirements for CE marking.  

Where devices are subject to other Union legislation concerning other aspects which 
also provide for the affixing of the CE marking, the CE marking shall indicate that 
the devices also fulfil the provisions of the other legislation. 

Article 19 
Devices for special purposes 

1. 

Member States shall not create any obstacle to the following devices: 

(a) 

investigational  devices  which  are  supplied  to  a  doctor  of  medicine,  a  dental 
practitioner or an authorised person for the purpose of clinical investigation if 
they meet the conditions laid down in Articles 50 to 60 and in Annex XIV;  

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47 

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2. 

3. 

1. 

(b) 

custom-made devices which are made available on the market if they comply 
with Article 42(7) and Annex XI. 

Those  devices  shall  not  bear  the  CE  marking,  with  the  exception  of  the  devices 
referred to in Article 54.  

Custom-made devices shall be accompanied by the statement referred to in Annex XI 
which shall be made available to the particular patient or user identified by name, an 
acronym or a numerical code. 

Member States may require that the manufacturer of a custom-made device submit to 
the  competent  authority  a  list  of  such  devices  which  have  been  made  available  in 
their territory. 

At trade fairs, exhibitions, demonstrations or similar events, Member States shall not 
create  any  obstacle  to  the  showing  of  devices  which  do  not  comply  with  this 
Regulation,  provided  a  visible  sign  clearly  indicates  that  such  devices  are  intended 
for presentation or demonstration purposes only and cannot be made available until 
they have been made to comply with this Regulation.  

Article 20 
Systems and procedure packs 

Any natural or legal person shall draw up a statement referred to in paragraph 2 if he 
puts  devices  bearing  the  CE  marking  together  with  the  following  other  devices  or 
products,  in  accordance  with  the  intended  purpose  of  the  devices  or  other  products 
and within the limits of use specified by their manufacturers, in order to place them 
on the market as a system or procedure pack:  

– 

– 

– 

other devices bearing the CE marking; 

in vitro diagnostic medical devices bearing the CE marking in conformity with 
Regulation (EU) […/…]; 

other products which are in conformity with the legislation applicable to those 
products.  

2. 

In the statement, the person referred to in paragraph 1 shall declare the following: 

(a) 

(b) 

(c) 

that he verified the mutual compatibility of the devices and, if applicable other 
products, in accordance with the manufacturers' instructions and has carried out 
his operations in accordance with those instructions; 

that  he  packaged  the  system  or  procedure  pack  and  supplied  relevant 
information  to  users  incorporating  the  information  to  be  supplied  by  the 
manufacturers of the devices or other products which have been put together; 

that the activity of putting devices and, if applicable, other products together as 
a  system  or  procedure  pack  was  subject  to  appropriate  methods  of  internal 
monitoring, verification and validation. 

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3. 

4. 

5. 

1. 

2. 

Any natural or legal person who sterilises systems or procedure packs referred to in 
paragraph 1 for the purpose of placing them on the market shall, at his choice, follow 
one  of  the  procedures  referred  to  in  Annex  VIII  or  in  Part  A  of  Annex  X.  The 
application  of  those  Annexes  and  the  involvement  of  the  notified  body  shall  be 
limited  to  the  aspects  of  the  procedure  relating  to  ensuring  sterility  until  the  sterile 
package is opened or damaged. The person shall draw up a statement declaring that 
sterilisation has been carried out in accordance with the manufacturer's instructions. 

Where the system or procedure pack incorporate devices which do not bear the CE 
marking  or  where  the  chosen  combination  of  devices  is  not  compatible  in  view  of 
their  original  intended  purpose,  the  system  or  procedure  pack  shall  be  treated  as  a 
device in its own right and shall be subjected to the relevant conformity assessment 
procedure pursuant to Article 42. 

The systems or procedure packs referred to in paragraph 1 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 paragraph 1 as well as the address 
at  which  he  can  be  contacted  and  his  location  can  be  established.  Systems  or 
procedure packs shall be accompanied by the information referred to in Section 19 of 
Annex I. The statement referred to in paragraph 2 of this Article shall be kept at the 
disposal  of  the  competent  authorities,  after  the  system  or  procedure  pack  has  been 
put  together,  for  the  period  that  is  applicable  to  the  devices  put  together  in 
accordance  with  Article  8(4).  Where  these  periods  differ,  the  longest  period  shall 
apply.  

Article 21 
Parts and components 

Any  natural  or  legal  person  who  makes  available on  the market an article  intended 
specifically to replace an identical or similar integral part or component of a device 
that  is  defective  or  worn  in  order  to  maintain  or  re-establish  the  function  of  the 
device without significantly changing its performance or safety characteristics, shall 
ensure  that  the  article  does  not  adversely  affect  the  safety  and  performance  of  the 
device.  Substantiating  evidence  shall  be  kept  available  to  the  competent  authorities 
of the Member States.  

An article that is intended specifically to replace a part or component of a device and 
that significantly changes the performance or safety characteristics of the device shall 
be considered a device. 

Article 22 
Free movement 

Member States shall not refuse, prohibit or restrict the making available or putting into service 
within their territory of devices which comply with the requirements of this Regulation. 

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49 

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Chapter III 
Identification and traceability of devices, registration of devices 
and of economic operators, summary of safety and clinical 
performance, European databank on medical devices  

Article 23 
Identification within the supply chain 

For devices, other than custom-made or investigational devices, economic operators shall be 
able to identify the following, for the period referred to in Article 8(4): 

(a) 

any economic operator to whom they have supplied a device; 

(b) 

any economic operator who has supplied them with a device; 

(c) 

any health institution or healthcare professional to whom they have supplied a 
device. 

Upon request, they shall inform the competent authorities thereof.  

Article 24 
Unique Device Identification system 

1. 

For  devices,  other  than  custom-made  and  investigational  devices,  a  system  for 
Unique  Device  Identification  shall  be  put  in  place  in  the  Union.  The  UDI  system 
shall  allow  the  identification  and  traceability  of  devices  and  shall  consist  of  the 
following: 

(a)  production of a UDI that comprises the following: 

(i) 

a  device  identifier  specific  to  a  manufacturer  and  a  device  model, 
providing access to the information laid down in Part B of Annex V;  

(ii) 

a  production  identifier  that  identifies  data  related  to  the  unit  of  device 
production; 

(b)  placement of the UDI on the label of the device; 

(c) 

storage  of  the  UDI  by  the  economic  operators  and  the  health  institutions 
through electronic means; 

(d) 

establishment of an electronic system on UDI. 

2. 

The  Commission  shall  designate  one  or  several  entities  that  operate  a  system  for 
assignment of UDIs pursuant to this Regulation and that satisfy all of the following 
criteria: 

(a) 

the entity is an organisation with legal personality; 

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50 

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(b) 

(c) 

(d) 

its system for the assignment of UDIs is adequate to identify a device through 
its distribution and use in accordance with the requirements of this Regulation; 

its  system  for  the  assignment  of  UDIs  conforms  to  the  relevant  international 
standards; 

the entity gives access to its system for the assignment of UDIs to all interested 
users according to a set of predetermined and transparent terms and conditions; 

(e) 

the entity undertakes the following: 

(i) 

(ii) 

to  operate  its  system  for  the  assignment  of  UDIs  for  the  period  to  be 
determined in the designation which shall at least be three years after its 
designation;  

to  make  available  to  the  Commission  and  to  the  Member  States,  upon 
request,  information  concerning  its  system  for  the  assignment  of  UDIs 
and  concerning  manufacturers  that  place  an  UDI  on  the  label  of  their 
device in accordance with the entity's system; 

(iii) 

to remain in compliance with the criteria for designation and the terms of 
designation during the period for which it is designated.  

3. 

4. 

5. 

6. 

7. 

Before placing a device on the market, the manufacturer shall assign to the device a 
UDI  provided  by  an  entity  designated  by  the  Commission  in  accordance  with 
paragraph  2,  if  that  device  belongs  to  the  devices,  categories  or  groups  of  devices 
determined by a measure referred to in point (a) of paragraph 7.  

The UDI shall be placed on the label of the device, in accordance with the conditions 
laid down by a measure referred to in point (c) of paragraph 7. It shall be used for 
reporting  serious  incidents  and  field  safety  corrective  actions  in  accordance  with 
Article  61  and  shall  be  included  in  the  implant  card  referred  to  in  Article  16.  The 
device  identifier  shall  appear  on  the  EU  declaration  of  conformity  referred  to  in 
Article 17 and in the technical documentation referred to in Annex II.  

Economic operators and health institutions shall store and keep, by electronic means, 
the  device  identifier  and  the  production  identifier  of  the  devices  which  they  have 
supplied or they have been supplied with, if they belong to the devices, categories or 
groups of devices determined by a measure referred to in point (a) of paragraph 7. 

The Commission, in cooperation with the Member States, shall set up and manage an 
electronic system on UDI to collate and process the information mentioned in Part B 
of Annex V. This information shall be accessible to the public. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 89:  

(a)  determining  the  devices,  categories  or  groups  of  devices  whose  identification 
shall  be  based  on  the  UDI  system  as  set  out  in  paragraphs  1  to  6,  and  the 
risk-based  approach, 
timelines 
implementation  of  the  UDI  system  shall  be  gradual,  starting  with  devices 
falling in the highest risk class; 

this.  Following  a 

implementing 

for 

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(b) 

specifying the data to be included in the production identifier which, following 
a risk based approach, may vary depending on the risk class of the device; 

(c)  defining  the  obligations  of  economic  operators,  of  health  institutions  and  of 
professional  users,  in  particular  regarding  allocation  of  the  numeric  or 
alphanumeric  characters,  placement  of  the  UDI  on  the  label,  storage  of 
information  in  the  electronic  system  on  UDI  and  use  of  the  UDI  in 
documentation  and  reporting  related  to  the  device  provided  for  in  this 
Regulation; 

(d) 

amending or supplementing the list of information set out in Part B of Annex V 
in the light of technical progress. 

8. 

When adopting the measures referred to in paragraph 7, the Commission shall take 
into account the following: 

(a) 

the protection of personal data; 

(b) 

the legitimate interest in protecting commercially sensitive information; 

(c) 

the risk-based approach; 

(d) 

the cost-effectiveness of the measures; 

(e) 

the convergence of UDI systems developed at international level.  

1. 

2. 

3. 

4. 

5. 

Article 25 
Electronic system on registration of devices and economic operators 

The Commission, in collaboration with the Member States, shall set up and manage 
an  electronic  system  to  collate  and  process  information  that  is  necessary  and 
proportionate  to  describe  and  identify  the  device  and  to  identify  the  manufacturer 
and,  where  applicable,  the  authorised  representative  and  the  importer.  The  details 
regarding the information to be submitted by the economic operators are laid down in 
Part A of Annex V. 

Before a device, other than a custom-made or investigational device, is placed on the 
market  the  manufacturer  or  his  authorised  representative  shall  submit  to  the 
electronic system the information referred to in paragraph 1.  

Within one week after placing a device, other than a custom-made or investigational 
device, on the market, importers shall submit to the electronic system the information 
referred to in paragraph 1.  

Within one week of any change occurring in relation to the information referred to in 
paragraph  1,  the  relevant  economic  operator  shall  update  the  data  in  the  electronic 
system. 

Not  later  than  two  years  after  submission  of  the  information  in  accordance  with 
paragraphs 2 and 3, and then every second year, the relevant economic operator shall 
confirm the accuracy of the data. In the event of failure to confirm within six months 

EN 

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6. 

7. 

1. 

2. 

of  the  due  date,  any  Member  State  may  take  measures  to  suspend  or  otherwise 
restrict  the  making  available  of  the  device  in  question  within  its  territory  until  the 
obligation referred to in this paragraph is complied with.  

The data contained in the electronic system shall be accessible to the public.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  89  amending  the  list  of  information  to  be  submitted  as  set  out  in  Part  A  of 
Annex V in the light of technical progress.  

Article 26 
Summary of safety and clinical performance 

In  the  case  of  devices  classified  as  class  III  and  implantable  devices,  other  than 
custom-made or investigational devices, the manufacturer shall draw up a summary 
of  safety  and  clinical  performance.  It  shall  be  written  in  a  way  that  is  clear  to  the 
intended  user.  The  draft  of  this  summary  shall  be  part  of  the  documentation  to  be 
submitted to the notified body involved in the conformity assessment in accordance 
with Article 42 and shall be validated by that body.  

The  Commission  may,  by  means  of  implementing  acts,  set  out  the  form  and  the 
presentation of the data elements to be included in the summary of safety and clinical 
performance.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
advisory procedure referred to in Article 88(2).  

Article 27 
European databank 

1. 

The  Commission  shall  develop  and  manage  the  European  databank  on  medical 
devices (Eudamed) for the following purposes:  

(a) 

to  enable  the  public  to  be  adequately  informed  about  devices  placed  on  the 
market,  about  the  corresponding  certificates  issued  by  notified  bodies  and 
about the relevant economic operators; 

(b) 

to enable traceability of devices within the internal market; 

(c) 

(d) 

(e) 

to enable the public to be adequately informed about clinical investigations and 
to enable sponsors of clinical investigations to be conducted in more than one 
Member State to comply with information obligations under Articles 50 to 60; 

to enable manufacturers to comply with information obligations under Articles 
61 to 66; 

to enable the competent authorities of the Member States and the Commission 
to carry out their tasks relating to this Regulation on a well informed basis and 
to enhance the cooperation between them.  

2. 

Eudamed shall include the following as integral parts: 

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(a) 

the electronic system on UDI referred to in Article 24;  

(b) 

the  electronic  system  on  registration  of  devices  and  economic  operators 
referred to in Article 25; 

(c) 

the electronic system on information on certificates referred to in Article 45(4);  

(d) 

the electronic system on clinical investigations referred to in Article 53, 

(e) 

the electronic system on vigilance referred to in Article 62; 

(f) 

the electronic system on market surveillance referred to in Article 68. 

The  data  shall  be  entered  into  Eudamed  by  the  Member  States,  notified  bodies, 
economic  operators  and  sponsors  as  specified  in  the  provisions  concerning  the 
electronic systems referred to in paragraph 2. 

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 operators, sponsors and the public to the extent defined in 
the provisions referred to in paragraph 2.  

Eudamed  shall  contain  personal  data  only  insofar  as  this  is  necessary  for  the 
electronic systems referred to in paragraph 2 to collate and process the information in 
accordance with this Regulation. Personal data shall be kept in a form which permits 
identification of the data subjects for no longer than the periods referred to in Article 
8(4).  

The  Commission  and  the  Member  States  shall  ensure  that  the  data  subjects  may 
effectively exercise their rights to information, to access, to rectify and to object in 
accordance with Regulation (EC) No 45/2001 and Directive 95/46/EC, respectively. 
They shall ensure that the data subjects may effectively exercise the right of access to 
data relating to them, and the right to have inaccurate or incomplete data corrected 
and erased. Within their respective responsibilities, the Commission and the Member 
States  shall  ensure  that  inaccurate  and  unlawfully  processed  data  is  deleted,  in 
accordance with the applicable legislation. Corrections and deletions shall be carried 
out as soon as possible, but no later than within 60 days after a request is made by a 
data subject. 

The  Commission  shall,  by  means  of  implementing  acts,  lay  down  the  modalities 
necessary  for  the  development  and  management  of  Eudamed.  Those  implementing 
acts  shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 88(3). 

In relation to its responsibilities under this Article and the processing of personal data 
involved therein, the Commission shall be considered controller of Eudamed and its 
electronic systems. 

3. 

4. 

5. 

6. 

7. 

8. 

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Chapter IV 
Notified bodies 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

Article 28 
National authorities responsible for notified bodies 

A Member State that intends to designate a conformity assessment body as a notified 
body,  or  has  designated  a  notified  body,  to  carry  out  third-party  conformity 
assessment  tasks  under  this  Regulation  shall  designate  an  authority  that  shall  be 
responsible  for  setting  up  and  carrying  out  the  necessary  procedures  for  the 
assessment, designation and notification of conformity assessment bodies and for the 
monitoring  of  notified  bodies,  including  subcontractors  or  subsidiaries  of  those 
bodies,  hereinafter  referred  to  as  the  ‘national  authority  responsible  for  notified 
bodies’. 

The national authority responsible for notified bodies shall be established, organised 
and operated so as to safeguard the objectivity and impartiality of its activities and to 
avoid any conflicts of interests with conformity assessment bodies.  

It  shall  be  organised  so  that  each  decision  relating  to  notification  of  a  conformity 
assessment  body  is  taken  by  personnel  different  from  those  who  carried  out  the 
assessment of the conformity assessment body. 

It  shall  not  perform  any  activities  that  conformity  assessment  bodies  perform  nor 
provide consultancy services on a commercial or competitive basis.  

The  national  authority  responsible  for  notified  bodies  shall  safeguard 
the 
confidentiality of the information it obtains. However, it shall exchange information 
on a notified body with other Member States and the Commission.  

The national authority responsible for notified bodies shall have a sufficient number 
of competent personnel at its disposal for the proper performance of its tasks.  

Without prejudice to Article 33(3), where a national authority is responsible for the 
designation of notified bodies in the field of products other than medical devices, the 
competent authority for medical devices shall be consulted on all aspects specifically 
related to medical devices.  

Member  States  shall  provide  the  Commission  and  the  other  Member  States  with 
information  on  their  procedures  for  the  assessment,  designation  and  notification  of 
conformity assessment bodies and for the monitoring of notified bodies, and of any 
changes thereto. 

The  national  authority  responsible  for  notified  bodies  shall  be  peer-reviewed  every 
second  year.  The  peer-review  shall  include  an  on-site  visit  to  a  conformity 
assessment  body  or  a  notified  body  under  the  responsibility  of  the  reviewed 
authority.  In  the  case  referred  to  in  the  second  subparagraph  of  paragraph  6,  the 
competent authority for medical devices shall participate in the peer-review.  

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The  Member  States  shall  draw  up  the  annual  plan  for  the  peer-review,  ensuring  an 
appropriate rotation in respect of reviewing and reviewed authorities, and submit it to 
the Commission. The Commission may participate in the review. The outcome of the 
peer-review shall be communicated to all Member States and to the Commission and 
a summary of the outcome shall be made publicly available. 

Article 29 
Requirements relating to notified bodies 

Notified  bodies  shall  satisfy  the  organisational  and  general  requirements  and  the 
quality  management,  resource  and  process  requirements  that  are  necessary  to  fulfil 
their  tasks  for  which  they  are  designated  in  accordance  with  this  Regulation. 
Minimum requirements to be met by notified bodies are set out in Annex VI.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  89  amending  or  supplementing  the  minimum  requirements  in  Annex  VI,  in 
the light of technical progress and considering the minimum requirements needed for 
the assessment of specific devices, or categories or groups of devices. 

Article 30 
Subsidiaries and subcontracting 

Where  a  notified  body  subcontracts  specific  tasks  connected  with  conformity 
assessment  or  has  recourse  to  a  subsidiary  for  specific  tasks  connected  with 
conformity assessment, it shall verify that the subcontractor or the subsidiary meets 
the relevant requirements set out in Annex VI and shall inform the national authority 
responsible for notified bodies accordingly. 

Notified bodies shall take full responsibility for the tasks performed on their behalf 
by subcontractors or subsidiaries. 

Conformity assessment activities may be subcontracted or carried out by a subsidiary 
only  with  the  agreement  of  the  legal  or  natural  person  that  applied  for  conformity 
assessment. 

Notified  bodies  shall  keep  at  the  disposal  of  the  national  authority  responsible  for 
the 
notified  bodies 
qualifications of the subcontractor or the subsidiary and the work carried out by them 
under this Regulation. 

the  relevant  documents  concerning 

the  verification  of 

Article 31 
Application by a conformity assessment body for notification 

A  conformity  assessment  body  shall  submit  an  application  for  notification  to  the 
national authority responsible for notified bodies of the Member State in which it is 
established. 

The  application  shall  specify  the  conformity  assessment  activities,  the  conformity 
assessment procedures and the devices for which the body claims to be competent, 

1. 

2. 

1. 

2. 

3. 

4. 

1. 

2. 

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3. 

1. 

2. 

3. 

4. 

supported by documentation proving compliance with all the requirements set out in 
Annex VI.  

In  respect  of  the  organisational  and  general  requirements  and  the  quality 
management  requirements  set  out  in  Sections  1  and  2  of  Annex  VI,  the  relevant 
documentation may be submitted in form of a valid certificate and the corresponding 
evaluation  report  delivered  by  a  national  accreditation  body  in  accordance  with 
Regulation (EC) No  765/2008.  The  conformity assessment body shall be presumed 
to  be  in  conformity  with  the  requirements  covered  by  the  certificate  delivered  by 
such accreditation body. 

After being designated, the notified body shall update the documentation referred to 
in  paragraph  2  whenever  relevant  changes  occur  in  order  to  enable  the  national 
authority  responsible  for  notified  bodies  to  monitor  and  verify  continuous 
compliance with all the requirements set out in Annex VI.  

Article 32 
Assessment of the application 

The national authority responsible for notified bodies shall check that the application 
referred to in Article 31 is complete and draw up a preliminary assessment report.  

It  shall  submit  the  preliminary  assessment  report  to  the  Commission  which  shall 
immediately  transmit  it  to  the  Medical  Device  Coordination  Group  established  by 
Article  78  (‘MDCG’).  Upon  request  by  the  Commission,  the  report  shall  be 
submitted by the authority in up to three official Union languages.  

Within 14 days of the submission referred to in paragraph 2, the Commission shall 
designate a joint assessment team made up of at least two experts chosen from a list 
of experts who are qualified in the assessment of conformity assessment bodies. The 
list shall be drawn up by the Commission in cooperation with the MDCG. At least 
one of these experts shall be a representative of the Commission who shall lead the 
joint assessment team. 

Within 90 days after designation of the joint assessment team, the national authority 
responsible  for  notified  bodies  and  the  joint  assessment  team  shall  review  the 
documentation  submitted  with  the  application  in  accordance  with  Article  31  and 
conduct  an  on-site  assessment  of  the  applicant  conformity  assessment  body  and, 
where  relevant,  of  any  subsidiary  or  sub-contractor,  located  inside  or  outside  the 
Union, to be involved in the conformity assessment process. Such on-site assessment 
shall not cover requirements for which the applicant conformity assessment body has 
received  a  certificate  delivered  by  the  national  accreditation  body  as  referred  to  in 
Article  31(2),  unless  the  Commission  representative  mentioned  in  Article  32(3) 
requests the on-site assessment.  

Findings regarding non-compliance of a body with the requirements set out in Annex 
VI shall be raised during the assessment process and discussed between the national 
authority responsible for notified bodies and the joint assessment team with a view to 
finding  common  agreement  with  respect  to  the  assessment  of  the  application. 

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5. 

6. 

7. 

1. 

2. 

3. 

4. 

5. 

Divergent  opinions  shall  be  identified  in  the  assessment  report  of  the  national 
authority responsible. 

The  national  authority  responsible  for  notified  bodies  shall  submit  its  assessment 
report and its draft notification to the Commission which shall immediately transmit 
those  documents  to  the  MDCG  and  to  the  members  of  the  joint  assessment  team. 
Upon  request  by  the  Commission,  those  documents  shall  be  submitted  by  the 
authority in up to three official Union languages.  

The joint assessment team shall provide its opinion regarding the assessment report 
and  the  draft  notification  within  21  days  of  receipt  of  those  documents  and  the 
Commission  shall  immediately  submit  this  opinion  to  the  MDCG.  Within  21  days 
after  receipt  of  the  opinion  of  the  joint  assessment  team,  the  MDCG  shall  issue  a 
recommendation  with  regard  to  the  draft  notification  which  the  relevant  national 
authority shall duly take into consideration for its decision on the designation of the 
notified body. 

The  Commission  may,  by  means  of  implementing  acts,  adopt  measures  setting  out 
the  modalities  for  the  application  for  notification  referred  to  in  Article  31  and  the 
assessment of the application set out in this Article. Those implementing acts shall be 
adopted in accordance with the examination procedure referred to in Article 88(3). 

Article 33 
Notification procedure 

Member  States  shall  notify  the  Commission  and  the  other  Member  States  of  the 
conformity assessment bodies they have designated, using the electronic notification 
tool developed and managed by the Commission. 

Member  States  may  notify  only  conformity  assessment  bodies  which  satisfy  the 
requirements set out in Annex VI.  

Where  a  national  authority  responsible  for  notified  bodies  is  responsible  for 
designation of notified bodies in the field of products other than medical devices, the 
competent  authority  for  medical  devices  shall  provide,  prior  to  the  notification,  a 
positive opinion on the notification and its scope.  

The  notification  shall  clearly  specify  the  scope  of  the  designation  indicating  the 
conformity assessment activities, the conformity assessment procedures and the type 
of devices which the notified body is authorised to assess.  

The Commission may, by means of implementing acts, set up a list of codes and the 
corresponding  types  of  devices  to  define  the  scope  of  the  designation  of  notified 
bodies  which  the  Member  States  shall  indicate  in  their  notification.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  advisory  procedure 
referred to in Article 88(2). 

The notification shall be accompanied by the final assessment report of the national 
authority  responsible  for  notified  bodies,  the  opinion  of  the  joint  assessment  team 
and the recommendation of the MDCG. Where the notifying Member State does not 

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6. 

7. 

8. 

9. 

10. 

1. 

2. 

1. 

follow  the  recommendation  of  the  MDCG,  it  shall  provide  a  duly  substantiated 
justification. 

The  notifying  Member  State  shall  provide  the  Commission  and  the  other  Member 
States with documentary evidence regarding the arrangements in place to ensure that 
the  notified  body  will  be  monitored  regularly  and  will  continue  to  satisfy  the 
requirements  set  out  in  Annex  VI.  It  shall  furthermore  submit  evidence  of  the 
availability  of  competent  personnel  for  monitoring  the  notified  body  in  accordance 
with Article 28(6). 

Within  28  days  of  a  notification,  a  Member  State  or  the  Commission  may  raise 
written objections, setting out its arguments, with regard either to the notified body 
or to its monitoring by the national authority responsible for notified bodies. 

When  a  Member  State  or  the  Commission  raises  objections  in  accordance  with 
paragraph  7,  the  effect  of  the  notification  shall  be  suspended.  In  this  case,  the 
Commission shall bring the matter before the MDCG within 15 days after expiry of 
the  period  referred  to  in  paragraph  7.  After  consulting  the  parties  involved,  the 
MDCG  shall  give  its  opinion  at  the  latest  within  28  days  after  the  matter  has  been 
brought before it. If the notifying Member State does not agree with the opinion of 
the MDCG, it may request the Commission to give its opinion.  

Where no objection is raised in accordance with paragraph 7 or where the MDCG or 
the Commission, after having been consulted in accordance with paragraph 8, is of 
the opinion that the notification may be accepted fully or partially, the Commission 
shall publish the notification accordingly.  

The  notification  shall  become  valid  the  day  after  its  publication  in  the  database  of 
notified  bodies  developed  and  managed  by  the  Commission.  The  published 
notification shall determine the scope of lawful activity of the notified body.  

Article 34 
Identification number and list of notified bodies 

The  Commission  shall  assign  an  identification  number  to  each  notified  body  for 
which  the  notification  is  accepted  in  accordance  with  Article  33.  It  shall  assign  a 
single identification number even when the body is notified under several Union acts. 

The  Commission  shall  make  the  list  of  the  bodies  notified  under  this  Regulation, 
including  the  identification  numbers  that  have  been  assigned  to  them  and  the 
activities  for  which  they  have  been  notified,  accessible  to  the  public.  The 
Commission shall ensure that the list is kept up to date. 

Article 35 
Monitoring of notified bodies 

The national authority responsible for notified bodies shall continuously monitor the 
notified bodies to ensure ongoing compliance with the requirements set out in Annex 
VI.  The  notified  bodies  shall,  on  request,  supply  all  relevant  information  and 
documents, required to enable the authority to verify compliance with those criteria. 

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2. 

3. 

4. 

5. 

1. 

2. 

Notified  bodies  shall,  without  delay,  inform  the  national  authority  responsible  for 
notified  bodies  of  any  changes,  in  particular  regarding  their  personnel,  facilities, 
subsidiaries  or  subcontractors,  which  may  affect  compliance  with  the  requirements 
set out in Annex VI or their ability to conduct the conformity assessment procedures 
relating to the devices for which they have been designated. 

Notified  bodies  shall  respond  without  delay  to  requests  relating  to  conformity 
assessments  they  have  carried  out,  submitted  by  their  or  another  Member  State's 
authority  or  by  the  Commission.  The  national  authority  responsible  for  notified 
bodies of the Member State in which the body is established shall enforce requests 
submitted  by  authorities  of  any  other  Member  State  or  by  the  Commission  unless 
there is a legitimate reason for not doing so in which case both sides may consult the 
MDCG. The notified body or their national authority responsible for notified bodies 
may  request  that  any  information  transmitted  to  the  authorities  of  another  Member 
State or to the Commission shall be treated confidential. 

At least once a year, the national authority responsible for notified bodies shall assess 
whether each notified body under its responsibility still satisfies the requirements set 
out in Annex VI. This assessment shall include an on-site visit to each notified body.  

Three  years  after  notification  of  a  notified  body,  and  again  every  third  year 
thereafter,  the  assessment  to  determine  whether  the  notified  body  still  satisfies  the 
requirements  set  out  in  Annex  VI  shall  be  conducted  by  the  national  authority 
responsible for notified bodies of the Member State in which the body is established 
and a joint assessment team designated in accordance with the procedure described 
in Article 32(3) and (4). At the request of the Commission or of a Member State, the 
MDCG may initiate the assessment process described in this paragraph at any time 
when  there  is  reasonable  concern  about  the  ongoing  compliance  of  a  notified  body 
with the requirements set out in Annex VI. 

The Member States shall report to the Commission and to the other Member States, 
at  least  once  a  year,  on  their  monitoring  activities.  This  report  shall  contain  a 
summary which shall be made publicly available. 

Article 36 
Changes to notifications 

The  Commission  and  the  other  Member  States  shall  be  notified  of  any  subsequent 
relevant changes to the notification. The procedures described in Article 32(2) to (6) 
and in Article 33 shall apply to changes where they entail an extension of the scope 
of the notification. In all other cases, the Commission shall immediately publish the 
amended notification in the electronic notification tool referred to in Article 33(10). 

Where  a  national  authority  responsible  for  notified  bodies  has  ascertained  that  a 
notified  body  no  longer  meets  the  requirements  set  out  in  Annex  VI,  or  that  it  is 
failing  to  fulfil  its  obligations,  the  authority  shall  suspend,  restrict,  or  fully  or 
partially  withdraw  the  notification,  depending  on  the  seriousness  of  the  failure  to 
meet those requirements or fulfil those obligations. A suspension shall not exceed a 
period of one year, renewable once for the same period. Where the notified body has 

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3. 

4. 

ceased  its  activity,  the  national  authority  responsible  for  notified  bodies  shall 
withdraw the notification.  

The  national  authority  responsible  for  notified  bodies  shall  immediately  inform  the 
Commission  and  the  other  Member  States  of  any  suspension,  restriction  or 
withdrawal of a notification. 

In  the  event  of  restriction,  suspension  or  withdrawal  of  a  notification,  the  Member 
State  shall  take  appropriate  steps  to  ensure  that  the  files  of  the  notified  body 
concerned  are  either  processed  by  another  notified  body  or  kept  available  for  the 
national  authorities  responsible  for  notified  bodies  and  for  market  surveillance  at 
their request.  

The  national  authority  responsible  for  notified  bodies  shall  assess  whether  the 
reasons  which  gave  rise  to  the  change  to  the  notification  have  an  impact  on  the 
certificates issued by the notified body and, within three months after having notified 
the  changes  to  the  notification,  shall  submit  a  report  on  its  findings  to  the 
Commission and the other Member States. Where necessary to ensure the safety of 
devices  on  the  market,  that  authority  shall  instruct  the  notified  body  to  suspend  or 
withdraw,  within  a  reasonable  period  of  time  determined  by  the  authority,  any 
certificates which were unduly issued. If the notified body fails to do so within the 
determined  period  of  time,  or  has  ceased  its  activity,  the  national  authority 
responsible  for  notified  bodies  itself  shall  suspend  or  withdraw  the  certificates 
unduly issued. 

5. 

The  certificates,  other  than  those  unduly  issued,  which  were  issued  by  the  notified 
body  for  which  the  notification  has  been  suspended,  restricted  or  withdrawn  shall 
remain valid in the following circumstances: 

(a) 

(b) 

in  the  case  of  suspension  of  a  notification:  on  condition  that,  within  three 
months of the suspension, either the competent authority for medical devices of 
the  Member  State  in  which  the  manufacturer  of  the  device  covered  by  the 
certificate is established, or another notified body confirm in writing that it is 
assuming the functions of the notified body during the period of suspension; 

in the case of restriction or withdrawal of a notification: for a period of three 
months after the restriction or withdrawal. The competent authority for medical 
devices of the Member State in which the manufacturer of the device covered 
by  the  certificate  is  established  may  extend  the  validity  of  the  certificates  for 
further  periods  of  three  months,  which  altogether  may  not  exceed  twelve 
months, provided it is assuming the functions of the notified body during this 
period. 

The  authority  or  the  notified  body  assuming  the  functions  of  the  notified  body 
affected by the change of notification shall immediately inform the Commission, the 
other Member States and the other notified bodies thereof. 

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Article 37 
Challenge to the competence of notified bodies 

1. 

2. 

3. 

The Commission shall investigate all cases where concerns have been brought to its 
attention  regarding  the  continued  fulfilment  by  a  notified  body  of  the  requirements 
set out in Annex VI or the obligations to which it is subject. It may also commence 
such investigations on its own initiative.  

The  notifying  Member  State  shall  provide  the  Commission,  on  request,  with  all 
information regarding the notification of the notified body concerned.  

Where  the  Commission  ascertains  that  a  notified  body  no  longer  meets  the 
requirements  for  its  notification,  it  shall  inform  the  notifying  Member  State 
accordingly  and  request  it  to  take  the  necessary  corrective  measures,  including  the 
suspension, restriction or withdrawal of the notification if necessary.  

Where  the  Member  State  fails  to  take  the  necessary  corrective  measures,  the 
Commission may, by means of implementing acts, suspend, restrict or withdraw the 
notification.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
examination procedure referred to in Article 88(3). It shall notify the Member State 
concerned of its decision and update the database and list of notified bodies.  

Article 38 
Exchange of experience between national authorities responsible for notified bodies 

The  Commission  shall  provide  for  the  organisation  of  exchange  of  experience  and 
coordination  of  administrative  practice  between  the  national  authorities  responsible  for 
notified bodies under this Regulation. 

Article 39 
Coordination of notified bodies 

The Commission shall ensure that appropriate coordination and cooperation between notified 
bodies is put in place and operated in the form of a coordination group of notified bodies in 
the field of medical devices, including in vitro diagnostic medical devices. 

The bodies notified under this Regulation shall participate in the work of that group. 

Article 40 
Fees 

1. 

2. 

The  Member  State  where  the  bodies  are  established  shall  levy  fees  on  applicant 
conformity  assessment  bodies  and  on  notified  bodies.  These  fees  shall,  wholly  or 
partly, cover the costs relating to the activities exercised by the national authorities 
responsible for notified bodies in accordance with this Regulation. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 89 setting out the structure and the level of the fees referred to in paragraph 1, 
taking into account the objectives of protection of human health and safety, support 

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of innovation and cost-effectiveness. Particular attention shall be paid to the interests 
of  notified  bodies  that  submitted  a  valid  certificate  delivered  by  the  national 
accreditation body as referred to in Article 31(2) and notified bodies that are small 
and  medium-sized  enterprises  as  defined  by  Commission  Recommendation 
2003/361/EC.  

Chapter V 
Classification and conformity assessment 

SECTION 1 – CLASSIFICATION 

Article 41 
Classification of medical devices 

1. 

2. 

3. 

4. 

Devices  shall  be  divided  into  classes  I,  IIa,  IIb  and  III,  taking  into  account  their 
intended purpose and inherent risks. Classification shall be carried out in accordance 
with the classification criteria set out in Annex VII.  

Any dispute between the manufacturer and the notified body concerned, arising from 
the  application  of  the  classification  criteria,  shall  be  referred  for  a  decision  to  the 
competent authority of the Member State where the manufacturer has his registered 
place  of  business.  In  cases  where  the  manufacturer  has  no  registered  place  of 
business  in  the  Union  and  has  not  yet  designated  an  authorised  representative,  the 
matter  shall  be  referred  to  the  competent  authority  of  the  Member  State  where  the 
authorised representative referred to in the last indent of point (b) of Section 3.2. of 
Annex VIII has his registered place of business.  

At  least  14  days  prior  to  any  decision,  the  competent  authority  shall  notify  the 
MDCG and the Commission of its envisaged decision. 

The Commission may, at the request of a Member State or on its own initiative, by 
means  of  implementing  acts,  decide  on  the  application  of  the  classification  criteria 
set out in Annex VII to a given device, or category or group of devices, with a view 
to determining their classification.  

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 88(3). 

In the light of technical progress and any information which becomes available in the 
course of the vigilance and market surveillance activities described in Articles 61 to 
75, the Commission shall be empowered to adopt delegated acts in accordance with 
Article 89 as regards the following:  

(a)  deciding  that  a  device,  or  category  or  group  of  devices,  should,  by  way  of 
derogation from the classification criteria set out in Annex VII, be classified in 
another class;  

(b) 

amending or supplementing the classification criteria set out in Annex VII. 

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SECTION 2 – CONFORMITY ASSESSMENT 

Article 42 
Conformity assessment procedures 

1. 

2. 

3. 

4. 

5. 

Prior to placing a device on the market, manufacturers shall undertake an assessment 
of the conformity of that device. The conformity assessment procedures are set out in 
Annexes VIII to XI. 

Manufacturers  of  devices  classified  as  class  III,  other  than  custom-made  or 
investigational  devices,  shall  be  subject  to  a  conformity  assessment  based  on  full 
quality  assurance  and  design  dossier  examination  as  specified  in  Annex  VIII. 
Alternatively, the manufacturer may choose to apply a conformity assessment based 
on type examination as specified in Annex IX coupled with a conformity assessment 
based on product conformity verification as specified in Annex X.  

In the case of devices referred to in the first subparagraph of Article 1(4), the notified 
body shall follow the consultation procedure as specified in Section 6.1 of Chapter II 
of Annex VIII or Section 6 of Annex IX, as applicable. 

In the case of devices that are covered by this Regulation in accordance with point 
(e)  of  Article  1(2),  the  notified  body  shall  follow  the  consultation  procedure  as 
specified  in  Section  6.2  of  Chapter  II  of  Annex  VIII  or  Section  6  of  Annex  IX,  as 
applicable. 

Manufacturers  of  devices  classified  as  class  IIb,  other  than  custom-made  or 
investigational  devices,  shall  be  subject  to  a  conformity  assessment  based  on  full 
quality  assurance  as  specified  in  Annex  VIII,  except  for  its  Chapter  II,  with 
assessment  of  the  design  documentation  within  the  technical  documentation  on  a 
representative  basis.  Alternatively,  the  manufacturer  may  choose  to  apply  a 
conformity assessment based on type examination as specified in Annex IX coupled 
with a conformity assessment based on product conformity verification as specified 
in Annex X. 

Manufacturers  of  devices  classified  as  class  IIa,  other  than  custom-made  or 
investigational  devices,  shall  be  subject  to  a  conformity  assessment  based  on  full 
quality  assurance  as  specified  in  Annex  VIII,  except  for  its  Chapter  II,  with 
assessment  of  the  design  documentation  within  the  technical  documentation  on  a 
representative  basis.  Alternatively,  the  manufacturer  may  choose  to  draw  up  the 
technical  documentation  set  out  in  Annex  II  coupled  with  a  conformity  assessment 
based  on  product  conformity  verification  as  specified  in  Section  7  of  Part  A  or 
Section 8 of Part B of Annex X. 

Manufacturers  of  devices  classified  as  class  I,  other  than  custom-made  or 
investigational devices, shall declare the conformity of their products by issuing the 
EU declaration of conformity referred to in Article 17 after drawing up the technical 
documentation set out in Annex II. If the devices are placed on the market in sterile 
condition or have a measuring function, the manufacturer shall apply the procedures 

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6. 

7. 

8. 

9. 

10. 

set out in Annex VIII, except for its Chapter II, or in Part A of Annex X. However, 
involvement of the notified body shall be limited:  

(a) 

(b) 

in the case of devices placed on the market in sterile condition, to the aspects of 
manufacture concerned with securing and maintaining sterile conditions, 

in the case of devices with a measuring function, to the aspects of manufacture 
concerned  with  the  conformity  of  the  devices  with  the  metrological 
requirements. 

Manufacturers may choose to apply a conformity assessment procedure applicable to 
devices of a higher class than the device in question. 

Manufacturers of custom-made devices shall follow the procedure set out in Annex 
XI and draw up the statement set out in that Annex before placing the device on the 
market. 

The Member State in which the notified body is established may determine that all or 
certain  documents,  including  the  technical  documentation,  audit,  assessment  and 
inspection reports, relating to the procedures referred to in paragraphs 1 to 6 shall be 
available  in  an  official  Union  language.  Otherwise  they  shall  be  available  in  an 
official Union language acceptable to the notified body.  

Investigational devices shall be subject to the requirements set out in Articles 50 to 
60. 

The  Commission  may,  by  means  of  implementing  acts,  specify  the  modalities  and 
the  procedural  aspects  with  a  view  to  ensuring  harmonised  application  of  the 
conformity  assessment  procedures  by  the  notified  bodies  for  any  of  the  following 
aspects:  

– 

– 

– 

the  frequency  and  the  sampling  basis  of  the  assessment  of  the  design 
documentation within the technical documentation on a representative basis as 
set  out  in  Sections  3.3(c)  and  4.5  of  Annex  VIII  in  the  case  of  devices  of 
classes  IIa  and  IIb,  and  in  Section  7.2  of  Part  A  of  Annex  X  in  the  case  of 
devices of class IIa;  

the minimum frequency of unannounced factory inspections and sample checks 
to  be  conducted  by  notified  bodies  in  accordance  with  Section  4.4  of  Annex 
VIII, taking into account the risk-class and the type of device; 

the physical, laboratory or other tests to be carried out by notified bodies in the 
context of sample checks, design dossier examination and type examination in 
accordance  with  Sections  4.4  and  5.3  of  Annex  VIII,  Section  3  of  Annex  IX 
and Section 5 of Part B of Annex X. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 88(3). 

11. 

In the light of technical progress and any information which becomes available in the 
course of the designation or monitoring of notified bodies set out in Articles 28 to 40, 
or of the vigilance and market surveillance activities described in Articles 61 to 75, 

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1. 

2. 

3. 

4. 

1. 

2. 

the  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 89 amending or supplementing the conformity assessment procedures set out 
in Annexes VIII to XI. 

Article 43 
Involvement of notified bodies 

Where  the  conformity  assessment  procedure  requires  the  involvement  of  a  notified 
body, the manufacturer may apply to a notified body of his choice, provided that the 
body is notified for the conformity assessment activities, the conformity assessment 
procedures and the devices concerned. An application may not be lodged in parallel 
with more than one notified body for the same conformity assessment activity.  

The  notified  body  concerned  shall  inform  the  other  notified  bodies  of  any 
manufacturer  who  withdraws  his  application  prior  to  the  notified  body's  decision 
regarding the conformity assessment.  

The notified body may require any information or data from the manufacturer which 
is  necessary  in  order  to  properly  conduct  the  chosen  conformity  assessment 
procedure. 

Notified bodies and the personnel of notified bodies shall carry out their conformity 
assessment  activities  with  the  highest  degree  of  professional  integrity  and  the 
requisite  technical  competence  in  the  specific  field  and  shall  be  free  from  all 
pressures  and  inducements,  particularly  financial,  which  might  influence  their 
judgement  or  the  results  of  their  conformity  assessment  activities,  especially  as 
regards persons or groups with an interest in the results of those activities.  

Article 44 
Mechanism for scrutiny of certain conformity assessments 

Notified  bodies  shall  notify  the  Commission  of  applications  for  conformity 
assessments for devices classified as class III, with the exception of applications to 
supplement or renew existing certificates. The notification shall be accompanied by 
the  draft  instructions  for  use  referred  to  in  Section  19.3  of  Annex  I  and  the  draft 
summary  of  safety  and  clinical  performance  referred  to  in  Article  26.  In  its 
notification  the  notified  body  shall  indicate  the  estimated  date  by  which  the 
conformity  assessment  is  to  be  completed.  The  Commission  shall  immediately 
transmit the notification and the accompanying documents to the MDCG.  

Within 28 days of receipt of the information referred to in paragraph 1, the MDCG 
may  request  the  notified  body  to  submit  a  summary  of  the  preliminary  conformity 
assessment prior to issuing a certificate. Upon suggestion by any of its members or 
by the Commission, the MDCG shall decide on making such request in accordance 
with  the  procedure  set  out  in  Article  78(4).  In  its  request  the  MDCG  shall  indicate 
the  scientifically  valid  health  reason  for  having  selected  the  specific  file  for 
submission of a summary of the preliminary conformity assessment. When selecting 
a specific file for submission, the principle of equal treatment shall be duly taken into 
account.  

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3. 

4. 

5. 

Within  5  days  after  receipt  of  the  request  by  the  MDCG,  the  notified  body  shall 
inform the manufacturer thereof.  

The  MDCG  may  submit  comments  on  the  summary  of  the  preliminary  conformity 
assessment at the latest 60 days after submission of this summary. Within that period 
and at the latest 30 days after submission, the MDCG may request the submission of 
additional  information  that  for  scientifically  valid  grounds  are  necessary  for  the 
analysis of the notified body's preliminary conformity assessment. This may include 
a  request  for  samples  or  an  on-site  visit  to  the  manufacturer's  premises.  Until 
submission of the additional information requested, the period for comments referred 
to in the first sentence of this subparagraph shall be suspended. Subsequent requests 
for  additional  information  from  the  MDCG  shall  not  suspend  the  period  for  the 
submission of comments. 

The  notified  body  shall  give  due  consideration  to  any  comments  received  in 
accordance  with  paragraph  3.  It  shall  convey  to  the  Commission  an  explanation  of 
how they have been taken into consideration, including any due justification for not 
following  the  comments  received,  and  its  final  decision  regarding  the  conformity 
assessment in question. The Commission shall immediately transmit this information 
to the MDCG.  

Where  deemed  necessary  for  the  protection  of  patient  safety  and  public  health,  the 
Commission, may determine, by means of implementing acts, specific categories or 
groups  of  devices,  other  than  devices  of  class  III,  to  which  paragraphs  1  to  4  shall 
apply during a predefined period of time. Those implementing acts shall be adopted 
in accordance with the examination procedure referred to in Article 88(3). 

Measures  pursuant  to  this  paragraph  may  be  justified  only  by  one  or  more  of  the 
following criteria: 

(a) 

(b) 

(c) 

(d) 

the  novelty  of  the  device  or  of  the  technology  on  which  it  is  based  and  the 
significant clinical or public health impact thereof; 

an adverse change in the risk-benefit profile of a specific category or group of 
devices due to scientifically valid health concerns in respect of components or 
source material or in respect of the impact on health in case of failure;  

an increased rate of serious incidents reported in accordance with Article 61 in 
respect of a specific category or group of devices; 

significant discrepancies in the conformity assessments carried out by different 
notified bodies on substantially similar devices;  

(e)  public health concerns regarding a specific category or group of devices or the 

technology on which they are based. 

6. 

The  Commission  shall  make  a  summary  of  the  comments  submitted  in  accordance 
with paragraph 3 and the outcome of the conformity assessment procedure accessible 
to the public. It shall not disclose any personal data or information of commercially 
confidential nature. 

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7. 

8. 

1. 

2. 

3. 

4. 

5. 

1. 

The Commission shall set up the technical infrastructure for the data-exchange by an 
electronic means between notified bodies and MDCG for the purposes of this Article.  

The Commission, by means of implementing acts, may adopt the modalities and the 
procedural  aspects  concerning  the  submission  and  analysis  of  the  summary  of  the 
preliminary  conformity  assessment  in  accordance  with  paragraphs  2  and  3.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 88(3).  

Article 45 
Certificates 

The  certificates  issued  by  the  notified  bodies  in  accordance  with  Annexes  VIII,  IX 
and  X  shall  be  in  an  official  Union  language  determined  by  the  Member  State  in 
which  the  notified  body  is  established  or  otherwise  in  an  official  Union  language 
acceptable to the notified body. The minimum content of the certificates is set out in 
Annex XII.  

The  certificates  shall  be  valid  for  the  period  they  indicate,  which  shall  not  exceed 
five years. On application by the manufacturer, the validity of the certificate may be 
extended for further periods, each not exceeding five years, based on a re-assessment 
in  accordance  with 
the  applicable  conformity  assessment  procedures.  Any 
supplement  to  a  certificate  shall  remain  valid  as  long  as  the  certificate  which  it 
supplements is valid. 

Where a notified body finds that requirements of this Regulation are no longer met 
by  the  manufacturer,  it  shall,  taking  account  of  the  principle  of  proportionality, 
suspend  or  withdraw  the  certificate  issued  or  impose  any  restrictions  on  it  unless 
compliance with such requirements is ensured by appropriate corrective action taken 
by  the  manufacturer  within  an  appropriate  deadline  set  by  the  notified  body.  The 
notified body shall give the reasons for its decision. 

The Commission, in collaboration with the Member States, shall set up and manage 
an  electronic  system  to  collate  and  process  information  on  certificates  issued  by 
notified bodies. The notified body shall enter into this electronic system information 
regarding certificates issued, including amendments and supplements, and regarding 
suspended, reinstated, withdrawn or refused certificates and restrictions imposed on 
certificates. This information shall be accessible to the public. 

In  the  light  of  technical  progress,  the  Commission  shall  be  empowered  to  adopt 
delegated  acts  in  accordance  with  Article  89  amending  or  supplementing  the 
minimum content of the certificates set out in Annex XII.  

Article 46 
Voluntary change of notified body 

In cases where a manufacturer terminates his contract with a notified body and enters 
into a contract with another notified body in respect of the conformity assessment of 
the  same  device,  the  modalities  of  the  change  of  notified  body  shall  be  clearly 
defined  in  an  agreement  between  the  manufacturer,  the  outgoing  notified  body  and 

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the  incoming  notified  body.  This  agreement  shall  address  at  least  the  following 
aspects:  

(a) 

the date of invalidity of certificates issued by the outgoing notified body; 

(b) 

the  date  until  which  the  identification  number  of  the  outgoing  notified  body 
may  be  indicated  in  the  information  supplied  by  the  manufacturer,  including 
any promotional material;  

(c) 

the transfer of documents, including confidentiality aspects and property rights; 

(d) 

the date as of which the incoming notified body assumes full responsibility for 
the conformity assessment tasks. 

On their date of invalidity, the outgoing notified body shall withdraw the certificates 
it has issued for the device concerned. 

Article 47 
Derogation from the conformity assessment procedures 

By  way  of  derogation  from  Article  42,  any  competent  authority  may  authorise,  on 
duly  justified  request,  the  placing  on  the  market  or  putting  into  service  within  the 
territory  of  the  Member  State  concerned,  of  a  specific  device  for  which  the 
procedures referred to in Article 42 have not been carried out and use of which is in 
the interest of public health or patient safety.  

The Member State shall inform the Commission and the other Member States of any 
decision to authorise the placing on the market or putting into service of a device in 
accordance with paragraph 1 where such authorisation is granted for use other than 
for a single patient. 

Upon request by a Member State and where this is in the interest of public health or 
patient  safety  in  more  than  one  Member  State,  the  Commission  may,  by  means  of 
implementing  acts,  extend  for  a  determined  period  of  time  the  validity  of  an 
authorisation  granted  by  a  Member  State  in  accordance  with  paragraph  1  to  the 
territory of the Union and set the conditions under which the device may be placed 
on  the  market  or  put  into  service.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 88(3). 

On duly justified imperative grounds of urgency relating to the health and safety of 
humans,  the  Commission  shall  adopt  immediately  applicable  implementing  acts  in 
accordance with the procedure referred to in Article 88(4). 

2. 

1. 

2. 

3. 

Article 48 
Certificate of free sale 

1. 

For the purpose of export and upon request by a manufacturer, the Member State in 
which the manufacturer has its registered place of business shall issue a certificate of 
free sale declaring that the manufacturer is properly established and that the device in 
question bearing the CE-marking in accordance with this Regulation may be legally 

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2. 

1. 

2. 

3. 

marketed  in  the  Union.  The  certificate  of  free  sale  shall  be  valid  for  the  period 
indicated on it which shall not exceed five years and shall not exceed the validity of 
the certificate referred to in Article 45 issued for the device in question.  

The  Commission  may,  by  means  of  implementing  acts,  establish  a  model  for 
certificates of free sale taking into account international practice as regards the use of 
certificates of free sale. Those implementing acts shall be adopted in accordance with 
the advisory procedure referred to in Article 88(2). 

Chapter VI 
Clinical evaluation and clinical investigations  

Article 49 
Clinical evaluation  

Manufacturers  shall  conduct  a  clinical  evaluation  in  accordance  with  the  principles 
set out in this Article and Part A of Annex XIII.  

A  clinical  evaluation  shall  follow  a  defined  and  methodologically  sound  procedure 
based on either of the following: 

(a) 

a  critical  evaluation  of  the  relevant  scientific  literature  currently  available 
relating to the safety, performance, design characteristics and intended purpose 
of the device, where the following conditions are satisfied: 

– 

– 

it  is  demonstrated  that  the  device  subject  to  clinical  evaluation  and  the 
device to which the data relate are equivalent,  

the  data  adequately  demonstrate  compliance  with  the  relevant  general 
safety and performance requirements; 

a  critical  evaluation  of  the  results  of  all  clinical  investigations  performed  in 
accordance with Articles 50 to 60 and Annex XIV; 

a critical evaluation of the combined clinical data referred to in points (a) and 
(b). 

(b) 

(c) 

Where  demonstration  of  conformity  with  general  safety  and  performance 
requirements based on clinical data is not deemed appropriate, adequate justification 
for any such exception shall be given based on the results of the manufacturer's risk 
management  and  on  consideration  of  the  specifics  of  the  interaction  between  the 
device and the human body, the clinical performances intended and the claims of the 
manufacturer. The adequacy of demonstration of conformity with the general safety 
and  performance  requirements  based  on  the  results  of  non-clinical  testing  methods 
alone,  including  performance  evaluation,  bench  testing  and  pre-clinical  evaluation, 
has to be duly substantiated in the technical documentation referred to in Annex II. 

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4. 

5. 

The  clinical  evaluation  and  its  documentation  shall  be  updated  throughout  the  life 
cycle  of  the  device  concerned  with  data  obtained  from  the  implementation  of  the 
manufacturer's post-market surveillance plan referred to in Article 8(6). 

The clinical evaluation and its outcome shall be documented in a clinical evaluation 
report  referred  to  in  Section  6  of  Part  A  of  Annex  XIII  which  shall  be  included  or 
fully referenced in the technical documentation referred to in Annex II relating to the 
device concerned. 

Article 50 
General requirements regarding clinical investigations 

1. 

Clinical investigations shall be subject to Articles 50-60 and Annex XIV if they are 
conducted for one or more of the following purposes:  

(a) 

(b) 

(c) 

to  verify  that,  under  normal  conditions  of  use,  devices  are  designed, 
manufactured  and  packaged  in  such  a  way  that  they  are  suitable  for  one  or 
more of the specific purposes of a medical device referred to in number (1) of 
Article  2(1),  and  achieve  the  performances  intended  as  specified  by  the 
manufacturer; 

to verify that devices achieve the intended benefits to the patient as specified 
by the manufacturer; 

to determine any undesirable side-effects, under normal conditions of use, and 
assess  whether  they  constitute  acceptable  risks  when  weighed  against  the 
benefits to be achieved by the device.  

2. 

3. 

4. 

1. 

Where  the  sponsor  is  not  established  in  the  Union,  he  shall  ensure  that  a  contact 
person is established in the Union. That contact person shall be the addressee for all 
this  Regulation.  Any 
communications  with 
communication  to  that  contact  person  shall  be  considered  as  communication  to  the 
sponsor. 

the  sponsor  provided  for 

in 

Clinical  investigations  shall  be  designed  and  conducted  in  a  way  that  the  rights, 
safety  and  well-being  of  the  subjects  participating  in  a  clinical  investigation  are 
protected and that the clinical data generated in the clinical investigation are going to 
be reliable and robust.  

Clinical  investigations  shall  be  designed,  conducted,  recorded  and  reported  in 
accordance with the provisions of Articles 50 to 60 and of Annex XIV.  

Article 51 
Application for clinical investigations 

Before  making  the  first  application,  the  sponsor  shall  procure  from  the  electronic 
system  referred  to  in  Article  53  a  single  identification  number  for  a  clinical 
investigation conducted in one site or multiple sites, in one or more than one Member 
State.  The  sponsor  shall  use  this  single  identification  number  when  registering  the 
clinical investigation in accordance with Article 52. 

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2. 

3. 

4. 

The  sponsor  of  a  clinical  investigation  shall  submit  an  application  to  the  Member 
State(s)  in  which  the  investigation  is  to  be  conducted  accompanied  by  the 
documentation referred to in Chapter II of Annex XIV. Within six days after receipt 
of the application, the Member State concerned shall notify the sponsor whether the 
clinical  investigation  falls  within  the  scope  of  this  Regulation  and  whether  the 
application is complete.  

Where the Member State has not notified the sponsor within the time period referred 
to  in  the  first  subparagraph,  the  clinical  investigation  shall  be  considered  as  falling 
within the scope of this Regulation and the application shall be considered complete. 

Where the Member State finds that the clinical investigation applied for does not fall 
within  the  scope  of  this  Regulation  or  that  the  application  is  not  complete,  it  shall 
inform  the  sponsor  thereof  and  shall  set  a  maximum  of  six  days  for  the  sponsor  to 
comment or to complete the application.  

Where the sponsor has not provided comments nor completed the application within 
the  time-period  referred  to  in  the  first  subparagraph,  the  application  shall  be 
considered as withdrawn.  

Where  the  Member  State  has  not  notified  the  sponsor  according  to  paragraph  2 
within three days following receipt of the comments or of the completed application, 
the  clinical  investigation  shall  be  considered  as  falling  within  the  scope  of  this 
Regulation and the application shall be considered complete. 

For  the  purposes  of  this  Chapter,  the  date  on  which  the  sponsor  is  notified  in 
accordance  with  paragraph  2  shall  be  the  validation  date  of  the  application.  Where 
the sponsor is not notified, the validation date shall be the last day of the time periods 
referred to in paragraphs 2 and 3. 

5. 

The sponsor may start the clinical investigation in the following circumstances:  

(a) 

(b) 

(c) 

in the case of investigational devices classified as class III and implantable or 
long-term invasive devices classified as class IIa or IIb, as soon as the Member 
State concerned has notified the sponsor of its approval; 

in  the  case  of  investigational  devices  other  than  those  referred  to  in  point  (a) 
immediately  after  the  date  of  application  provided  that  the  Member  State 
concerned has so decided and that evidence is provided that the rights, safety 
and well-being of the subjects to the clinical investigation are protected; 

after the expiry of 35 days after the validation date referred to in paragraph 4, 
unless the Member State concerned has notified the sponsor within that period 
of its refusal based on considerations of public health, patient safety or public 
policy.  

6. 

Member  States  shall  ensure  that  the  persons  assessing  the  application  do  not  have 
conflicts of interest and that they are independent of the sponsor, the institution of the 
investigation site(s) and the investigators involved, as well as free of any other undue 
influence.  

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7. 

1. 

2. 

3. 

Member  States  shall  ensure  that  the  assessment  is  done  jointly  by  a  reasonable 
number  of  persons  who  collectively  have  the  necessary  qualifications  and 
experience. In the assessment, the view of at least one person whose primary area of 
interest is non-scientific shall be taken into account. The view of at least one patient 
shall be taken into account. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 89 amending or supplementing, in the light of technical progress and global 
regulatory  developments,  the  requirements  for  the  documentation  to  be  submitted 
with  the  application  for  the  clinical  investigation  that  is  laid  down  in  Chapter  II  of 
Annex XIV. 

Article 52  
Registration of clinical investigations 

Before  commencing  the  clinical  investigation,  the  sponsor  shall  enter  in  the 
electronic  system  referred  to  in  Article  53  the  following  information  regarding  the 
clinical investigation:  

(a) 

the single identification number of the clinical investigation; 

(b) 

(c) 

the  name  and  contact  details  of  the  sponsor  and,  if  applicable,  his  contact 
person established in the Union; 

the name and contact details of the natural or legal person responsible for the 
manufacture of the investigational device, if different from the sponsor; 

(d) 

the description of the investigational device; 

(e) 

the description of the comparator(s), if applicable; 

(f) 

the purpose of the clinical investigation; 

(g) 

the status of the clinical investigation.  

Within one week of any change occurring in relation to the information referred to in 
paragraph  1,  the  sponsor  shall  update  the  relevant  data  in  the  electronic  system 
referred to in Article 53. 

The  information  shall  be  accessible  to  the  public,  through  the  electronic  system 
referred to in Article 53, unless, for all or parts of that information, confidentiality of 
the information is justified on any of the following grounds: 

(a)  protection of personal data in accordance with Regulation (EC) No 45/2001; 

(b)  protection of commercially sensitive information; 

(c) 

effective supervision of the conduct of the clinical investigation by the Member 
State(s) concerned. 

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4. 

1. 

2. 

3. 

1. 

No personal data of subjects participating in clinical investigations shall be publicly 
available. 

Article 53 
Electronic system on clinical investigations 

The Commission shall, in collaboration with the Member States, set up and manage 
an  electronic  system  to  create  the  single  identification  numbers  for  clinical 
investigations  referred  to  in  Article  51(1)  and  to  collate  and  process  the  following 
information:  

(a) 

the registration of clinical investigations in accordance with Article 52; 

(b) 

(c) 

(d) 

the exchange of information between the Member States and between them and 
the Commission in accordance with Article 56; 

the  information  related  to  clinical  investigations  conducted  in  more  than  one 
Member State in case of a single application in accordance with Article 58; 

reports on serious adverse events and device deficiencies referred to in Article 
59(2) in case of a single application in accordance with Article 58.  

When setting up the electronic system referred in paragraph 1, the Commission shall 
ensure  that  it  is  interoperable  with  the  EU  database  for  clinical  trials  on  medicinal 
products for human use set up in accordance with Article […] of Regulation (EU) No 
[…/…].  With  the  exception  of  the  information  referred  to  in  Article  52,  the 
information collated and processed in the electronic system shall be accessible only 
to the Member States and to the Commission.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  89  determining  which  other  information  regarding  clinical  investigations 
collated and processed in the electronic system shall be publicly accessible to allow 
interoperability  with  the  EU  database  for  clinical  trials  on  medicinal  products  for 
human use set up by Regulation (EU) No […/…]. Article 52(3) and (4) shall apply. 

Article 54 
Clinical investigations with devices authorised to bear the CE marking 

Where a clinical investigation is to be conducted to further assess a device which is 
authorised  in  accordance  with  Article  42  to  bear  the  CE  marking  and  within  its 
intended  purpose  referred  to  in  the  relevant  conformity  assessment  procedure, 
hereinafter referred to as ‘post-market clinical follow-up investigation’, the sponsor 
shall  notify  the  Member  States  concerned  at  least  30  days  prior  to  their 
commencement if the investigation would submit subjects to additionally invasive or 
burdensome  procedures.  Article  50(1)  to  (3),  Article  52,  Article  55,  Article  56(1), 
Article 57(1), the first subparagraph of Article 57(2) and the relevant provisions of 
Annex XIV shall apply.  

2. 

If  the  aim  of  the  clinical  investigation  regarding  a  device  which  is  authorised  in 
accordance  with  Article  42  to  bear  the  CE  marking  is  to  assess  such  device  for  a 

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1. 

2. 

1. 

2. 

1. 

2. 

purpose other than that referred to in the information supplied by the manufacturer in 
accordance  with  Section  19  of  Annex  I  and  in  the  relevant  conformity  assessment 
procedure, Articles 50 to 60 shall apply. 

Article 55 
Substantial modifications to a clinical investigation 

If  the  sponsor  introduces  modifications  to  a  clinical  investigation  that  are  likely  to 
have a substantial impact on the safety or rights of the subjects or on the robustness 
or  reliability  of  the  clinical  data  generated  by  the  investigation,  he  shall  notify  the 
Member State(s) concerned of the reasons for and the content of those modifications. 
The  notification  shall  be  accompanied  by  an  updated  version  of  the  relevant 
documentation referred to in Chapter II of Annex XIV. 

The  sponsor  may  implement  the  modifications  referred  to  in  paragraph  1  at  the 
earliest  30  days  after  notification,  unless  the  Member  State  concerned  has  notified 
the sponsor of its refusal based on considerations of public health, patient safety or 
public policy. 

Article 56 
Information exchange between Member States 

Where a Member State has refused, suspended or terminated a clinical investigation, 
or  has  called  for  a  substantial  modification  or  temporary  halt  of  a  clinical 
investigation,  or  has  been  notified  by  the  sponsor  of  the  early  termination  of  a 
clinical  investigation  on  safety  grounds,  that  Member  State  shall  communicate  its 
decision  and  the  grounds  therefor  to  all  Member  States  and  the  Commission  by 
means of the electronic system referred to in Article 53. 

Where an application is withdrawn by the sponsor prior to a decision by a Member 
State,  that  Member  State  shall  inform  all  the  other  Member  States  and  the 
Commission of that fact, by means of the electronic system referred to in Article 53.  

Article 57 
Information by the sponsor in the event of temporary halt or termination of a clinical 
investigation 

If  the  sponsor  has  temporarily  halted  a  clinical  investigation  on  safety  grounds,  he 
shall inform the Member States concerned within 15 days of the temporary halt. 

The  sponsor  shall  notify  each  Member  State  concerned  of  the  end  of  a  clinical 
investigation in relation to that Member State, providing a justification in the event 
of early termination. That notification shall be made within 15 days from the end of 
the clinical investigation in relation to that Member State. 

If  the  investigation  is  conducted  in  more  than  one  Member  State  the  sponsor  shall 
notify  all  Member  States  concerned  of  the  overall  end  of  the  clinical  investigation. 
That  notification  shall  be  made  within  15  days  from  the  overall  end  of  the  clinical 
investigation. 

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3. 

1. 

2. 

3. 

Within one year from the end of the clinical investigation, the sponsor shall submit to 
the Member States concerned a summary of the results of the clinical investigation in 
form  of  a  clinical  investigation  report  referred  to  in  Section  2.7  of  Chapter  I  of 
Annex  XIV.  Where,  for  scientific  reasons,  it  is  not  possible  to  submit  the  clinical 
investigation report within one year, it shall be submitted as soon as it is available. In 
this  case,  the  clinical  investigation  plan  referred  to  in  Section  3  of  Chapter  II  of 
Annex XIV shall specify when the results of the clinical investigation are going to be 
submitted, together with an explanation.  

Article 58 
Clinical investigations conducted in more than one Member State 

By means of the electronic system referred to in Article 53, the sponsor of a clinical 
investigation  to  be  conducted  in  more  than  one  Member  State  may  submit,  for  the 
purpose  of  Article  51,  a  single  application  that,  upon  receipt,  is  transmitted 
electronically to the Member States concerned.  

In  the  single  application,  the  sponsor  shall  propose  one  of  the  Member  States 
concerned as coordinating Member State. If that Member State does not wish to be 
the coordinating Member State, it shall  agree, within six days of submission of the 
single application, with another Member State concerned that the latter shall be the 
coordinating Member State. If no other Member State accepts to be the coordinating 
Member State, the Member State proposed by the sponsor shall be the coordinating 
Member  State.  If  another  Member  State  than  the  one  proposed  by  the  sponsor 
becomes  coordinating  Member  State,  the  deadline  referred  to  in  Article  51(2)  shall 
start on the day following the acceptance. 

Under the direction of the coordinating Member State referred to in paragraph 2, the 
Member  States  concerned  shall  coordinate  their  assessment  of  the  application,  in 
particular  of  the  documentation  submitted  in  accordance  with  Chapter  II  of  Annex 
XIV,  except  for  Sections  3.1.3,  4.2,  4.3  and  4.4  thereof  which  shall  be  assessed 
separately by each Member State concerned.  

The coordinating Member State shall:  

(a)  within 6 days of receipt of the single application notify the sponsor whether the 
clinical investigation falls within the scope of this Regulation and whether the 
application is complete, except for the documentation submitted in accordance 
with  Sections  3.1.3,  4.2,  4.3  and  4.4  of  Chapter  II  of  Annex  XIV  for  which 
each  Member  State  shall  verify  the  completeness.  Article  51(2)  to  (4)  shall 
apply to the coordinating Member State in relation to the verification that the 
clinical  investigation  falls  within  the  scope  of  this  Regulation  and  that  the 
application is complete, except for the documentation submitted in accordance 
with Sections 3.1.3, 4.2, 4.3 and 4.4 of Chapter II of Annex XIV. Article 51(2) 
to (4) shall apply to each Member State in relation to the verification that the 
documentation submitted in accordance with Sections 3.1.3, 4.2, 4.3 and 4.4 of 
Chapter II of Annex XIV is complete;  

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(b) 

establish the results of the coordinated assessment in a report to be taken into 
account by the other Member States concerned when deciding on the sponsor’s 
application in accordance with Article 51(5).  

The  substantial  modifications  referred  to  in  Article  55  shall  be  notified  to  the 
Member States concerned by means of the electronic system referred to in Article 53. 
Any assessment as to whether there are grounds for refusal as referred to in Article 
55 shall be carried out under the direction of the coordinating Member State. 

For the  purpose  of Article 57(3), the sponsor shall submit the clinical investigation 
report to the Member States concerned by means of the electronic system referred to 
in Article 53. 

The Commission shall provide secretarial support to the coordinating Member State 
in the accomplishment of its tasks provided for in this Chapter.  

4. 

5. 

6. 

Article 59 
Recording and reporting of events occurring during clinical investigations 

1. 

The sponsor shall fully record any of the following: 

(a) 

an  adverse  event  identified  in  the  clinical  investigation  plan  as  critical  to  the 
evaluation  of  the  results  of  the  clinical  investigation  in  view  of  the  purposes 
referred to in Article 50(1);  

(b) 

a serious adverse event;  

(c) 

a  device  deficiency  that  might  have  led  to  a  serious  adverse  event  if  suitable 
action had not been taken, intervention had not occurred, or circumstances had 
been less fortunate; 

(d)  new findings in relation to any event referred to in points (a) to (c). 

2. 

The  sponsor  shall  report  to  all  Member  States  where  a  clinical  investigation  is 
conducted without delay any of the following: 

(a) 

(b) 

a  serious  adverse  event  that  has  a  causal  relationship  with  the  investigational 
device,  the  comparator  or  the  investigation  procedure  or  where  such  causal 
relationship is reasonably possible; 

a  device  deficiency  that  might  have  led  to  a  serious  adverse  event  if  suitable 
action had not been taken, intervention had not occurred, or circumstances had 
been less fortunate; 

(c)  new findings in relation to any event referred to in points (a) to (b). 

The time period for reporting shall take account of the severity of the event. Where 
necessary  to  ensure  timely  reporting,  the  sponsor  may  submit  an  initial  incomplete 
report followed up by a complete report. 

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3. 

4. 

The sponsor shall also report to the Member States concerned any event referred to 
in  paragraph  2  occurring  in  third  countries  in  which  a  clinical  investigation  is 
performed under the same clinical investigation plan as the one applying to a clinical 
investigation covered by this Regulation.  

In  the  case  of  a  clinical  investigation  for  which  the  sponsor  has  used  the  single 
application referred to in Article 58, the sponsor shall report any event as referred to 
in  paragraph  2  by  means  of  the  electronic  system  referred  to  in  Article  53.  Upon 
receipt, this report shall be transmitted electronically to all Member States concerned.  

Under the direction of the coordinating Member State referred to in Article 58(2), the 
Member States shall coordinate their assessment of serious adverse events and device 
deficiencies  to  determine  whether  a  clinical  investigation  needs  to  be  terminated, 
suspended, temporarily halted or modified. 

This paragraph shall not affect the rights of the other Member States to perform their 
own evaluation and to adopt measures in accordance with this Regulation in order to 
ensure the protection of public health and patient safety. The coordinating Member 
State  and  the  Commission  shall  be  kept  informed  of  the  outcome  of  any  such 
evaluation and the adoption of any such measures. 

5. 

In  the  case  of  post-market  clinical  follow-up  investigations  referred  to  in  Article 
54(1), the provisions on vigilance contained in Articles 61 to 66 shall apply instead 
of this Article. 

Article 60 
Implementing acts 

The Commission may, by means of implementing acts, adopt the modalities and procedural 
aspects necessary for the implementation of this Chapter as regards the following: 

(a)  harmonised  forms  for  the  application  for  clinical  investigations  and  their 
assessment  as  referred  to  in  Articles  51  and  58,  taking  into  account  specific 
categories or groups of devices;  

(b) 

the functioning of the electronic system referred to in Article 53; 

(c)  harmonised  forms  for  the  notification  of  post-market  clinical  follow-up 
investigations  as  referred  to  in  Article  54(1),  and  of  substantial  modifications 
as referred to in Article 55; 

(d) 

the  exchange  of  information  between  Member  States  as  referred  to  in  Article 
56; 

(e)  harmonised  forms  for  the  reporting  of  serious  adverse  events  and  device 

deficiencies as referred to in Article 59;  

(f) 

the  timelines  for  the  reporting  of  serious  adverse  events  and  device 
deficiencies,  taking  into  account  the  severity  of  the  event  to  be  reported  as 
referred to in Article 59.  

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Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 88(3). 

Chapter VII 
Vigilance and market surveillance 

SECTION 1 – VIGILANCE 

Article 61 
Reporting of incidents and field safety corrective actions 

1. 

Manufacturers  of  devices  other  than  custom-made  or  investigational  devices,  shall 
report through the electronic system referred to in Article 62 the following: 

(a) 

any serious incident in respect of devices made available on the Union market;  

(b) 

any  field  safety  corrective  action  in  respect  of  devices  made  available  on  the 
Union market, including any field safety corrective action undertaken in a third 
country  in  relation  to  a  device  which  is  also  legally  made  available  on  the 
Union market if the reason for the field safety corrective action is not limited to 
the device made available in the third country. 

Manufacturers  shall  make  the  report  referred  to  in  the  first  subparagraph  without 
delay, and no later than 15 days after they have become aware of the event and the 
causal  relationship  with  their  device  or  that  such  causal  relationship  is  reasonably 
possible.  The  time  period  for  reporting  shall  take  account  of  the  severity  of  the 
incident. Where necessary to ensure timely reporting, the manufacturer may submit 
an initial incomplete report followed up by a complete report. 

For similar serious incidents occurring with the same device or device type and for 
which  the  root  cause  has  been  identified  or  the  field  safety  corrective  action 
implemented,  manufacturers  may  provide  periodic  summary  reports  instead  of 
individual incident reports, on condition that the competent authorities referred to in 
points  (a),  (b)  and  (c)  of  Article  62(5)  have  agreed  with  the  manufacturer  on  the 
format, content and frequency of the periodic summary reporting. 

The  Member  States  shall  take  all  appropriate  measures  to  encourage  healthcare 
professionals,  users  and  patients  to  report  to  their  competent  authorities  suspected 
serious  incidents  referred  to  in  point  (a)  of  paragraph  1.  They  shall  record  such 
reports  centrally  at  national  level.  Where  a  competent  authority  of  a  Member  State 
obtains such reports, it shall take the necessary steps to ensure that the manufacturer 
of  the  device  concerned  is  informed  of  the  incident.  The  manufacturer  shall  ensure 
the appropriate follow-up.  

The Member States shall coordinate between them the development of standard web-
based structured forms for reporting of serious incidents by healthcare professionals, 
users and patients. 

2. 

3. 

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4. 

Manufacturers  of  custom-made  devices  shall  report  any  serious  incidents  and  field 
safety corrective actions referred to in paragraph 1 to the competent authority of the 
Member State in which the device in question has been made available.  

Article 62 
Electronic system on vigilance  

1. 

The Commission shall, in collaboration with the Member States, set up and manage 
an electronic system to collate and process the following information:  

(a) 

the  reports  by  manufacturers  on  serious  incidents  and  field  safety  corrective 
actions referred to in Article 61(1);  

(b) 

the periodic summary reports by manufacturers referred to in Article 61(2); 

(c) 

the  reports  by  competent  authorities  on  serious  incidents  referred  to  in  the 
second subparagraph of Article 63(1); 

(d) 

the reports by manufacturers on trends referred to in Article 64; 

(e) 

the field safety notices by manufacturers referred to in Article 63(5); 

(f) 

the  information  to  be  exchanged  between  the  competent  authorities  of  the 
Member  States  and  between  them  and  the  Commission  in  accordance  with 
Article 63(4) and (7).  

The information collated and processed by the electronic system shall be accessible 
to  the  competent  authorities  of  the  Member  States,  to  the  Commission  and  to  the 
notified bodies. 

The  Commission  shall  ensure  that  healthcare  professionals  and  the  public  have 
appropriate levels of access to the electronic system. 

On the basis of arrangements between the Commission and competent authorities of 
third  countries  or  international  organisations,  the  Commission  may  grant  those 
competent  authorities  or  international  organisations  access  to  the  database  at  the 
appropriate  level.  Those  arrangements  shall  be  based  on  reciprocity  and  make 
provision for confidentiality and data protection equivalent to those applicable in the 
Union.  

The  reports  on  serious  incidents  and  field  safety  corrective  actions  referred  to  in 
points (a) and (b) of Article 61(1), the periodic summary reports referred to in Article 
61(2),  the  reports  on  serious  incidents  referred  to  in  the  second  subparagraph  of 
Article  63(1)  and  the  trend  reports  referred  to  in  Article  64  shall  be  automatically 
transmitted upon receipt via the electronic system to the competent authorities of the 
following Member States:  

(a) 

the Member State where the incident occurred;  

(b) 

the Member State where the field safety corrective action is being or is to be 
undertaken;  

2. 

3. 

4. 

5. 

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1. 

2. 

3. 

(c) 

the Member State where the manufacturer has his registered place of business;  

(d)  where  applicable,  the  Member  State  where  the  notified  body,  that  issued  a 
certificate  in  accordance  with  Article  45  for  the  device  in  question,  is 
established. 

Article 63 
Analysis of serious incidents and field safety corrective actions 

Member  States  shall  take  the  necessary  steps  to  ensure  that  any  information 
regarding a serious incident that has occurred within their territory or a field safety 
corrective action that has been or is to be undertaken within their territory, and that is 
brought  to  their  knowledge  in  accordance  with  Article  61  is,  at  national  level, 
evaluated  centrally  by  their  competent  authority,  if  possible  together  with  the 
manufacturer.  

If  in  the  case  of  reports  received  in  accordance  with  Article  61(3)  the  competent 
authority ascertains that the reports relate to a serious incident it shall notify without 
delay those reports to the electronic system referred to in Article 62, unless the same 
incident has already been reported by the manufacturer. 

The  national  competent  authorities  shall  carry  out  a  risk  assessment  with  regard  to 
reported  serious  incidents  or  field  safety  corrective  actions,  taking  into  account 
criteria such as causality, detectability and probability of recurrence of the problem, 
frequency  of  use  of  the  device,  probability  of  occurrence  of  harm  and  severity  of 
harm,  clinical  benefit  of  the  device,  intended  and  potential  users,  and  population 
affected. They shall also evaluate  the adequacy  of the  field  safety corrective action 
envisaged or undertaken by the manufacturer and the need for and kind of any other 
corrective  action.  They  shall  monitor  the  manufacturer’s  investigation  of  the 
incident.  

In the case of devices referred to in the first subparagraph of Article 1(4) and where 
the  serious  incident  or  field  safety  corrective  action  may  be  related  to  a  substance 
which,  if  used  separately,  would  be  considered  to  be  a  medicinal  product,  the 
evaluating competent authority or the coordinating competent authority referred to in 
paragraph 6 shall inform the relevant competent authority for medicinal products, or 
the European Medicines Agency (EMA), that was consulted by the notified body in 
accordance with the second subparagraph of Article 42(2). 

In  the  case  of  devices  covered  by  this  Regulation  in  accordance  with  point  (e)  of 
Article 1(2) and where the serious incident or field safety corrective action may be 
related  to  the  tissues  or  cells  of  human  origin  utilised  for  the  manufacture  of  the 
device, the competent authority or the coordinating competent authority referred to in 
paragraph 6 shall inform the relevant competent authority for human tissues and cells 
that was consulted by the notified body in accordance with the third subparagraph of 
Article 42(2). 

4. 

After carrying out the assessment, the evaluating competent authority shall, through 
the  electronic  system  referred  to  in  Article  62,  inform  without  delay  the  other 
competent authorities of the corrective action taken or envisaged by the manufacturer 

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or imposed on him to minimise the risk of recurrence of a serious incident, including 
information on the underlying events and the outcome of its assessment. 

5. 

The manufacturer shall ensure that the users of the device in question are informed 
without delay of the corrective action taken by means of a field safety notice. Except 
in case of urgency, the content of the draft field safety notice shall be submitted to 
the  evaluating  competent  authority  or,  in  cases  referred  to  in  paragraph  6  of  this 
Article,  the  coordinating  competent  authority  to  allow  them  to  make  comments. 
Unless duly justified by the situation of the individual Member State, the content of 
the field safety notice shall be consistent in all Member States. 

The manufacturer shall enter the field safety notice in the electronic system referred 
to in Article 62 through which that notice shall be accessible to the public.  

6. 

The  competent  authorities  shall  designate  a  coordinating  competent  authority  to 
coordinate their assessments referred to in paragraph 2 in the following cases: 

(a)  where similar serious incidents related to the same device or type of device of 

the same manufacturer occur in more than one Member State; 

(b)  where the field safety corrective action is being or is to be undertaken in more 

than one Member State. 

Unless  otherwise  agreed  between  the  competent  authorities,  the  coordinating 
competent  authority  shall  be  the  one  of  the  Member  State  where  the  manufacturer 
has his registered place of business.  

The  coordinating  competent  authority  shall  inform  the  manufacturer,  the  other 
competent  authorities  and  the  Commission  that  it  has  assumed  the  role  of 
coordinating authority. 

7. 

The coordinating competent authority shall carry out the following tasks:  

(a) 

(b) 

(c) 

(d) 

(e) 

to monitor the investigation of the serious incident by the manufacturer and the 
corrective action to be taken;  

to  consult  with  the  notified  body  that  issued  a  certificate  in  accordance  with 
Article  45  for  the  device  in  question  regarding  the  impact  of  the  serious 
incident on the certificate; 

to agree with the manufacturer and the other competent authorities referred to 
in  points  (a)  to  (c)  of  Article  62(5)  on  the  format,  content  and  frequency  of 
periodic summary reports in accordance with Article 61(2); 

to  agree  with  the  manufacturer  and  other  competent  authorities  concerned  on 
the implementation of the appropriate field safety corrective action; 

to  inform  the  other  competent  authorities  and  the  Commission,  through  the 
electronic system referred to in Article 62, of the progress in and the outcome 
of its assessment. 

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The designation of  a  coordinating competent authority  shall  not affect the  rights of 
the  other  competent  authorities  to  perform  their  own  assessment  and  to  adopt 
measures  in  accordance  with  this  Regulation  in  order  to  ensure  the  protection  of 
public  health  and  patient  safety.  The  coordinating  competent  authority  and  the 
Commission shall be kept informed of the outcome of any such assessment and the 
adoption of any such measures.  

8. 

The  Commission  shall  provide  secretarial  support  to  the  coordinating  competent 
authority in the accomplishment of its tasks under this Chapter. 

Article 64 
Trend reporting 

Manufacturers  of  devices  classified  in  class  IIb  and  III  shall  report  to  the  electronic  system 
referred  to  in  Article  62  any  statistically  significant  increase  in  the  frequency  or  severity  of 
incidents  that  are  not  serious  incidents  or  of  expected  undesirable  side-effects  that  have  a 
significant impact on the risk-benefit analysis referred to in Sections 1 and 5 of Annex I and 
which have led or may lead to unacceptable risks to the health or safety of patients, users or 
other persons when weighted against the intended benefits. The significant increase shall be 
established  in  comparison  to  the  foreseeable  frequency  or  severity  of  such  incidents  or 
expected undesirable side-effects in respect of the device, or category or group of devices, in 
question  during  a  specific  time  period  as  established  in  the  manufacturer’s  conformity 
assessment. Article 63 shall apply. 

Article 65 
Documentation of vigilance data 

Manufacturers  shall  update  their  technical  documentation  with  information  on  incidents 
received  from  healthcare  professionals,  patients  and  users,  serious  incidents,  field  safety 
corrective actions, periodic summary reports referred to in Article 61, trend reports referred to 
in  Article  64  and  field  safety  notices  referred  to  in  Article  63(5).  They  shall  make  this 
documentation  available  to  their  notified  bodies,  which  shall  assess  the  impact  of  the 
vigilance data on the conformity assessment and the certificate issued. 

Article 66 
Implementing acts 

The Commission may, by means of implementing acts, adopt the modalities and procedural 
aspects necessary for the implementation of Articles 61 to 65 as regards the following:  

(a) 

typology  of  serious  incidents  and  field  safety  corrective  actions  in  relation  to 
specific devices, or categories or groups of devices; 

(b)  harmonised  forms  for  the  reporting  of  serious  incidents  and  field  safety 
reports  by 

reports  and 

corrective  actions,  periodic  summary 
manufacturers as referred to in Articles 61 and 64;  

trend 

(c) 

timelines  for  the  reporting  of  serious  incidents  and  field  safety  corrective 
actions,  periodic  summary  reports  and  trend  reports  by  manufacturers,  taking 

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into account the severity of the event to be reported as referred to in Articles 61 
and 64; 

(d)  harmonised  forms  for  the  exchange  of  information  between  competent 

authorities as referred to in Article 63. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 88(3). 

SECTION 2 – MARKET SURVEILLANCE 

Article 67 
Market surveillance activities 

1. 

2. 

3. 

4. 

5. 

The competent authorities shall perform appropriate checks on the characteristics and 
performance of  devices  including, where appropriate, review of documentation  and 
physical  or  laboratory  checks  on  the  basis  of  adequate  samples.  They  shall  take 
account  of  established  principles  regarding  risk  assessment  and  risk  management, 
vigilance  data  and  complaints.  The  competent  authorities  may  require  economic 
operators  to  make  available  the  documentation  and  information  necessary  for  the 
purpose of carrying out their activities and, where necessary and justified, enter the 
premises  of  economic  operators  and  take  the  necessary  samples  of  devices.  They 
may destroy or otherwise render inoperable devices presenting a serious risk where 
they deem it necessary. 

The  Member  States  shall  periodically  review  and  assess  the  functioning  of  their 
surveillance  activities.  Such  reviews  and  assessments  shall  be  carried  out  at  least 
every four years and the results thereof shall be communicated to the other Member 
States and the Commission. The Member State concerned shall make a summary of 
the results accessible to the public. 

The  competent  authorities  of  the  Member  States  shall  coordinate  their  market 
surveillance activities, cooperate with each other and share with each other and with 
the Commission the results thereof. Where appropriate, the competent authorities of 
the Member States shall agree on work-sharing and specialisation. 

Where  more  than  one  authority  in  a  Member  State  is  responsible  for  market 
surveillance and external border controls, those authorities shall cooperate with each 
other, by sharing information relevant to their role and functions.  

The competent authorities of the Member States shall cooperate with the competent 
authorities  of  third  countries  with  a  view  to  exchanging  information  and  technical 
support and promoting activities relating to market surveillance. 

Article 68 
Electronic system on market surveillance 

1. 

The Commission, in collaboration with the Member States, shall set up and manage 
an electronic system to collate and process the following information: 

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(a) 

(b) 

(c) 

(d) 

information in relation to non-compliant devices presenting a risk to health and 
safety referred to in Article 70(2), (4) and (6); 

information  in  relation  to  compliant  devices  presenting  a  risk  to  health  and 
safety referred to in Article 72(2); 

information  in  relation  to  formal  non-compliance  of  products  referred  to  in 
Article 73(2); 

information in relation to preventive health protection measures referred to in 
Article 74(2). 

2. 

The information mentioned in paragraph 1 shall be immediately transmitted through 
the electronic system to all competent authorities concerned and be accessible to the 
Member States and to the Commission. 

Article 69 
Evaluation regarding devices presenting a risk to health and safety at national level 

Where  the  competent  authorities  of  a  Member  State,  based  on  vigilance  data  or  other 
information,  have  sufficient  reason  to  believe  that  a  device  presents  a  risk  to  the  health  or 
safety of patients, users or other persons, they shall carry out an evaluation in relation to the 
device concerned covering all the requirements laid down in this Regulation that are relevant 
to  the  risk  presented  by  the  device.  The  relevant  economic  operators  shall  cooperate  as 
necessary with the competent authorities. 

Article 70 
Procedure for dealing with non-compliant devices presenting a risk to health and safety 

1. 

2. 

3. 

Where,  having  performed  an  evaluation  pursuant  to  Article  69,  the  competent 
authorities  find  that  the  device,  which  presents  a  risk  to  the  health  or  safety  of 
patients, users or other persons, does not comply with the requirements laid down in 
this  Regulation,  they  shall  without  delay  require  the  relevant  economic  operator  to 
take  all  appropriate  and  duly  justified  corrective  action  to  bring  the  device  into 
compliance  with  those  requirements,  to  prohibit  or  restrict  the  making  available  of 
the  device  on  the  market,  to  subject  the  making  available  of  the  device  to  specific 
requirements,  to  withdraw  the  device  from  the  market,  or  to  recall  it  within  a 
reasonable period, proportionate to the nature of the risk.  

Where  the  competent  authorities  consider  that  non-compliance  is  not  restricted  to 
their  national  territory,  they  shall  inform  the  Commission  and  the  other  Member 
States of the results of the evaluation and of the actions which they have required the 
economic operators to take, by means of the electronic system referred to in Article 
68. 

The economic operators shall ensure that all appropriate corrective action is taken in 
respect  of  all  the  devices  concerned  that  they  have  made  available  on  the  market 
throughout the Union.  

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4. 

5. 

6. 

7. 

8. 

1. 

2. 

Where  the  relevant  economic  operator  does  not  take  adequate  corrective  action 
within the period referred to in paragraph 1, the competent authorities shall take all 
appropriate  provisional  measures  to  prohibit  or  restrict  the  device’s  being  made 
available  on  their  national  market,  to  withdraw  the  device  from  that  market  or  to 
recall it. 

They  shall  notify  the  Commission  and  the  other  Member  States,  without  delay,  of 
those measures, by means of the electronic system referred to in Article 68.  

The  notification  referred  to  in  paragraph  4  shall  include  all  available  details,  in 
particular  the  data  necessary  for  the  identification  of  the  non-compliant  device,  the 
origin of the device, the nature of and the reasons for the non-compliance alleged and 
the  risk  involved,  the  nature  and  duration  of  the  national  measures  taken  and  the 
arguments put forward by the relevant economic operator.  

Member  States  other  than  the  Member  State  initiating  the  procedure  shall  without 
delay  inform  the  Commission  and  the  other  Member  States  of  any  additional 
information at their disposal relating to the non-compliance of the device concerned 
and  of  any  measures  adopted  by  them  in  relation  to  the  device  concerned.  In  the 
event  of  disagreement  with  the  notified  national  measure,  they  shall  without  delay 
inform the Commission and the other Member States of their objections, by means of 
the electronic system referred to in Article 68. 

Where, within two months of receipt of the notification referred to in paragraph 4, no 
objection has been raised by either a Member State or the Commission in respect of a 
provisional  measure  taken  by  a  Member  State,  that  measure  shall  be  deemed 
justified.  

All  Member  States  shall  ensure  that  appropriate  restrictive  measures  are  taken 
without delay in respect of the device concerned. 

Article 71 
Procedure at Union level 

Where, within two months of receipt of the notification referred to in Article 70(4), 
objections  are  raised  by  a  Member  State  against  a  provisional  measure  taken  by 
another  Member  State,  or  where  the  Commission  considers  the  measure  to  be 
contrary  to  Union  legislation,  the  Commission  shall  evaluate  the  national  measure. 
On the basis of the results of that evaluation, the Commission shall decide, by means 
of  implementing  acts,  whether  or  not  the  national  measure  is  justified.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 88(3). 

If  the  national  measure  is  considered  justified,  Article  70(8)  shall  apply.  If  the 
national  measure  is  considered  unjustified,  the  Member  State  concerned  shall 
withdraw the  measure. Where, in  the  situations referred to in Articles 70  and 72, a 
Member  State  or  the  Commission  consider  that  the  risk  to  health  and  safety 
emanating  from  a  device  cannot  be  contained  satisfactorily  by  means  of  measures 
taken  by  the  Member  State(s)  concerned,  the  Commission,  at  the  request  of  a 
Member State or on its own initiative, may take, by means of implementing acts, the 

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necessary and duly justified measures to ensure the protection of health and safety, 
including  measures  restricting  or  prohibiting  the  placing  on  the  market  and  putting 
into  service  of  the  device  concerned.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 88(3). 

On duly justified imperative grounds of urgency relating to the health and safety of 
humans,  the  Commission  shall  adopt  immediately  applicable  implementing  acts 
referred  to  in  paragraphs  1  and  2  in  accordance  with  the  procedure  referred  to  in 
Article 88(4). 

Article 72 
Procedure for dealing with compliant devices presenting a risk to health and safety 

Where, having performed an evaluation pursuant to Article 69, a Member State finds 
that  although  a  device  has  been  legally  placed  on  the  market  or  put  into  service,  it 
presents a risk to the health or safety of patients, users or other persons or to other 
aspects  of  the  protection  of  public  health,  it  shall  require  the  relevant  economic 
operator or operators to take all appropriate provisional measures to ensure that the 
device concerned, when placed on the market or put into service, no longer presents 
that risk, to withdraw the device from the market or to recall it within a reasonable 
period, proportionate to the nature of the risk. 

The Member State shall immediately notify the Commission and the other Member 
States of the measures taken, by means of the electronic system referred to in Article 
68.  That  information  shall  include  the  data  necessary  for  the  identification  of  the 
device concerned, the origin and the supply chain of the device, the findings of the 
Member State's evaluation specifying the nature of the risk involved and the nature 
and duration of the national measures taken.  

The Commission shall evaluate the provisional national measures taken. On the basis 
of  the  results  of  that  evaluation,  the  Commission  shall  decide,  by  means  of 
implementing acts, whether or not the measure is justified. Those implementing acts 
shall be adopted in accordance with the examination procedure referred to in Article 
88(3).  On  duly  justified  imperative  grounds  of  urgency  relating  to  the  health  and 
safety of humans, the Commission shall adopt immediately applicable implementing 
acts in accordance with the procedure referred to in Article 88(4). 

Where the national measure is considered justified, Article 70(8) shall apply. If the 
national  measure  is  considered  unjustified,  the  Member  State  concerned  shall 
withdraw the measure.  

Article 73 
Formal non-compliance 

Without prejudice to Article 70, a Member State shall require the relevant economic 
operator to put an end to the non-compliance concerned within a reasonable period 
that  is  proportionate  to  the  non-compliance  where  it  makes  one  of  the  following 
findings: 

3. 

1. 

2. 

3. 

4. 

1. 

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(a) 

that  the  CE  marking  has  been  affixed  in  violation  of  the  formal  requirements 
laid down in Article 18; 

(b) 

that the CE marking has not been affixed to a device contrary to Article 18; 

(c) 

(d) 

(e) 

that  the  CE  marking  has  been  inappropriately  affixed  in  accordance  with 
procedures  in  this  Regulation  on  a  product  that  is  not  covered  by  this 
Regulation;  

that  the  EU  declaration  of  conformity  has  not  been  drawn  up  or  is  not 
complete; 

that the information to be supplied by the manufacturer on the label or in the 
instructions  for  use  is  not  available,  not  complete  or  not  provided  in  the 
language(s) required;  

(f) 

that  the  technical  documentation,  including  the  clinical  evaluation,  is  not 
available or not complete. 

Where the economic operator does not put an end to the non-compliance within the 
period  referred  to  in  paragraph  1,  the  Member  State  concerned  shall  take  all 
appropriate measures to restrict or prohibit the product being made available on the 
market or to ensure that it is recalled or withdrawn from the market. That Member 
State  shall  inform  the  Commission  and  the  other  Member  States  without  delay  of 
those measures, by means of the electronic system referred to in Article 68. 

Article 74 
Preventive health protection measures 

Where  a  Member  State,  after  having  performed  an  evaluation  which  indicates  a 
potential risk related to a device or a specific category or group of devices considers 
that  the  making  available  on  the  market  or  putting  into  service  of  such  device  or 
specific category or group of devices should be prohibited, restricted or made subject 
to particular requirements or that such device or category or group of devices should 
be withdrawn from the market or recalled in order to protect the health and safety of 
patients,  users  or  other  persons  or  other  aspects  of  public  health,  it  may  take  any 
necessary and justified provisional measures. 

The  Member  State  shall  immediately  notify  the  Commission  and  all  other  Member 
States, giving the reasons for its decision, by means of the electronic system referred 
to in Article 68.  

The  Commission  shall  assess  the  provisional  national  measures  taken.  The 
Commission  shall  decide,  by  means  of  implementing  acts,  whether  the  national 
measures  are  justified  or  not.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 88(3).  

On duly justified imperative grounds of urgency relating to the health and safety of 
humans,  the  Commission  may  adopt  immediately  applicable  implementing  acts  in 
accordance with the procedure referred to in Article 88(4). 

2. 

1. 

2. 

3. 

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4. 

1. 

2. 

3. 

4. 

Where  the  assessment  referred  to  in  paragraph  3  demonstrates  that  the  making 
available on the market or putting into service of a device, specific category or group 
of devices should be prohibited, restricted or made subject to particular requirements 
or  that  such  device  or  category  or  group  of  devices  should  be  withdrawn  from  the 
market or recalled in all Member States in order to protect the health and safety of 
patients,  users  or  other  persons  or  other  aspects  of  public  health,  the  Commission 
shall be empowered to adopt delegated acts in accordance with Article 89 to take the 
necessary and duly justified measures. 

Where in this case imperative grounds of urgency so require, the procedure provided 
for in Article 90 shall apply to delegated acts adopted pursuant to this paragraph. 

Article 75 
Good administrative practice 

Any measure adopted by the competent authorities of the Member States pursuant to 
Articles  70  to  74  shall  state  the  exact  grounds  on  which  it  is  based.  Where  it  is 
addressed  to  a  specific  economic  operator,  it  shall  be  notified  without  delay  to  the 
economic  operator  concerned,  who  shall  at  the  same  time  be  informed  of  the 
remedies available to him under the law of the Member State concerned and of the 
time  limits  to  which  such  remedies  are  subject.  Where  the  measure  is  of  general 
scope, it shall be appropriately published.  

Except  in  cases  where  immediate  action  is  necessary  for  reasons  of  serious  risk  to 
human  health  or  safety,  the  economic  operator  concerned  shall  be  given  the 
opportunity  to  make  submissions  to  the  competent  authority  within  an  appropriate 
period  of  time  before  any  measure  is  adopted. If action has been taken without the 
economic  operator’s  being  heard,  he  shall  be  given  the  opportunity  to  make 
submissions  as  soon  as  possible  and  the  action  taken  shall  be  reviewed  promptly 
thereafter. 

Any  measure  adopted  shall  be  immediately  withdrawn  or  amended  upon  the 
economic operator’s demonstrating that he has taken effective corrective action. 

Where a measure adopted pursuant to Articles 70 to 74 concerns a product for which 
a  notified  body  has  been  involved  in  the  conformity  assessment,  the  competent 
authorities shall inform the relevant notified body of the measure taken.  

Chapter VIII 
Cooperation between Member States, Medical Device 
Coordination Group, EU reference laboratories, device registers 

Article 76 
Competent authorities  

1. 

The Member States shall designate the competent authority or authorities responsible 
for  the  implementation  of  this  Regulation.  They  shall  entrust  their  authorities  with 
the  powers,  resources,  equipment  and  knowledge  necessary  for  the  proper 

EN 

89 

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2. 

1. 

2. 

1. 

2. 

3. 

4. 

performance  of  their  tasks  pursuant  to  this  Regulation.  The  Member  States  shall 
communicate the competent authorities to the Commission which shall publish a list 
of competent authorities.  

For  the  implementation  of  Articles  50  to  60,  the  Member  States  may  designate  a 
national  contact  point  other  than  a  national  authority.  In  this  case,  references  to  a 
competent authority in this Regulation shall be understood as including the national 
contact point. 

Article 77 
Cooperation  

The competent authorities of the Member States shall cooperate with each other and 
with  the  Commission  and  exchange  with  each  other  the  information  necessary  to 
enable this Regulation to be applied uniformly. 

Member  States  and  the  Commission  shall  participate  in  initiatives  developed  at 
international  level  with  the  aim  of  ensuring  cooperation  between  regulatory 
authorities in the field of medical devices. 

Article 78 
Medical Device Coordination Group 

A Medical Device Coordination Group (MDCG) is hereby established.  

Each Member State shall appoint, for a three-year term which may be renewed, one 
member and one alternate providing expertise in the field of this Regulation, and one 
member  and  one  alternate  providing  expertise  in  the  field  of  Regulation  (EU)  No 
[…/…]  [on  in  vitro  diagnostic  medical  devices].  A  Member  State  may  choose  to 
appoint only one member and one alternate providing expertise in both fields.  

The members of the MDCG shall be chosen for their competence and experience in 
the  field  of  medical  devices  and  in  vitro  diagnostic  medical  devices.  They  shall 
represent the competent authorities of the Member States. The names and affiliation 
of members shall be made public by the Commission. 

The alternates shall represent and vote for the members in their absence.  

The  MDCG  shall  meet  at  regular  intervals  and,  where  the  situation  requires,  on  a 
request  from  the  Commission  or  a  Member  State.  The  meetings  shall  be  attended 
either  by  the  members  appointed  for  their  role  and  expertise  in  the  field  of  this 
Regulation, or by the members appointed for their expertise in the field of Regulation 
(EU)  No  […/…]  [on  in  vitro  diagnostic  medical  devices],  or  by  the  members 
appointed for both Regulations, as appropriate.  

The  MDCG  shall  use  its  best  endeavours  to  reach  consensus.  If  such  consensus 
cannot be reached, the MDCG shall decide by the majority of its members. Members 
with diverging positions may request that their positions and the grounds on which 
they are based are recorded in the MDCG's position. 

EN 

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5. 

6. 

7. 

8. 

The MDCG shall be chaired by a representative of the Commission. The chair shall 
not take part in votes of the MDCG.  

The  MDCG  may  invite,  on  a  case-by-case  basis,  experts  and  other  third  parties  to 
attend meetings or provide written contributions. 

The  MDCG  may  establish  standing  or  temporary  sub-groups.  Where  appropriate, 
organisations  representing  the  interests  of  the  medical  device  industry,  healthcare 
professionals, laboratories, patients and consumers at Union level shall be invited in 
such sub-groups in the capacity of observers.  

The MDCG shall establish its rules of procedure which shall, in particular, lay down 
procedures for the following: 

– 

– 

– 

the adoption of opinions or recommendations or other positions by the MDCG, 
including in cases of urgency;  

the delegation of tasks to reporting and co-reporting members; 

the functioning of sub-groups.  

The  rules  of  procedure  shall  enter  into  force  after  receiving  a  favourable  opinion 
from the Commission. 

Article 79 
Support by the Commission 

The Commission shall support the functioning of the cooperation between national competent 
authorities  and  provide  technical,  scientific  and  logistic  support  to  the  MDCG  and  its  sub-
groups. It shall organise the  meetings of the MDCG and its sub-groups, participate  in  those 
meetings and ensure the appropriate follow-up. 

Article 80 
Tasks of the MDCG 

The MDCG shall have the following tasks: 

(a) 

(b) 

(c) 

to contribute to the assessment of applicant conformity assessment bodies and 
notified bodies pursuant to the provisions set out in Chapter IV; 

to  contribute  to  the  scrutiny  of  certain  conformity  assessments  pursuant  to 
Article 44; 

to  contribute  to  the  development  of  guidance  aimed  at  ensuring  effective  and 
harmonised  implementation  of  this  Regulation,  in  particular  regarding  the 
designation and monitoring of notified bodies, application of the general safety 
and  performance  requirements  and  conduct  of  the  clinical  evaluation  by 
manufacturers and the assessment by notified bodies; 

EN 

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(d) 

(e) 

(f) 

to  assist the  competent  authorities of the Member States in their coordination 
activities  in  the  fields  of  clinical  investigations,  vigilance  and  market 
surveillance; 

to provide advice and assist the Commission, at its request, in its assessment of 
any issue related to the implementation of this Regulation; 

to  contribute  to  harmonised  administrative  practice  with  regard  to  medical 
devices in the Member States. 

Article 81 
European Union reference laboratories 

1. 

For specific devices, or a category or group of devices, or for specific hazards related 
to  a  category  or  group  of  devices,  the  Commission  may  designate,  by  means  of 
implementing  acts,  one  or  more  European  Union  reference  laboratories,  hereinafter 
referred to as 'EU reference laboratories', that satisfy the criteria set out in paragraph 
3.  The  Commission  shall  only  designate  laboratories  for  which  a  Member  State  or 
the  Commission's  Joint  Research  Centre  have  submitted  an  application  for 
designation. 

2. 

Within  the  scope  of  their  designation,  the  EU  reference  laboratories  shall,  where 
appropriate, have the following tasks: 

(a) 

(b) 

(c) 

(d) 

(e) 

to provide scientific and technical assistance to the Commission, the Member 
States and notified bodies in relation to the implementation of this Regulation; 

to provide scientific advice regarding the state of the art in relation to specific 
devices, or a category or group of devices; 

to set up and manage a network of national reference laboratories and publish a 
list  of  the  participating  national  reference  laboratories  and  their  respective 
tasks; 

to contribute to the development of appropriate testing and analysis methods to 
be applied for conformity assessment procedures and market surveillance; 

to collaborate with notified bodies in the development of best practices for the 
performance of conformity assessment procedures; 

(f) 

to contribute to the development of standards at international level; 

(g) 

to provide scientific opinions in response to consultations by notified bodies in 
accordance with this Regulation. 

3. 

EU reference laboratories shall satisfy the following criteria: 

(a) 

to have appropriately qualified staff with adequate knowledge and experience 
in the field of the medical devices for which they are designated; 

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(b) 

to possess the necessary equipment and reference material to carry out the tasks 
assigned to them; 

(c) 

to have the necessary knowledge of international standards and best practices; 

(d) 

to have an appropriate administrative organisation and structure; 

(e) 

to ensure that their staff observe the confidentiality of the information and data 
obtained in carrying out their tasks. 

4. 

EU reference laboratories may be granted a Union financial contribution. 

The Commission may adopt, by means of implementing acts, the modalities and the 
amount  of  the  grant  of a Union financial contribution to  EU reference laboratories, 
taking  into  account  the  objectives  of  protection  of  health  and  safety,  support  of 
innovation  and  cost-effectiveness.  Those  implementing  acts  shall  be  adopted  in 
accordance with the examination procedure referred to in Article 88(3). 

Where notified bodies or Member States request scientific or technical assistance or 
a  scientific  opinion  from  an  EU  reference  laboratory,  they  may  be  required  to  pay 
fees to wholly or partially cover the costs incurred by that laboratory in carrying out 
the  requested  task  according  to  a  set  of  predetermined  and  transparent  terms  and 
conditions.  

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 89 for the following purposes: 

(a) 

(b) 

amending or supplementing the tasks of EU reference laboratories referred to 
in  paragraph  2  and  the  criteria  to  be  satisfied  by  EU  reference  laboratories 
referred to in paragraph 3.  

setting  out  the  structure  and  the  level  of  the  fees  referred  to  in  paragraph  5 
which  may  be  levied  by  an  EU  Reference Laboratory for providing scientific 
opinions in response to consultations by notified bodies in accordance with this 
Regulation,  taking  into  account  the  objectives  of  protection  of  human  health 
and safety, support of innovation and cost-effectiveness.  

EU  reference  laboratories  shall  be  subject  to  controls,  including  on-site  visits  and 
audits,  by  the  Commission  to  verify  compliance  with  the  requirements  of  this 
Regulation.  If  these  controls  find  that  a  laboratory  is  not  complying  with  those 
requirements  for  which  they  have  been  designated,  the  Commission,  by  means  of 
implementing acts, shall take appropriate measures, including the withdrawal of the 
designation. 

Article 82 
Conflict of interests 

Members  of  the  MDCG  and  staff  of  the  EU  reference  laboratories  shall  not  have 
financial  or  other  interests  in  the  medical  device  industry  which  could  affect  their 
impartiality. They shall undertake to act in the public interest and in an independent 
manner.  They  shall  declare  any  direct  and  indirect  interests  they  may  have  in  the 

5. 

6. 

7. 

1. 

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medical  device  industry  and  update  this  declaration  whenever  a  relevant  change 
occurs.  Upon  request,  the  declaration  of  interests  shall  be  accessible  to  the  public. 
This  Article  shall  not  apply  to  the  representatives  of  stakeholder  organisations 
participating in the sub-groups of the MDCG. 

2. 

Experts and other third parties invited by the MDCG on a case-by-case basis shall be 
requested to declare their interests in the issue in question. 

Article 83 
Device registers 

The Commission and the Member States shall take all appropriate measures to encourage the 
establishment  of  registers  for  specific  types  of  devices  to  gather  post-market  experience 
related  to  the  use  of  such  devices.  Such  registers  shall  contribute  to  the  independent 
evaluation of the long-term safety and performance of devices. 

Chapter IX 
Confidentiality, data protection, funding, penalties  

Article 84 
Confidentiality 

1. 

2. 

3. 

Unless  otherwise  provided  in  this  Regulation  and  without  prejudice  to  existing 
national provisions and practices in the Member States on medical confidentiality, all 
parties involved in the application of this Regulation shall respect the confidentiality 
of  information  and  data  obtained  in  carrying  out  their  tasks  in  order  to  protect  the 
following:  

(a)  personal data in compliance with Directive 95/46/EC and Regulation (EC) No 

45/2001;  

(b) 

(c) 

commercial  interests  of  a  natural  or  legal  person,  including  intellectual 
property rights;  

the effective implementation of this Regulation, in particular for the purpose of 
inspections, investigations or audits.  

Without  prejudice  to  paragraph  1,  information  exchanged  between  competent 
authorities  and  between  competent  authorities  and  the  Commission  on  condition  of 
confidentiality  shall  remain  confidential  unless  the  originating  authority  has  agreed 
to its disclosure.  

Paragraphs  1  and  2  shall  not  affect  the  rights  and  obligations  of  the  Commission, 
Member States and  notified bodies with regard to exchange of information and the 
dissemination  of  warnings,  nor  the  obligations  of  the  persons  concerned  to  provide 
information under criminal law.  

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4. 

1. 

2. 

The  Commission  and  Member  States  may  exchange  confidential  information  with 
regulatory authorities of third countries with which they have concluded bilateral or 
multilateral confidentiality arrangements. 

Article 85 
Data protection 

Member  States  shall  apply  Directive  95/46/EC  to  the  processing  of  personal  data 
carried out in the Member States pursuant to this Regulation. 

Regulation  (EC)  No  45/2001  shall  apply  to  the  processing  of  personal  data  carried 
out by the Commission pursuant to this Regulation. 

Article 86 
Levy of fees 

This Regulation shall be without prejudice to the possibility for Member States to levy fees 
for  the  activities  set  out  in  this  Regulation,  provided  that  the  level  of  the  fees  is  set  in  a 
transparent  manner  and  on  the  basis  of  cost  recovery  principles.  They  shall  inform  the 
Commission and the other Member States at least three months before the structure and level 
of fees is to be adopted. 

Article 87 
Penalties 

The Member States shall lay down the provisions on penalties applicable for infringement of 
the provisions of this Regulation and shall take all measures necessary to ensure that they are 
implemented. The penalties provided for must be effective, proportionate, and dissuasive. The 
Member States shall notify those provisions to the Commission by [3 months prior to the date 
of  application  of  the  Regulation]  and  shall  notify  it  without  delay  of  any  subsequent 
amendment affecting them. 

Chapter X 
Final provisions 

Article 88 
Committee procedure 

1. 

2. 

3. 

The  Commission  shall  be  assisted  by  a  Committee  on  Medical  Devices.  That 
Committee  shall  be  a  committee  within  the  meaning  of  Regulation  (EU)  No 
182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  4  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

EN 

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4. 

1. 

2. 

3. 

4. 

5. 

1. 

2. 

Where  reference  is  made  to  this  paragraph,  Article  8  of  Regulation  (EU)  No 
182/2011, in conjunction with Article 4 or Article 5, as appropriate, shall apply. 

Article 89 
Exercise of the delegation 

The power to adopt the delegated acts referred to in Articles 2(2) and (3), 4(5), 8(2), 
17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) 
is conferred on the Commission subject to the conditions laid down in this Article.  

The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 
25(7),  29(2),  40(2),  41(4),  42(11),  45(5),  51(7),  53(3),  74(4)  and  81(6)  shall  be 
conferred  on  the  Commission  for  an  indeterminate  period  of  time  from  the  date  of 
entry into force of this Regulation. 

The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 
25(7),  29(2),  40(2),  41(4),  42(11),  45(5),  51(7),  53(3),  74(4)  and  81(6)  may  be 
revoked  at  any  time  by  the  European  Parliament  or  by  the  Council.  A  decision  of 
revocation shall put an end to the delegation of the power specified in that decision. 
It  shall  take  effect  the  day  following  its  publication  in  the  Official  Journal  of  the 
European Union or at a later date specified therein. It shall not affect the validity of 
any delegated acts already in force. 

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to 
the European Parliament and to the Council.  

A  delegated  act  adopted  pursuant  to  any  of  the  Articles  listed  in  paragraph  1  shall 
enter  into  force  only  if  no  objection  has  been  expressed  either  by  the  European 
Parliament or by the Council within a period of two months of notification of that act 
to the European Parliament and the Council or if, before the expiry of that period, the 
European Parliament and the Council have both informed the Commission that they 
will not object. That period may be extended by two months at the initiative of the 
European Parliament or the Council. 

Article 90 
Urgency procedure for delegated acts 

Delegated  acts  adopted  under  this  Article  shall  enter  into  force  without  delay  and 
shall apply as long as no objection is expressed in accordance with paragraph 2. The 
notification  of  a  delegated  act  to  the  European  Parliament  and  to  the  Council  shall 
state the reasons for the use of the urgency procedure. 

Either  the  European  Parliament  or  the  Council  may  object  to  a  delegated  act  in 
accordance  with  the  procedure  referred  to  in  Article  89.  In  such  a  case,  the 
Commission  shall  repeal  the  act  without  delay  following  the  notification  of  the 
decision to object by the European Parliament or the Council.  

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Article 91 
Amendments to Directive 2001/83/EC 

In Annex I of Directive 2001/83/EC, point 12 of Section 3.2. is replaced by the following:  

‘(12)  Where  a  product  is  governed  by  this  Directive  in  accordance  with  the  second 
subparagraph of Article 1(4) or the second subparagraph of Article 1(5) of Regulation (EU) 
[…/…]  on  medical  devices55,  the  marketing  authorisation  dossier  shall  include,  where 
available, the results of the assessment of the conformity of the device part with the relevant 
general safety and performance requirements of Annex I of that Regulation contained in the 
manufacturer’s  EU  declaration  of  conformity  or  the  relevant  certificate  issued  by  a  notified 
body allowing the manufacturer to affix a CE marking to the medical device.  

If the dossier does not include the results of the conformity assessment referred to in the first 
subparagraph and where for the conformity assessment of the device, if used separately, the 
involvement of a notified body is  required in accordance with Regulation (EU) […/…],  the 
authority shall require the applicant to provide an opinion on the conformity of the device part 
with the relevant general safety and performance requirements of Annex I of that Regulation 
issued by a notified body designated in accordance with that Regulation for the type of device 
in question, unless the authority is advised by its experts for medical devices that involvement 
of a notified body is not required.’ 

Article 92 
Amendments to Regulation (EC) No 178/2002 

In the third subparagraph of Article 2 of Regulation (EC) No 178/2002, the following point (i) 
is added:  

‘(i) medical devices within the meaning of Regulation (EU) […/…]56.’ 

Article 93 
Amendments to Regulation (EC) No 1223/2009 

In Article 2 of Regulation (EC) No 1223/2009, the following paragraph is added:  

‘4. In accordance with the regulatory procedure referred to in Article 32(2), the Commission 
may, at the request of a Member State or on its own initiative, adopt the necessary measures 
to determine whether or not a specific product or group of products falls within the definition 
‘cosmetic product’.’  

55 
56 

OJ L […], […], p. […]. 
OJ L […], […], p. […]. 

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1. 

2. 

3. 

4. 

5. 

6. 

7. 

Article 94 
Transitional provisions  

From  the  date  of  application  of  this  Regulation  any  publication  of  a  notification  in 
respect of a notified body in accordance with Directives 90/385/EEC and 93/42/EEC 
shall become void.  

Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 
93/42/EEC prior to the entry into force of this Regulation shall remain valid until the 
end  of  the  period  indicated  on  the  certificate,  except  for  certificates  issued  in 
accordance  with  Annex  4  of  Directive  90/385/EEC  or  Annex  IV  of  Directive 
93/42/EEC  which  shall  become  void  at  the  latest  two  years  after  the  date  of 
application of this Regulation.  

Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 
93/42/EEC after the entry into force of this Regulation shall become void at the latest 
two years after the date of application of this Regulation.  

By  way  of  derogation  from  Directives  90/385/EEC  and  93/42/EEC,  devices  which 
comply  with  this  Regulation  may  be  placed  on  the  market  before  its  date  of 
application.  

By  way  of  derogation  from  Directives  90/385/EEC  and  93/42/EEC,  conformity 
assessment  bodies  which  comply  with  this  Regulation  may  be  designated  and 
notified  before  its  date  of  application.  Notified  bodies  which  are  designated  and 
notified  in  accordance  with  this  Regulation  may  apply  the  conformity  assessment 
procedures laid down in this Regulation and issue certificates in accordance with this 
Regulation before its date of application. 

By way of derogation from Article 10a and point (a) of Article 10b(1) of Directive 
90/385/EEC  and  Article  14(1)  and  (2)  and  points  (a)  and  (b)  of  Article  14a(1)  of 
Directive  93/42/EEC,  manufacturers,  authorised  representatives,  importers  and 
notified  bodies  who,  during  the  period  from  [date  of  application]  until  [18  months 
after date of application], comply with Article 25(2) and (3) and Article 45(4) of this 
Regulation shall be considered to comply with the laws and regulations adopted by 
Member  States 
in  accordance  with,  respectively,  Article  10a  of  Directive 
90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC and with, respectively, 
point (a) of Article 10b(1) of Directive 90/385/EEC or points (a) and (b) of Article 
14a(1) of Directive 93/42/EEC as specified in Commission Decision 2010/227/EU. 

Authorisations granted by competent authorities of the Member States in accordance 
with Article 9(9) of Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC 
shall keep the validity indicated in the authorisation.  

Devices  falling  within  the  scope  of  this  Regulation  in  accordance  with  point  (e)  of 
Article  1(2)  which  have  been  legally  placed  on  the  market  or  put  into  service  in 
accordance  with  the  rules  in  force  in  the  Member  States  prior  to  the  application  of 
this Regulation may continue to be placed on the market and put into service in the 
Member States concerned.  

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8. 

Clinical investigations which have started to be conducted in accordance with Article 
10  of  Directive  90/385/EEC  or  Article  15  of  Directive  93/42/EEC  prior  to  the 
application of this Regulation may continue to be conducted. As of the application of 
this  Regulation,  however,  the  reporting  of  serious  adverse  events  and  device 
deficiencies shall be carried out in accordance with this Regulation.  

Article 95 
Evaluation 

No  later  than  seven  years  after  the  date  of  application,  the  Commission  shall  assess  the 
application  of  this  Regulation  and  establish  an  evaluation  report  on  the  progress  towards 
achievement of the objectives of the Regulation including an assessment of resources required 
to implement this Regulation.  

Article 96 
Repeal 

Council  Directives  90/385/EEC  and  93/42/EEC  are  repealed  with  effect  from  [date  of 
application  of  this  Regulation],  with  the  exception  of  Article  10a  and  point  (a)  of  Article 
10b(1)  of  Directive  90/385/EEC  and  Article  14(1)  and  (2)  and  points  (a)  and  (b)  of  Article 
14a(1) of Directive 93/42/EEC which are repealed with effect from [18 months after date of 
application]. 

References  to  the  repealed  Council  Directives  shall  be  understood  as  reference  to  this 
Regulation  and  shall  be  read  in  accordance  with  the  correlation  table  laid  down  in  Annex 
XVI. 

Article 97 
Entry into force and date of application 

1. 

2. 

3. 

This Regulation shall enter into force on the twentieth day after its publication in the 
Official Journal of the European Union. 

It shall apply from [three years after entry into force]. 

By way of derogation from paragraph 2 the following shall apply: 

(a)  Article 25(2) and (3) and Article 45(4) shall apply from [18 months after date 

of application referred to in paragraph 2]; 

(b)  Articles 28 to 40 and Article 78 shall apply from [six months after entry into 
force]. However, prior to [date of application as referred to in paragraph 2], the 
obligations on notified bodies emanating from the provisions in Articles 28 to 
40 shall apply only to those bodies which submit an application for notification 
in accordance with Article 31 of this Regulation.  

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

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Done at Brussels, 26.9.2012 

For the European Parliament 
The President 

For the Council 
The President 

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GENERAL SAFETY AND PERFORMANCE REQUIREMENTS 

ANNEX I 

I. 

1. 

2. 

3. 

General requirements  

Devices shall achieve the performance intended by the manufacturer and be designed 
and  manufactured  in  such  a  way  that,  during  normal  conditions  of  use,  they  are 
suitable for their intended purpose, taking into account the generally acknowledged 
state  of  the  art.  They  shall  not  compromise  the  clinical  condition  or  the  safety  of 
patients,  or  the  safety  and  health  of  users  or,  where  applicable,  other  persons, 
provided that any risks which may be associated with their use constitute acceptable 
risks when weighed against the benefits to the patient and are compatible with a high 
level of protection of health and safety. 

This shall include:  

– 

– 

reducing as far as possible the risk of use error due to ergonomic features of the 
device and the environment in which the device is intended to be used (design 
for patient safety), and  

consideration  of  the  technical  knowledge,  experience,  education  and  training, 
and  the  medical  and  physical  conditions  of  intended  users  (design  for  lay, 
professional, disabled or other users).  

The  solutions  adopted  by  the  manufacturer  for  the  design  and  manufacture  of  the 
devices  shall  conform  to  safety  principles,  taking  account  of  the  generally 
acknowledged  state  of  the  art.  To  reduce  risks,  the  manufacturer  shall  manage  the 
risks  so  that  the  residual  risk  associated  with  each  hazard  as  well  as  the  overall 
residual  risk  is  judged  acceptable.  The  manufacturer  shall  apply  the  following 
principles in the priority order listed: 

(a) 

(b) 

(c) 

identify known or foreseeable hazards and estimate the associated risks arising 
from the intended use and foreseeable misuse; 

eliminate  risks  as  far  as  possible  through  inherently  safe  design  and 
manufacture; 

reduce  as  far  as  possible  the  remaining  risks  by  taking  adequate  protection 
measures, including alarms; and 

(d)  provide training to users and/or inform users of any residual risks. 

The characteristics and performances of the device shall not be adversely affected to 
such  a  degree  that  the  health  or  safety  of  the  patient  or  the  user  and,  where 
applicable,  of  other  persons  are  compromised  during  the  lifetime  of  the  device,  as 
indicated by the manufacturer, when the device is subjected to the stresses which can 
occur  during  normal  conditions  of  use  and  has  been  properly  maintained  in 
accordance with the manufacturer’s instructions. When no lifetime is stated, the same 

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4. 

5. 

6. 

II. 

7. 

7.1. 

7.2. 

7.3. 

applies  for  the  lifetime  reasonably  to  be  expected  of  a  device  of  that  kind,  having 
regard to the intended purpose and the anticipated use of the device.  

Devices  shall  be  designed,  manufactured  and  packaged  in  such  a  way  that  their 
characteristics  and  performances  during  their  intended  use  will  not  be  adversely 
affected by transport and storage conditions (for example, fluctuations of temperature 
and  humidity)  taking  account  of  the  instructions  and  information  provided  by  the 
manufacturer. 

All  known  and  foreseeable  risks,  and  any  undesirable  side-effects,  shall  be 
minimised and be acceptable when weighed against the benefits to the patient of the 
achieved performance of the device during normal conditions of use. 

For devices listed in Annex XV for which the manufacturer does not claim a medical 
purpose, the general requirements set out in Sections 1 and 5 shall be understood that 
the device, when used under the conditions and for the purposes intended, shall not 
present  any  risk  or  only  the  minimum  acceptable  risks  related  to  the  product’s  use 
which  is  consistent  with  a  high  level  of  protection  for  the  safety  and  health  of 
persons. 

Requirements regarding design and construction  

Chemical, physical and biological properties 

The  devices  shall  be  designed  and  manufactured  in  such  a  way  as  to  ensure  the 
characteristics  and  performance  referred  to  in  Chapter  I  ‘General  Requirements’. 
Particular attention shall be paid to: 

(a) 

(b) 

the  choice  of  materials  used,  particularly  as  regards  toxicity  and,  where 
appropriate, flammability; 

the compatibility between the materials used and biological tissues, cells, and 
body fluids taking account of the intended purpose of the device; 

(c)  where  appropriate,  the  results  of  biophysical  or  modelling  research  whose 

validity has been demonstrated beforehand;  

(d) 

the  choice  of  materials  used,  reflecting,  where  appropriate,  matters  such  as 
hardness, wear and fatigue strength. 

The  devices  shall  be  designed,  manufactured  and  packaged  in  such  a  way  as  to 
minimise the risk posed by contaminants and residues to patients, taking account of 
the  intended  purpose  of  the  device,  and  to  the  persons  involved  in  the  transport, 
storage  and  use  of  the  devices.  Particular  attention  shall  be  paid  to  tissues  exposed 
and to the duration and frequency of exposure. 

The devices shall be designed and manufactured in such a way that they can be used 
safely with the materials and substances, including gases, with which they enter into 
contact  during  their  normal  use  or  during  routine  procedures;  if  the  devices  are 
intended to administer medicinal products they shall be designed and manufactured 
in such a way as to be compatible with the medicinal products concerned according 
to  the  provisions  and  restrictions  governing  these  medicinal  products  and  that  both 

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7.4. 

the  performance  of  the  medicinal  products  and  of  the  devices  are  maintained  in 
accordance with their respective indications and intended use. 

The devices shall be designed and manufactured in such a way as to reduce as far as 
possible and appropriate the risks posed by substances that may leach or leak from 
the  device.  Special  attention  shall  be  given  to  substances  which  are  carcinogenic, 
mutagenic  or  toxic  to  reproduction,  in  accordance  with  Part  3  of  Annex  VI  to 
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 
December  2008  on  classification,  labelling  and  packaging  of  substances  and 
mixtures,  amending  and  repealing  Directives  67/548/EEC  and  1999/45/EC,  and 
amending  Regulation  (EC)  No  1907/200657,  and  to  substances  having  endocrine 
disrupting properties for which there is scientific evidence of probable serious effects 
to human health and which are identified in accordance with the procedure set out in 
Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH)58. 

If devices, or parts thereof, that are intended  

– 

– 

– 

to be invasive devices and to come into contact with the body of the patient for 
short- or long-term, or  

to (re)administer medicines, body liquids or other substances, including gases, 
to/from the body, or  

to transport or store such medicines, body fluids or substances, including gases, 
to be (re)administered to the body  

contain,  in  a  concentration  of  0.1%  by  mass  of  the  plasticised  material  or  above, 
phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction of 
category  1A  or  1B  in  accordance  with  Part  3  of  Annex  VI  to  Regulation  (EC)  No 
1272/2008,  these  devices  shall  be  labelled  on  the  device  itself  and/or  on  the 
packaging  for  each  unit  or,  where  appropriate,  on  the  sales  packaging  as  devices 
containing  phthalates.  If  the  intended  use  of  such  devices  includes  treatment  of 
children or treatment of pregnant or nursing women, the manufacturer shall provide a 
specific justification for the use of these substances with regard to compliance with 
the  general  safety  and  performance  requirements,  in  particular  of  this  paragraph, 
within the technical documentation and, within the instructions for use, information 
on  residual  risks  for  these  patient  groups  and,  if  applicable,  on  appropriate 
precautionary measures. 

7.5. 

Devices  shall  be  designed  and  manufactured  in  such  a  way  as  to  reduce  as  far  as 
possible  and  appropriate  risks  posed  by  the  unintentional  ingress  or  egress  of 
substances into or from the device taking into account the device and the nature of 
the environment in which it is intended to be used. 

7.6. 

The  devices  shall  be  designed  and  manufactured  in  such  a  way  as  to  reduce  to  a 
minimum the risks linked to the size and the properties of particles used. Special care 

57 
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OJ L 353, 31.12.2008, p. 1. 
OJ L 136, 29.5.2007, p.3. 

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shall be applied when devices contain or consist of nanomaterial that can be released 
into the patient’s or user's body. 

8. 

Infection and microbial contamination 

8.1. 

The  devices  and  manufacturing  processes  shall  be  designed  in  such  a  way  as  to 
eliminate or to reduce as far as possible the risk of infection to patients, users and, 
where applicable, other persons. The design shall: 

(a) 

allow easy handling, 

and, where necessary, 

(b) 

reduce as far as possible and appropriate any microbial leakage from the device 
and/or microbial exposure during use, 

(c)  prevent microbial contamination of the device or specimen. 

Devices  labelled  as  having  a  special  microbiological  state  shall  be  designed, 
manufactured and packaged to ensure that they remain so when placed on the market 
and  remain  so  under  the  transport  and  storage  conditions  specified  by  the 
manufacturer. 

Devices delivered in a sterile state shall be designed, manufactured and packaged in 
a non-reusable pack, and/or according to appropriate procedures, to ensure that they 
are  sterile  when  placed  on  the  market  and  remain  sterile,  under  the  transport  and 
storage  conditions  indicated  by  the  manufacturer,  until  the  protective  packaging  is 
damaged or opened.  

Devices  labelled  either  as  sterile  or  as  having  a  special  microbiological  state  shall 
have  been  processed,  manufactured  and,  if  applicable,  sterilised  by  appropriate, 
validated methods. 

Devices  intended  to  be  sterilised  shall  be  manufactured  in  appropriately  controlled 
(e.g. environmental) conditions. 

Packaging systems for non-sterile devices shall maintain the integrity and cleanliness 
of the product and, if the devices are to be sterilised prior to use, minimise the risk of 
microbial  contamination;  the  packaging  system  shall  be  suitable  taking  account  of 
the method of sterilisation indicated by the manufacturer. 

The  labelling  of  the  device  shall  distinguish  between  identical  or  similar  products 
placed on the market in both sterile and non-sterile condition. 

Devices  incorporating  a  substance  considered  to  be  a  medicinal  product  and 
devices  composed  of  substances  or  combination  of  substances  intended  to  be 
ingested, inhaled or administered rectally or vaginally  

In the case of devices referred to in the first subparagraph of Article 1(4), the quality, 
safety and usefulness of the substance which, if used separately, would be considered 
to be a medicinal product within the meaning of Article 1 of Directive 2001/83/EC, 
shall  be  verified  by  analogy  with  the  methods  specified  in  Annex  I  to  Directive 

8.2. 

8.3. 

8.4. 

8.5. 

8.6. 

8.7. 

9. 

9.1. 

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2001/83/EC, as laid down in the applicable conformity assessment procedure in this 
Regulation. 

9.2. 

Devices that are composed of substances or combination of substances intended to be 
ingested,  inhaled  or  administered  rectally  or  vaginally  and  that  are  absorbed  by  or 
dispersed  in  the  human  body  shall  comply,  by  analogy,  with  the  relevant 
requirements laid down in Annex I to Directive 2001/83/EC. 

10. 

Devices incorporating materials of biological origin 

10.1. 

For  devices  manufactured  utilising  tissues  or  cells,  or  their  derivatives,  of  human 
origin which are covered by this Regulation in accordance with point (e) of Article 
1(2) the following applies:  

(a)  Donation, procurement and testing of tissues and cells of human origin used for 
the  manufacture  of  devices  shall  be  made  in  accordance  with  Directive 
2004/23/EC. 

(b)  The processing, preservation and any other handling of those tissues and cells 
shall  be  carried  out  so  as  to  provide  optimal  safety  for  patients,  users  and, 
where applicable, other persons. In particular, safety with regard to viruses and 
other  transmissible  agents  shall  be  addressed  by  implementation  of  validated 
methods  of  elimination  or  inactivation  in  the  course  of  the  manufacturing 
process.  

(c) 

It  shall  be  ensured  that  the  traceability  system  for  devices  manufactured 
utilising  those  human  tissues  or  cells  is  complementary  and  compatible  with 
the  traceability  and  data  protection  requirements  laid  down  in  Directive 
2004/23/EC  and  in  Directive  2002/98/EC  of  the  European  Parliament  and  of 
the Council of 27 January 2003 setting standards of quality and safety for the 
collection,  testing,  processing,  storage  and  distribution  of  human  blood  and 
blood components and amending Directive 2001/83/EC59.  

10.2. 

For  devices  manufactured  utilising  tissues  or  cells,  or  their  derivatives,  of  animal 
origin which are non-viable or rendered non-viable the following applies: 

(a)  Where  feasible  taking  into  account  the  animal  species,  tissues  and  cells  of 
animal  origin  shall  originate  from  animals  that  have  been  subjected  to 
veterinary  controls  that  are  adapted  to  the  intended  use  of  the  tissues. 
Information on the geographical origin of the animals shall be retained. 

(b)  Processing,  preservation,  testing  and  handling  of  tissues,  cells  and  substances 
of animal origin shall be carried out so as to provide optimal safety for patients, 
users and, where applicable, other persons. In particular safety with regard to 
viruses and other transmissible agents shall be addressed by implementation of 
validated  methods  of  elimination  or  viral  inactivation  in  the  course  of  the 
manufacturing process. 

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(c) 

In the case of devices manufactured utilising tissues or cells of animal origin as 
referred  to  in  Commission  Regulation  (EU)  No  722/2012  of  8  August  2012 
concerning  particular  requirements  as  regards  the  requirements  laid  down  in 
Council  Directives  90/385/EEC  and  93/42/EEC  with  respect  to  active 
implantable  medical  devices  and  medical  devices  manufactured  utilising 
tissues  of  animal  origin60,  the  particular  requirements  laid  down  in  that 
Regulation shall apply. 

10.3. 

For  devices  manufactured  utilising  other  non-viable  biological  substances  the 
following applies:  

In the case of biological substances other than those referred to in Sections 10.1. and 
10.2., the processing, preservation, testing and handling of those substances shall be 
carried out so as to provide optimal safety for patients, users and, where applicable, 
other  persons.  In  particular,  safety  with  regard  to  viruses  and  other  transmissible 
agents shall be addressed by implementation of validated methods of elimination or 
inactivation in the course of the manufacturing process. 

11. 

Interaction of devices with their environment 

11.1. 

If the device is intended for use in combination with other devices or equipment the 
whole  combination,  including  the  connection  system  shall  be  safe  and  shall  not 
impair the specified performance of the devices. Any restrictions on use applying to 
such combinations shall be indicated on the label and/or in the instructions for use. 
Connections which the user has to handle, such as fluid, gas transfer or mechanical 
coupling, shall be designed and constructed in such a way as to minimize all possible 
risks from incorrect connection. 

11.2.  Devices shall be designed and manufactured in such a way as to remove or reduce as 

far as possible and appropriate: 

(a) 

(b) 

(c) 

the risk of injury to the patient, user or other persons in connection with their 
physical and ergonomic features; 

the  risk  of  use  error  due  to  the  ergonomic  features,  human  factors  and  the 
environment in which the device is intended to be used; 

reasonably 

risks  connected  with 
influences  or 
environmental  conditions,  such  as  magnetic  fields,  external  electrical  and 
electromagnetic  effects,  electrostatic  discharge,  radiation  associated  with 
diagnostic  or 
temperature, 
therapeutic  procedures,  pressure,  humidity, 
variations in pressure and acceleration or radio signal interferences; 

foreseeable  external 

(d) 

the risks associated with the use of the device when it comes into contact with 
materials,  liquids,  and  substances,  including  gases,  to  which  it  is  exposed 
during normal conditions of use; 

(e) 

the risk associated with the possible negative interaction between software and 
the environment within which it operates and interacts; 

60 

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(f) 

the risks of accidental ingress of substances into the device; 

(g) 

(h) 

the  risks  of  reciprocal  interference  with  other  devices  normally  used  in  the 
investigations or for the treatment given; 

risks  arising  where  maintenance  or  calibration  are  not  possible  (as  with 
implants), from ageing of materials used or loss of accuracy of any measuring 
or control mechanism. 

11.3.  Devices shall be designed and manufactured in such a way as to minimise the risks 
of  fire  or  explosion  during  normal  use  and  in  single  fault  condition.  Particular 
attention shall be paid to devices whose intended purpose includes exposure to or use 
in  association  with  flammable  substances  or  substances  which  could  cause 
combustion. 

11.4.  Devices  shall  be  designed  and  manufactured  in  such  a  way  that  adjustment, 
calibration,  and  maintenance,  where  such  is  necessary  to  achieve  the  performances 
intended, can be done safely. 

11.5.  Devices that are intended to be operated together with other devices or products shall 
be designed and manufactured in such as way that the interoperability is reliable and 
safe. 

11.6.  Any  measurement,  monitoring  or  display  scale  shall  be  designed  in  line  with 
ergonomic principles, taking account of the intended purpose of the device. 

11.7.  Devices  shall  be  designed  and  manufactured  in  such  a  way  as  to  facilitate  the  safe 
disposal  of  the  device  and/or  of  any  waste  substances  by  the  user,  patient  or  other 
person. 

12. 

Devices with a diagnostic or measuring function 

12.1.  Diagnostic  devices  and  devices  with  a  measuring  function,  shall  be  designed  and 
manufactured in such a way as to provide sufficient accuracy, precision and stability 
for  their  intended  purpose,  based  on  appropriate  scientific  and  technical  methods. 
The limits of accuracy shall be indicated by the manufacturer. 

12.2. 

The  measurements  made  by  devices  with  a  measuring  function  and  expressed  in 
legal units shall conform to the provisions of Council Directive 80/181/EEC61. 

13. 

Protection against radiation 

13.1.  General 

(a)  Devices shall be designed and manufactured and packaged in such a way that 
exposure of patients, users and other persons to any emitted radiation shall be 
reduced  as  far  as  possible  and  appropriate,  compatible  with  the  intended 
purpose, whilst not restricting the application of appropriate specified levels for 
therapeutic and diagnostic purposes. 

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(b)  The  operating  instructions  for  devices  emitting  radiation  shall  give  detailed 
information  as  to  the  nature  of  the emitted  radiation,  means  of  protecting  the 
patient  and  the  user  and  on  ways  of  avoiding  misuse  and  of  eliminating  the 
risks inherent in installation. 

13.2. 

Intended radiation 

(a)  Where devices are designed to emit hazardous, or potentially hazardous, levels 
of  visible  and/or  invisible  radiation  necessary  for  a  specific  medical  purpose 
the  benefit  of  which  is  considered  to  outweigh  the  risks  inherent  in  the 
emission, it shall be possible for the user to control the emissions. Such devices 
shall  be  designed  and  manufactured  to  ensure  reproducibility  of  relevant 
variable parameters within an acceptable tolerance. 

(b)  Where  devices  are  intended  to  emit  potentially  hazardous,  visible  and/or 
invisible  radiation,  they  shall  be  fitted,  where  possible,  with  visual  displays 
and/or audible warnings of such emissions. 

13.3.  Unintended radiation 

Devices shall be designed and manufactured in such a way that exposure of patients, 
users and other persons to the emission of unintended, stray or scattered radiation is 
reduced as far as possible and appropriate. 

13.4. 

Ionising radiation 

(a)  Devices intended to emit ionising radiation shall be designed and manufactured 
in  such  a  way  as  to  ensure  that,  where  possible,  the  quantity,  geometry  and 
energy  distribution  (or  quality)  of  radiation  emitted  can  be  varied  and 
controlled taking into account the intended use. 

(b)  Devices  emitting  ionising  radiation  intended  for  diagnostic  radiology  shall  be 
designed  and  manufactured  in  such  a  way  as  to  achieve  appropriate  image 
and/or  output  quality  for  the  intended  medical  purpose  whilst  minimising 
radiation exposure of the patient and user. 

(c)  Devices emitting ionising radiation, intended for therapeutic radiology shall be 
designed and manufactured in such a way as to enable reliable monitoring and 
control  of  the  delivered  dose,  the  beam  characteristics  in  terms  of  type  of 
radiations, energy and, where appropriate, energy distribution. 

14. 

Software incorporated in devices and standalone software 

14.1.  Devices  that  incorporate  electronic  programmable  systems,  including  software,  or 
standalone  software  that  are  devices  in  themselves,  shall  be  designed  to  ensure 
repeatability, reliability and performance according to the intended use. In the event 
of a single fault condition, appropriate means shall be adopted to eliminate or reduce 
as far as possible and appropriate consequent risks. 

14.2. 

For devices that incorporate software or for standalone software that are devices in 
themselves, the software shall be developed and manufactured according to the state 

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of  the  art  taking  into  account  the  principles  of  development  life  cycle,  risk 
management, verification and validation. 

14.3. 

Software referred to in this Section that are intended to be used in combination with 
mobile computing platforms shall be designed and manufactured taking into account 
the specific features of the mobile platform (e.g. size and contrast ratio of the screen) 
and the external factors related to their use (varying environment as regards to level 
of light or noise). 

15. 

Active devices and devices connected to them  

15.1. 

For active devices, in the event of a single fault condition, appropriate means shall be 
adopted to eliminate or reduce as far as possible and appropriate consequent risks. 

15.2.  Devices where the safety of the patients depends on an internal power supply shall be 

equipped with a means of determining the state of the power supply. 

15.3.  Devices where the safety of the patients depends on an external power supply shall 

include an alarm system to signal any power failure. 

15.4.  Devices  intended  to  monitor  one  or  more  clinical  parameters  of  a  patient  shall  be 
equipped with appropriate alarm systems to alert the user of situations which could 
lead to death or severe deterioration of the patient's state of health. 

15.5.  Devices  shall  be  designed  and  manufactured  in  such  a  way  as  to  reduce  as  far  as 
possible  and  appropriate  the  risks  of  creating  electromagnetic  interference  which 
could  impair  the  operation  of  this  or  other  devices  or  equipment  in  the  intended 
environment. 

15.6.  Devices shall be designed and manufactured in such a way as to provide an adequate 
level of intrinsic immunity to electromagnetic disturbance to enable them to operate 
as intended. 

15.7.  Devices  shall  be  designed  and  manufactured  in  such  a  way  as  to  avoid,  as  far  as 
possible, the risk of accidental electric shocks to the patient, user or any other person, 
both during normal use of the device and in the event of a single fault condition in 
the  device,  provided  the  device  is  installed  and  maintained  as  indicated  by  the 
manufacturer. 

16. 

Protection against mechanical and thermal risks 

16.1.  Devices shall be designed and manufactured in such a way as to protect the patient 
and  user  against  mechanical  risks  connected  with,  for  example,  resistance  to 
movement, instability and moving parts. 

16.2.  Devices shall be designed and manufactured in such a way as to reduce to the lowest 
possible  level  the  risks  arising  from  vibration  generated  by  the  devices,  taking 
account  of  technical  progress  and  of  the  means  available  for  limiting  vibrations, 
particularly at source, unless the vibrations are part of the specified performance. 

16.3.  Devices shall be designed and manufactured in such a way as to reduce to the lowest 
possible  level  the  risks  arising  from  the  noise  emitted,  taking  account  of  technical 

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progress and of the means available to reduce noise, particularly at source, unless the 
noise emitted is part of the specified performance. 

16.4. 

16.5. 

Terminals  and  connectors  to  the  electricity,  gas  or  hydraulic  and  pneumatic  energy 
supplies  which  the  user  or  other  person  has  to  handle  shall  be  designed  and 
constructed in such a way as to minimise all possible risks. 

Errors  likely  to  be  made  when  fitting  or  refitting,  or  connecting  or  reconnecting, 
certain  parts  before  or  during  use  which  could  be  a  source  of  risk  must  be  made 
impossible  by  the  design  and  construction  of  such  parts  or,  failing  this,  by 
information given on the parts themselves and/or their housings. 

The  same  information  must  be  given  on  moving  parts  and/or  their  housings  where 
the direction of movement needs to be known in order to avoid a risk. 

16.6.  Accessible parts of the devices (excluding the parts or areas intended to supply heat 
or  reach  given  temperatures)  and  their  surroundings  shall  not  attain  potentially 
dangerous temperatures under normal conditions of use. 

17. 

Protection against the risks posed to the patient or user by supplied energy or 
substances 

17.1.  Devices  for  supplying  the  patient  with  energy  or  substances  shall  be  designed  and 
constructed  in  such  a  way  that  the  delivered  amount  can  be  set  and  maintained 
accurately enough to assure the safety of the patient and of the user. 

17.2.  Devices  shall  be  fitted  with  the  means  of  preventing  and/or  indicating  any 
inadequacies  in  the  delivered  amount  which  could  pose  a  danger.  Devices  shall 
incorporate  suitable  means  to  prevent,  as  far  as  possible,  the  accidental  release  of 
dangerous levels of energy or substances from an energy and/or substance source. 

17.3. 

The function of the controls and indicators shall be clearly specified on the devices. 
Where a device bears instructions required for its operation or indicates operating or 
adjustment  parameters  by  means  of  a  visual  system,  such  information  shall  be 
understandable to the user and, as appropriate, the patient. 

18. 

Protection  against  the  risks  posed  by  medical  devices  intended  by  the 
manufacturer for use by lay persons  

18.1.  Devices  for  use  by  lay  persons  shall  be  designed  and  manufactured  in  such  a  way 
that  they  perform  appropriately  for  their  intended  purpose  taking  into  account  the 
skills  and  the  means  available  to  lay  persons  and  the  influence  resulting  from 
variation  that  can  reasonably  be  anticipated  in  the  lay  person’s  technique  and 
environment. The information and instructions provided by the manufacturer shall be 
easy for the lay person to understand and apply. 

18.2.  Devices for use by lay persons shall be designed and manufactured in such a way as 

to  

– 

ensure  that  the  device  is  easy  to  use  by  the  intended  user  at  all  stages  of  the 
procedure, and 

EN 

110 

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– 

reduce as far as possible the risk of error by the intended user in the handling of 
the device and, if applicable, in the interpretation of the results. 

18.3.  Devices for use by lay persons shall, where reasonably possible, include a procedure 

by which the lay person 

– 

– 

can verify that, at the time of use, the device will perform as intended by the 
manufacturer, and 

if applicable, is warned if the device has failed to provide a valid result. 

III. 

Requirements regarding the information supplied with the device 

19. 

Label and instructions for use 

19.1.  General requirements regarding the information supplied by the manufacturer  

Each device shall be accompanied by the information needed to identify the device 
and  its manufacturer, and communicate  safety and performance related information 
to the user, professional or lay, or other person, as appropriate. Such information may 
appear on the device itself, on the packaging or in the instructions for use, taking into 
account the following:  

(a)  The  medium,  format,  content,  legibility,  and  location  of  the  label  and 
instructions  for  use  shall  be  appropriate  to  the  particular  device,  its  intended 
purpose and the technical knowledge, experience, education or training of the 
intended  user(s).  In  particular,  instructions  for  use  shall  be  written  in  terms 
readily understood by the intended user and, where appropriate, supplemented 
with  drawings  and  diagrams.  Some  devices may include separate information 
for the professional user and the lay person. 

(b)  The information required on the label shall be provided on the device itself. If 
this is not practicable or appropriate, some or all of the information may appear 
on the packaging for each unit, and/or on the packaging of multiple devices. 

Where multiple devices are supplied to a single user and/or location, a single 
copy of the instructions for use may be provided if so agreed by the purchaser 
who in any case may request further copies to be provided.  

(c)  For  devices  of  class  I  and  IIa,  instructions  for  use  are  not  needed  or  may  be 
abbreviated  if  the  device  can  be  used  safely  and  as  intended  by  the 
manufacturer without any such instructions for use. 

(d)  Labels shall be provided in a human-readable format but may be supplemented 
by  machine-readable  forms,  such  as  radio-frequency  identification  (RFID)  or 
bar codes. 

(e) 

Instructions  for  use  may  be  provided  to  the  user  in  non-paper  format  (e.g. 
electronic)  to  the  extent  and  under  the  conditions  set  out  in  Commission 

EN 

111 

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Regulation  (EU)  No  207/2012  on  electronic  instructions  for  use  of  medical 
devices62.  

(f)  Residual risks which are required to be communicated to the user and/or other 
person  shall  be  included  as  limitations,  contraindications,  precautions  or 
warnings in the information supplied by the manufacturer. 

(g)  Where  appropriate,  this  information  should  take  the  form  of  internationally 
recognised symbols. Any symbol or identification colour used shall conform to 
the  harmonised  standards  or  CTS.  In  areas  for  which  no  standards  or  CTS 
exist, the symbols and colours shall be described in the documentation supplied 
with the device.  

19.2. 

Information on the label  

The label shall bear the following particulars: 

(a)  The name or trade name of the device.  

(b)  The details strictly necessary for a user to identify the device, the contents of 
the packaging and, where it is not obvious for the user, the intended purpose of 
the device. 

(c)  The name, registered trade name or registered trade mark of the manufacturer 
and the address of his registered place of business at which he can be contacted 
and his location be established. 

(d)  For imported devices, the name, registered trade name or registered trade mark 
of the authorised representative established within the Union and the address of 
his registered place of business at which he can be contacted and his location 
be established.  

(e)  Where applicable, an indication that the device contains or incorporates  

– 

– 

– 

a medicinal substance, including a human blood or plasma derivative, or 

tissues or cells, or their derivatives, of human origin, or 

tissues  or  cells,  or  their  derivatives,  of  animal  origin  as  referred  to  in 
Commission Regulation (EU) No 722/2012. 

(f)  Where  applicable,  an  indication  that  the  device  incorporates  or  consists  of 
nanomaterial  unless  the  nanomaterial  is  encapsulated  or  bound  in  such  a 
manner  that  it  cannot  be  released  into  the  patient’s  or  user's  body  when  the 
device is used within its intended purpose. 

(g)  The batch code/lot number or the serial number of the device preceded by the 
word LOT or SERIAL NUMBER or an equivalent symbol, as appropriate. 

62 

OJ L 72, 10.3.2012, p. 28. 

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(h)  Where applicable, the unique device identification (UDI). 

(i)  An  unambiguous  indication  of  the  date  until  when  the  device  may  be  used 

safely, expressed at least as the year and month, where this is relevant.  

(j)  Where there is no indication of the date until when it may be used safely, the 
year of manufacture. This year of manufacture may be included as part of the 
batch or serial number, provided the date is clearly identifiable. 

(k)  An indication of any special storage and/or handling condition that applies. 

(l) 

If  the  device  is  supplied  sterile,  an  indication  of  its  sterile  state  and  the 
sterilisation method. 

(m)  Warnings or precautions to be taken that need to be brought to the immediate 
attention of the user of the device as relevant, and to any other person where 
appropriate. This information may be kept to a minimum in which case more 
detailed information should appear in the instructions for use. 

(n) 

(o) 

If  the  device  is  intended  for  single  use,  an  indication  of  that  fact.  A 
manufacturer's indication of single use shall be consistent across the Union. 

If the device is a single use device that has been reprocessed, an indication of 
that  fact,  the  number  of  reprocessing  cycles  already  performed,  and  any 
limitation as regards the number of reprocessing cycles.  

(p) 

If the device is custom made, an indication of that fact. 

(q) 

If  the  device  is  intended  for  clinical  investigation  only,  an  indication  of  that 
fact. 

19.3. 

Information in the instructions for use 

The instructions for use shall contain the following particulars: 

(a)  The particulars referred to in points 19.2. a), c), e), f), k), l) and n). 

(b)  The device’s intended purpose including the intended user (e.g. professional or 

lay person), as appropriate.  

(c)  The performance of the device intended by the manufacturer. 

(d)  Any  residual  risks,  contraindications  and  any  expected  and  foreseeable 
undesirable side-effects, including information to be conveyed to the patient in 
this regard. 

(e)  Specifications  the  user  requires  to  use  the  device  appropriately,  e.g.  if  the 
device has a measuring function, the degree of accuracy claimed for it.  

(f)  Details of any preparatory treatment or handling of the device before it is ready 

for use (e.g. sterilisation, final assembly, calibration, etc.). 

EN 

113 

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(g)  Any  requirements  for  special  facilities,  or  special  training,  or  particular 

qualifications of the device user and/or other persons. 

(h)  The information needed to verify whether the device is properly installed and is 
ready  to  perform  safely  and  as  intended  by  the  manufacturer,  together  with, 
where relevant: 

– 

– 

– 

– 

details  of  the  nature,  and  frequency,  of  preventative  and  regular 
maintenance, and of any preparatory cleaning or disinfection; 

identification of any consumable components and how to replace them; 

information  on  any  necessary  calibration  to  ensure  that  the  device 
operates properly and safely during its intended lifetime; 

methods  of  eliminating  the  risks  encountered  by  persons  involved  in 
installing, calibrating or servicing devices. 

If  the  device  is  supplied  sterile,  instructions  in  the  event  of  the  sterile 
packaging being damaged before use.  

If the device is supplied non-sterile with the intention that it is sterilised before 
use, the appropriate instructions for sterilisation. 

If  the  device  is  reusable,  information  on  the  appropriate  processes  to  allow 
reuse, including cleaning, disinfection, decontamination, packaging and, where 
appropriate,  the  validated  method  of  re-sterilisation.  Information  should  be 
provided to identify when the device should no longer be reused, e.g. signs of 
material degradation or the maximum number of allowable reuses. 

If the device bears an indication that the device is for single use, information 
on known characteristics and technical factors known to the manufacturer that 
could pose a risk if the device were to be re-used. If in accordance with point c) 
of  Section  19.1  no  instructions  for  use  are  needed,  the  information  shall  be 
made available to the user upon request. 

(i) 

(j) 

(k) 

(l) 

(m)  For devices intended for use together with other devices and/or general purpose 

equipment: 

– 

– 

information  to  identify  such  devices  or  equipment,  in  order  to  obtain  a 
safe combination, and/or 

information  on  any  known  restrictions  to  combinations  of  devices  and 
equipment. 

(n) 

If  the  device  emits  hazardous,  or  potentially  hazardous  levels  of  radiation  for 
medical purposes:  

– 

detailed  information  as  to  the  nature,  type  and  where  appropriate,  the 
intensity and distribution of the emitted radiation; 

EN 

114 

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– 

the means of protecting the patient, user, or other person from unintended 
radiation during use of the device. 

(o) 

Information that allows the user and/or patient to be informed of any warnings, 
precautions, measures to be taken and limitations of use regarding the device. 
This information should cover, where appropriate: 

– 

– 

– 

– 

– 

– 

warnings,  precautions  and/or  measures  to  be  taken  in  the  event  of 
malfunction of the device or changes in its performance that may affect 
safety; 

warnings,  precautions  and/or  measures  to  be  taken  in  regards  to  the 
exposure to reasonably foreseeable external influences or environmental 
conditions, 
and 
electromagnetic effects, electrostatic discharge, radiation associated with 
diagnostic or therapeutic procedures, pressure, humidity, or temperature; 

as  magnetic 

electrical 

external 

fields, 

such 

warnings, precautions and/or measures to be taken in regards to the risks 
of  interference  posed  by  the  reasonably  foreseeable  presence  of  the 
investigations,  evaluations,  or 
device  during  specific  diagnostic 
therapeutic 
(e.g.  electromagnetic 
treatment  or  other  procedures 
interference emitted by the device affecting other equipment); 

if the device is intended to administer medicinal products, tissues or cells, 
or their derivatives, of human or animal origin or biological substances, 
any  limitations  or  incompatibility  in  the  choice  of  substances  to  be 
delivered; 

warnings,  precautions  and/or  limitations  related  to  the  medicinal 
substance or biological material that is incorporated into the device as an 
integral part of the device; 

precautions  related  to  materials  incorporated  into  the  device  that  are 
carcinogenic,  mutagenic  or  toxic,  or  that  have  endocrine  disrupting 
properties  or  that  could  result  in  sensitisation  or  allergic  reaction  of  the 
patient or user. 

(p)  Warnings  or  precautions  to be  taken in order  to facilitate  the safe disposal of 
the  device,  its  accessories  and  the  consumables  used  with  it,  if  any.  This 
information should cover, where appropriate: 

– 

infection  or  microbial  hazards  (e.g.  explants,  needles  or  surgical 
equipment contaminated with potentially infectious substances of human 
origin); 

– 

physical hazards (e.g. from sharps). 

(q)  For devices intended for use by lay persons, the circumstances when the user 

should consult with a healthcare professional. 

EN 

115 

   EN 

 
(r)  For devices listed in Annex XV for which the manufacturer does not claim a 
medical  purpose,  information  regarding  the  absence  of  a  clinical  benefit  and 
the risks related to the use of the device. 

(s)  Date of issue of the instructions for use or, if they have been revised, date of 

issue and identifier of the latest revision of the instructions for use. 

(t)  A notice to the user and/or patient that any serious incident that has occurred in 
relation to the device should be reported to the manufacturer and the competent 
authority of the Member State where the user and/or patient is established.  

EN 

116 

   EN 

 
ANNEX II  

TECHNICAL DOCUMENTATION 

The  technical  documentation  and,  if  applicable,  the  summary  technical  documentation 
(STED)  to  be  drawn  up  by  the  manufacturer  shall  include  in  particular  the  following 
elements: 

1. 

DEVICE  DESCRIPTION  AND 
ACCESSORIES  

SPECIFICATION, 

INCLUDING  VARIANTS  AND 

1.1. 

Device description and specification 

(a)  product  or  trade  name  and  a  general  description  of  the  device  including  its 

intended purpose, 

(b) 

the UDI device identifier as referred to in item (i) of point (a) of Article 24(1) 
attributed  by  the  manufacturer  to  the  device  in  question,  as  soon  as 
identification of this device shall be based on a UDI system, or otherwise clear 
identification  by  means  of  product  code,  catalogue  number  or  other 
unambiguous reference allowing traceability; 

(c) 

the intended patient population and medical condition to be diagnosed and/or 
treated and other considerations such as patient selection criteria; 

(d)  principles of operation of the device; 

(e) 

risk class and the applicable classification rule according to Annex VII; 

(f) 

an explanation of any novel features; 

(g) 

(h) 

(i) 

a description of the accessories, other medical devices and other products that 
are not medical devices, which are intended to be used in combination with it; 

a  description  or  complete  list  of  the  various  configurations/variants  of  the 
device that will be made available;  

a general description of the key functional elements, e.g. its parts/components 
(including  software  if  appropriate),  its  formulation,  its  composition,  its 
functionality.  Where  appropriate, 
labelled  pictorial 
representations  (e.g.  diagrams,  photographs,  and  drawings),  clearly  indicating 
key  parts/components,  including  sufficient  explanation  to  understand  the 
drawings and diagrams; 

this  shall 

include 

(j) 

a description of the (raw) materials incorporated into key functional elements 
and those making either direct contact with the human body or indirect contact 
with the body, e.g., during extracorporeal circulation of body fluids; 

(k) 

technical  specifications  (features,  dimensions  and  performance  attributes)  of 
the  medical  device  and  any  variants  and  accessories  that  would  typically 

EN 

117 

   EN 

 
appear  in  the  product  specification  made  available  to  the  user,  e.g.  in 
brochures, catalogues and the like. 

1.2. 

Reference to previous and similar generations of the device  

(a) 

(b) 

an overview of the manufacturer’s previous generation(s) of the device, if such 
exist;  

an  overview  of  the  manufacturer’s  similar  devices  available  on  the  EU  or 
international markets, if such exist. 

2. 

INFORMATION SUPPLIED BY THE MANUFACTURER 

(a) 

a complete set of  

– 

– 

the label(s) on the device and on its packaging; 

the instructions for use; 

(b) 

a  list  of  the  language  variants  for  the  Member  States  where  the  device  is 
envisaged to be marketed. 

3. 

DESIGN AND MANUFACTURING INFORMATION 

(a) 

Information to allow a general understanding of the design stages applied to the 
device  and  the  manufacturing  processes  such  as  production,  assembly,  final 
product  testing,  and  packaging  of  the  finished  device.  More  detailed 
information  needs  to  be  provided  for  the  audit  of  the  quality  management 
system or other applicable conformity assessment procedures;  

(b) 

identification of all sites, including suppliers and sub-contractors, where design 
and manufacturing activities are performed.  

4. 

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS  

The documentation shall contain information regarding the solutions adopted to meet 
the  general  safety  and  performance  requirements  laid  down  in  Annex  I.  This 
information may take the form of a checklist identifying  

(a) 

(b) 

the  general safety  and performance requirements that apply to the device and 
why others do not apply; 

the  method(s)  used  to  demonstrate  conformity  with  each  applicable  general 
safety and performance requirement;  

(c) 

the harmonised standards or CTS applied or other method(s) employed; 

(d) 

the  precise  identity  of  the  controlled  documents  offering  evidence  of 
conformity with each harmonised standard, CTS or other method employed to 
demonstrate conformity with the general safety and performance requirements. 

EN 

118 

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This  information  shall  incorporate  a  cross-reference  to  the  location  of  such 
evidence  within  the  full  technical  documentation  and,  if  applicable,  the 
summary technical documentation.  

5. 

RISK/BENEFIT ANALYSIS AND RISK MANAGEMENT 

The documentation shall contain a summary of  

(a) 

the risk/benefit analysis referred to in Sections 1 and 5 of Annex I, and  

(b) 

the  solutions  adopted  and  the  results  of  the  risk  management  referred  to  in 
Section 2 of Annex I. 

6. 

PRODUCT VERIFICATION AND VALIDATION 

The  documentation  shall  contain  the  results  of  verification  and  validation  testing 
and/or  studies  undertaken  to  demonstrate  conformity  of  the  device  with  the 
requirements  of  this  Regulation  and  in  particular  the  applicable  general  safety  and 
performance requirements.  

6.1. 

Pre-clinical and clinical data  

(a) 

results of (engineering, laboratory, simulated use, animal) tests and evaluation 
of published literature applicable to the device or substantially similar devices 
regarding  the  pre-clinical  safety  of  the  device  and  its  conformity  with  the 
specifications;  

(b)  detailed  information  regarding  test  design,  complete  test  or  study  protocols, 
methods  of  data  analysis,  in  addition  to  data  summaries  and  test  conclusions 
regarding  

– 

– 

– 

– 

biocompatibility  (identifying  all  materials  in  direct  or  indirect  contact 
with the patient or user); 

physical, chemical and microbiological characterisation; 

electrical safety and electromagnetic compatibility; 

software  verification  and  validation  (describing  the  software  design  and 
development  process  and  evidence  of  the  validation  of  the  software,  as 
used in the finished device. This information should typically include the 
summary results of all verification, validation and testing performed both 
in-house  and  in  a  simulated  or  actual  user  environment  prior  to  final 
release. It should also address all of the different hardware configurations 
and,  where  applicable,  operating  systems  identified  in  the  information 
supplied by the manufacturer);  

– 

stability/shelf life. 

EN 

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Where applicable, conformity with the provisions of Directive 2004/10/EC of 
the  European  Parliament  and  of  the  Council  of  11  February  2004  on  the 
harmonisation of laws, regulations and administrative provisions relating to the 
application of the principles of good laboratory practice and the verification of 
their applications for tests on chemical substances63 shall be demonstrated.  

Where  no  new  testing  has  been  undertaken,  the  documentation  shall 
incorporate  a  rationale  for  that  decision,  e.g.  biocompatibility  testing  on  the 
identical materials was conducted when these were incorporated in a previous 
version  of  the  device  that  has  been  legally  placed  on  the  market  or  put  into 
service;  

the report on the clinical evaluation in accordance with Article 49(5) and Part 
A of Annex XIII; 

the  PMCF  plan  and  PMCF  evaluation  report  in  accordance  with  Part  B  of 
Annex  XIII  or  any  justification  why  a  PMCF  is  not  deemed  necessary  or 
appropriate. 

(c) 

(d) 

6.2. 

Additional information in specific cases 

(a)  Where  a  device  incorporates,  as  an  integral  part,  a  substance  which,  if  used 
separately, may be considered to be a medicinal product within the meaning of 
Article 1 of Directive 2001/83/EC, including a medicinal product derived from 
human blood or human plasma, referred to in the first subparagraph of Article 
1(4),  a  statement  indicating  this  fact.  In  this  case,  the  documentation  shall 
identify the source of that substance and contain the data of the tests conducted 
to  assess  its  safety,  quality  and  usefulness,  taking  account  of  the  intended 
purpose of the device. 

(b)  Where  a  device  is  manufactured  utilising  tissues  or  cells  of  human  or  animal 
origin,  or  their  derivatives,  that  are covered  by  this  Regulation  in  accordance 
with point (e) of Article 1(2), a statement indicating this fact. In this case, the 
documentation shall identify all materials of human or animal origin used and 
provide detailed information concerning the conformity with Sections 10.1. or 
10.2., respectively, of Annex I.  

(c) 

In  the  case  of  devices  placed  on  the  market  in  a  sterile  or  defined 
microbiological condition a description of the environmental conditions for the 
relevant manufacturing steps. In the case of devices placed on the market in a 
sterile  condition,  a  description  of  the  methods  used,  including  the  validation 
reports,  with  respect  to  packaging,  sterilisation  and  maintenance  of  sterility. 
The  validation  report  shall  address  bioburden  testing,  pyrogen  testing  and,  if 
applicable, testing for sterilant residues.  

(d) 

In  the  case  of  devices  placed  on  the  market  with  a  measuring  function,  a 
description of the methods used in order to ensure the accuracy as given in the 
specifications. 

63 

OJ L 50, 20.2.2004, p. 44. 

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(e) 

If  the  device  is  to  be  connected  to  other  device(s)  in  order  to  operate  as 
intended, a description of this combination including proof that it conforms to 
the general safety and performance requirements when connected to any such 
device(s) having regard to the characteristics specified by the manufacturer. 

EN 

121 

   EN 

 
ANNEX III 

EU DECLARATION OF CONFORMITY 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

Name,  registered  trade  name  or  registered  trade  mark  of  the  manufacturer  and,  if 
applicable, his authorised representative, and the address of their registered place of 
business where they can be contacted and their location be established; 

A statement that the declaration of conformity is issued under the sole responsibility 
of the manufacturer; 

The  UDI  device  identifier  as  referred  to  in  item  (i)  of  point  (a)  of  Article  24(1)  as 
soon as identification of the device that is covered by the declaration shall be based 
on a UDI system;  

Product  or  trade  name,  product  code,  catalogue  number  or  other  unambiguous 
reference allowing identification and traceability of the device that is covered by the 
declaration (it may include a photograph, where appropriate). Except for the product 
or  trade  name,  the  information  allowing  identification  and  traceability  may  be 
provided by the device identifier referred to in point 3;  

Risk class of the device in accordance with Annex VII; 

A statement that the device that is covered by the present declaration is in conformity 
with  this  Regulation  and,  if  applicable,  with  other  relevant  Union  legislation  that 
make provision for the issuing of a declaration of conformity;  

References  to  the  relevant  harmonised  standards  or  CTS  used  in  relation  to  which 
conformity is declared; 

Where applicable, name and identification number of the notified body, description 
of  the  conformity  assessment  procedure  performed  and  identification  of  the 
certificate(s) issued; 

Where applicable, additional information; 

Place  and  date  of  issue,  name  and  function  of  the  person  who  signs  as  well  as 
indication for and on behalf of whom he/she signs, signature. 

EN 

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ANNEX IV 

CE MARKING OF CONFORMITY 

1. 

The CE marking shall consist of the initials ‘CE’ taking the following form:  

2. 

3. 

If  the  CE  marking  is  reduced  or  enlarged  the  proportions  given  in  the  above 
graduated drawing shall be respected. 

The various components of the CE marking shall have substantially the same vertical 
dimension,  which  may  not  be  less  than  5  mm.  This  minimum  dimension  may  be 
waived for small-scale devices. 

EN 

123 

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ANNEX V 

INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF 
DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH 
ARTICLE 25 

AND  

DATA ELEMENTS OF THE UDI DEVICE IDENTIFIER IN 
ACCORDANCE  
WITH ARTICLE 24 

PART A 
INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF DEVICES IN ACCORDANCE 
WITH ARTICLE 25  

Manufacturers  or,  when  applicable,  authorised  representatives,  and,  when  applicable, 
importers shall submit the following information: 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

economic operator's role (manufacturer, authorised representative, or importer),  

name, address and contact details of the economic operator, 

where submission of information is completed by another person on behalf of any of 
the  economic  operators  mentioned  under  point  1,  the  name,  address  and  contact 
details of this person, 

UDI device identifier, or where identification of the device is not yet based on a UDI 
system, the data elements laid down in points 5 to 21 of Part B of this Annex, 

type, number and expiry date of certificate and name or identification number of the 
notified  body  that  has  issued  the  certificate  (and  link  to  the  information  on  the 
certificate entered by the notified body in the electronic system on certificates), 

Member State where the device shall or has been placed on the market in the Union, 

in case of devices classified as classes IIa, IIb or III: Member States where the device 
is or shall be made available, 

in case of imported device: country of origin, 

risk class of the device, 

reprocessed single use device (y/n), 

presence  of  a  substance  which,  if  used  separately,  may  be  considered  to  be  a 
medicinal product and name of this substance, 

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12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

presence  of  a  substance  which,  if  used  separately,  may  be  considered  a  medicinal 
product derived from human blood or human plasma and name of this substance, 

presence of human tissues or cells, or their derivatives (y/n), 

presence of animal tissues or cells, or their derivatives, as referred to in Commission 
Regulation (EU) No 722/2012 (y/n), 

where  applicable,  single  identification  number  of  the  clinical  investigation(s) 
conducted in relation to the device (or link to the clinical investigation registration in 
the electronic system regarding clinical investigations), 

in case of devices listed in Annex XV, specification whether the intended purpose of 
the device is other than a medical purpose,  

in case of devices designed and manufactured by another legal or natural person as 
referred in Article 8(10), the name, address and contact details of that legal or natural 
person,  

in  case  of  devices  classified  as  class  III  or  implantable  devices,  the  summary  of 
safety and clinical performance, 

status  of  the  device  (on  the  market,  no  longer  manufactured,  withdrawn  from  the 
market, recalled). 

PART B 
DATA ELEMENTS OF THE UDI DEVICE IDENTIFIER IN ACCORDANCE WITH ARTICLE 24 

The  UDI  device  identifier  shall  provide  access  to  the  following  information  related  to  the 
manufacturer and the device model: 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

quantity per package configuration, 

if applicable, alternative or additional identifier(s), 

the way how the device production is controlled (expiration date or manufacturing date, 
lot or batch number, serialisation number), 

if applicable, the unit of use device identifier (when a UDI is not assigned to the device 
at the level of its unit of use, a 'unit of use' device identifier shall be assigned to associate 
the use of a device with a patient), 

name and address of the manufacturer (as indicated on the label), 

if applicable, name and address of the authorised representative (as indicated on the 
label), 

Global  Medical  Device  Nomenclature  (GMDN)  code  or  internationally  recognised 
nomenclature code, 

if applicable, trade/brand name, 

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9. 

10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

18. 

19. 

20. 

21. 

if applicable, device model, reference, or catalogue number, 

if applicable, clinical size (including volume, length, gauge, diameter), 

additional product description (optional), 

if applicable, storage and/or handling conditions (as indicated on the label or in the 
instructions for use), 

if applicable, additional trade names of the device,  

labelled as single use device (y/n), 

if applicable, restricted number of reuses, 

device packaged sterile (y/n), 

need for sterilisation before use (y/n), 

labelled as containing latex (y/n), 

labelled as containing DEHP (y/n), 

URL for additional information, e.g. electronic instructions for use (optional), 

if applicable, critical warnings or contraindications. 

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MINIMUM REQUIREMENTS TO BE MET BY NOTIFIED BODIES 

ANNEX VI  

1. 

ORGANISATIONAL AND GENERAL REQUIREMENTS 

1.1. 

Legal status and organisational structure  

1.1.1.  A  notified  body  shall  be  established  under  the  national  law  of  a  Member  State,  or 
under the law of a third country with which the Union has concluded an agreement in 
this respect, and shall have full documentation of its legal personality and status. This 
shall include information about ownership and the legal or natural persons exercising 
control over the notified body.  

1.1.2. 

1.1.3. 

If the notified body is a legal entity that is part of a larger organisation, the activities 
of  this  organisation  as  well  as  its  organisational  structure  and  governance,  and  the 
relationship with the notified body shall be clearly documented. 

If  the  notified  body  wholly  or  partly  owns  legal  entities  established  in  a  Member 
State or in a third country, the activities and responsibilities of those entities, as well 
as  their  legal  and  operational  relationships  with  the  notified  body,  shall  be  clearly 
defined and documented. 

1.1.4.  The  organisational  structure,  distribution  of  responsibilities  and  operation  of  the 
notified body shall be such that it assures confidence in the performance and results 
of the conformity assessment activities conducted.  

The  organisational  structure  and  the  functions,  responsibilities  and  authority  of  its 
top-level  management  and  of  other  personnel  with  influence  upon  the  performance 
and results of the conformity assessment activities shall be clearly documented. 

1.2. 

Independence and impartiality 

1.2.1.  The notified body shall be a third-party body that is independent of the manufacturer 
of the product in relation to which it performs conformity assessment activities. The 
notified  body  shall  also  be  independent  of  any  other  economic  operator  having  an 
interest in the product as well as of any competitor of the manufacturer.  

1.2.2.  The  notified  body  shall  be  organised  and  operated  so  as  to  safeguard  the 
independence,  objectivity  and  impartiality  of  its  activities.  The  notified  body  shall 
have  procedures  in  place  that  effectively  ensure  identification,  investigation  and 
resolution  of  any  case  in  which  a  conflict  of  interests  may  arise,  including 
involvement in consultancy services in the field of medical devices prior to taking up 
employment with the notified body. 

1.2.3.  The  notified  body,  its  top-level  management  and  the  personnel  responsible  for 

carrying out the conformity assessment tasks shall not  

– 

be  the  designer,  manufacturer,  supplier,  installer,  purchaser,  owner,  user  or 
maintainer  of  the  products,  nor  the  authorised  representative  of  any  of  those 

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parties. This shall not preclude the purchase and use of assessed products that 
are  necessary  for  the  operations  of  the  notified  body  (e.g.  measuring 
equipment),  the  conduct  of  the  conformity  assessment  or  the  use  of  such 
products for personal purposes; 

– 

– 

be directly involved in the design, manufacture or construction, the marketing, 
installation, use or maintenance of the products which they assess, or represent 
the  parties  engaged  in  those  activities.  They  shall  not  engage  in  any  activity 
that may conflict with their independence of judgement or integrity in relation 
to conformity assessment activities for which they are notified;  

offer  or  provide  any  service  which  may  jeopardise  the  confidence  in  their 
independence,  impartiality  or  objectivity.  In  particular,  they shall  not  offer  or 
provide consultancy services to the manufacturer, his authorised representative, 
a  supplier  or  a  commercial  competitor  as  regards  the  design,  construction, 
marketing or maintenance of the products or processes under assessment. This 
does  not  preclude  general  training  activities  relating  to  medical  device 
regulations or related standards that are not client specific. 

1.2.4.  The  impartiality  of  the  notified  bodies,  of  their  top  level  management  and  of  the 
assessment  personnel  shall  be  guaranteed.  The  remuneration  of  the  top  level 
management  and  assessment  personnel  of  a  notified  body  shall  not  depend  on  the 
results of the assessments. 

1.2.5. 

If  a  notified  body  is  owned  by  a  public  entity  or  institution,  independence  and 
absence of any conflict of interests must be ensured and documented between, on the 
one  hand,  the  national  authority  responsible  for  notified  bodies  and/or  competent 
authority and, on the other hand, the notified body.  

1.2.6.  The notified body shall ensure and document that the activities of its subsidiaries or 
subcontractors, or of any associated body, do not affect its independence, impartiality 
or objectivity of its conformity assessment activities.  

1.2.7.  The  notified  body  shall  operate  in  accordance  with  a  set  of  consistent,  fair  and 
reasonable  terms  and  conditions,  taking  into  account  the  interests  of  small  and 
medium-sized 
as  defined  by  Commission  Recommendation 
2003/361/EC. 

enterprises 

1.2.8.  The  requirements  of  this  section  in  no  way  preclude  exchanges  of  technical 
information  and  regulatory  guidance  between  a  notified  body  and  a  manufacturer 
seeking their conformity assessment. 

1.3. 

Confidentiality  

The personnel of a notified body shall observe professional secrecy with regard to all 
information  obtained  in  carrying  out  their  tasks  under  this  Regulation,  except  in 
relation  to  the  national  authorities  responsible  for  notified  bodies,  competent 
authorities or the Commission. Proprietary rights shall be protected. To this end, the 
notified body shall have documented procedures in place. 

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1.4. 

Liability 

The  notified  body  shall  take  out  appropriate  liability  insurance  that  corresponds  to 
the  conformity  assessment  activities  for  which  it  is  notified,  including  the  possible 
suspension, restriction or withdrawal of certificates, and the geographic scope of its 
activities, unless liability is assumed by the State in accordance with national law, or 
the Member State itself is directly responsible for the conformity assessment.  

1.5. 

Financial requirements 

The  notified  body  shall  have  at  its  disposal  the  financial  resources  required  to 
conduct its conformity assessment activities and related business operations. It shall 
document and provide evidence of its financial capacity and its sustainable economic 
viability, taking into account specific circumstances during an initial start-up phase. 

1.6. 

Participation in coordination activities 

1.6.1.  The  notified  body  shall  participate  in,  or  ensure  that  its  assessment  personnel  is 
informed  of  the  relevant  standardisation  activities  and  the  activities  of  the  notified 
body coordination group and that its assessment and decision making personnel are 
informed of all relevant legislation, guidance and best practice documents adopted in 
the framework of this Regulation.  

1.6.2.  The notified body shall adhere to a code of conduct, addressing among other things, 
ethical  business  practices  for  notified  bodies  in  the  field  of  medical  devices  that  is 
accepted  by  the  national  authorities  responsible  for  notified  bodies.  The  code  of 
conduct  shall  provide  for  a  mechanism  of  monitoring  and  verification  of  its 
implementation by notified bodies. 

2. 

QUALITY MANAGEMENT REQUIREMENTS 

2.1. 

The  notified  body  shall  establish,  document,  implement,  maintain  and  operate  a 
quality  management  system  that  is  appropriate  to  the  nature,  area  and  scale  of  its 
conformity  assessment  activities  and  capable  of  supporting  and  demonstrating  the 
consistent achievement of the requirements of this Regulation.  

2.2. 

The  quality  management  system  of  the  notified  body  shall  at  least  address  the 
following: 

– 

– 

– 

– 

– 

– 

policies for assignment of personnel to activities and their responsibilities; 

decision-making process in accordance with the tasks, responsibilities and role 
of the top-level management and other notified body personnel; 

control of documents;  

control of records;  

management review;  

internal audits;  

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– 

– 

corrective and preventive actions;  

complaints and appeals. 

3. 

RESOURCE REQUIREMENTS 

3.1. 

General 

3.1.1.  A  notified  body  shall  be  capable  of  carrying  out  all  the  tasks  assigned  to  it  by  this 
Regulation  with  the  highest  degree  of  professional  integrity  and  the  requisite 
technical competence in the specific field, whether those tasks are carried out by the 
notified body itself or on its behalf and under its responsibility.  

In particular, it shall have the necessary personnel and shall possess or have access to 
all  equipment  and  facilities  needed  to  perform  properly  the  technical  and 
administrative  tasks  entailed  in  the  conformity  assessment  activities  in  relation  to 
which it has been notified.  

This  presupposes  the  availability  within  its  organisation  of  sufficient  scientific 
personnel  who  possess  experience  and  knowledge  sufficient  to  assess  the  medical 
functionality  and  performance  of  devices  for  which  it  has  been  notified,  having 
regard  to  the  requirements  of  this  Regulation  and,  in  particular,  those  set  out  in 
Annex I. 

3.1.2.  At all times and for each conformity assessment procedure and each kind or category 
of products in relation to which it has been notified, a notified body shall have within 
its organisation the necessary administrative, technical and scientific personnel with 
technical  knowledge  and  sufficient  and  appropriate  experience  relating  to  medical 
devices  and  the  corresponding  technologies  to  perform  the  conformity  assessment 
tasks, including the assessment of clinical data. 

3.1.3.  The  notified  body  shall  clearly  document  the  extent  and  the  limits  of  the  duties, 
responsibilities  and  authorities  in  relation  of  the  personnel  involved  in  conformity 
assessment activities and inform the personnel concerned about it.  

3.2. 

Qualification criteria in relation to personnel  

3.2.1.  The Notified Body shall establish and document qualification criteria and procedures 
for  selection  and  authorisation  of  persons  involved  in  conformity  assessment 
activities  (knowledge,  experience  and  other  competence  required)  and  the  required 
training  (initial  and  ongoing  training).  The  qualification  criteria  shall  address  the 
various  functions  within  the  conformity  assessment  process  (e.g.  auditing,  product 
evaluation/testing,  design  dossier/file  review,  decision-making)  as  well  as  the 
devices, technologies and areas (e.g. biocompatibility, sterilisation, tissues and cells 
of human and animal origin, clinical evaluation) covered by the scope of designation. 

3.2.2.  The qualification criteria shall refer to the scope of the notified body's designation in 
accordance with the scope description used by the Member State for the notification 
referred  to  in  Article  33,  providing  sufficient  level  of  detail  for  the  required 
qualification within the subdivisions of the scope description.  

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Specific qualification criteria shall be defined for the assessment of biocompatibility 
aspects, clinical evaluation and the different types of sterilisation processes. 

3.2.3.  The  personnel  responsible  for  authorising  other  personnel  to  perform  specific 
conformity assessment activities and the personnel with overall responsibility for the 
final review and decision-making on certification shall be employed by the notified 
body  itself  and  shall  not  be  subcontracted.  These  personnel  altogether  shall  have 
proven knowledge and experience in the following: 

– 

– 

– 

– 

– 

– 

– 

Union medical devices legislation and relevant guidance documents; 

the conformity assessment procedures in accordance with this Regulation; 

a broad base of medical device technologies, the medical device industry and 
the design and manufacture of medical devices; 

the notified body’s quality management system and related procedures; 

the  types  of  qualifications  (knowledge,  experience  and  other  competence) 
required for carrying out conformity assessments in relation to medical devices 
as well as the relevant qualification criteria; 

training  relevant  to  personnel  involved  in  conformity  assessment  activities  in 
relation to medical devices; 

the  ability  to  draw  up  certificates,  records  and  reports  demonstrating  that  the 
conformity assessments have been appropriately carried out. 

3.2.4.  Notified bodies shall have available personnel with clinical expertise. This personnel 
shall be integrated in the notified body's decision-making process in a steady way in 
order to: 

– 

– 

– 

– 

– 

identify  when  specialist  input  is  required  for  the  assessment  of  the  clinical 
evaluation conducted by the manufacturer and identify appropriately qualified 
experts; 

appropriately train external clinical experts in the relevant requirements of this 
Regulation,  delegated  and/or  implementing  acts,  harmonised  standards,  CTS 
and guidance documents and ensure that the external clinical experts are fully 
aware of the context and implication of their assessment and advice provided; 

be able to discuss the clinical data contained within the manufacturer's clinical 
evaluation  with  the  manufacturer  and  with  external  clinical  experts  and  to 
appropriately  guide  external  clinical  experts  in  the  assessment  of  the  clinical 
evaluation; 

be able to scientifically challenge the clinical data presented, and the results of 
the  external  clinical  experts'  assessment  of  the  manufacturer's  clinical 
evaluation; 

be  able  to  ascertain  the  comparability  and  consistency  of  the  clinical 
assessments conducted by clinical experts; 

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– 

be  able  to  make  an  objective  clinical  judgement  about  the  assessment  of  the 
manufacturer's clinical evaluation and make a recommendation to the notified 
body's decision maker. 

3.2.5.  The personnel responsible for carrying out product related review (e.g. design dossier 
review, technical documentation review or type examination including aspects such 
as clinical evaluation, biological safety, sterilisation, software validation) shall have 
the following proven qualification: 

– 

– 

– 

– 

– 

successful  completion  of  a  university  or  a  technical  college  degree  or 
equivalent  qualification  in  relevant  studies,  e.g.  medicine,  natural  science  or 
engineering;  

four years professional experience in the field of healthcare products or related 
sectors (e.g. industry, audit, healthcare, research  experience) whilst  two years 
of  this  experience  shall  be  in  the  design,  manufacture,  testing  or  use  of  the 
device  or  technology  to  be  assessed  or  related  to  the  scientific  aspects  to  be 
assessed; 

appropriate knowledge of the general safety and performance requirements laid 
down  in  Annex  I  as  well  as  related  delegated  and/or  implementing  acts, 
harmonised standards, CTS and guidance documents; 

appropriate knowledge and experience of risk management and related medical 
device standards and guidance documents; 

appropriate  knowledge  and  experience  of 
the  conformity  assessment 
procedures laid down in Annexes VIII to X, in particular of those aspects for 
which  they  are  authorised,  and  adequate  authority  to  carry  out  those 
assessments. 

3.2.6.  The  personnel  responsible  for  carrying  out  audits  of  the  manufacturer's  quality 

management system shall have the following proven qualification: 

– 

– 

– 

– 

– 

successful  completion  of  a  university  or  a  technical  college  degree  or 
equivalent  qualification  in  relevant  studies,  e.g.  medicine,  natural  science  or 
engineering; 

four years professional experience in the field of healthcare products or related 
sectors (e.g. industry, audit, healthcare, research  experience) whilst  two years 
of this experience shall be in the area of quality management; 

appropriate  knowledge  of  the  medical  devices  legislation  as  well  as  related 
delegated and/or implementing acts, harmonised standards, CTS and guidance 
documents; 

appropriate knowledge and experience of risk management and related medical 
device standards and guidance documents; 

appropriate  knowledge  of  quality  management  systems  and  related  standards 
and guidance documents  

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– 

– 

appropriate  knowledge  and  experience  of 
the  conformity  assessment 
procedures laid down in Annexes VIII to X, in particular of those aspects for 
which they are authorised, and adequate authority to carry out the audits; 

training in auditing techniques enabling them to challenge quality management 
systems. 

3.3. 

Documentation of qualification, training and authorisation of personnel  

3.3.1.  The notified body shall have a process in place to fully document the qualification of 
each  personnel  involved  in  conformity  assessment  activities  and  the  satisfaction  of 
the  qualification  criteria  referred  to  in  Section  3.2.  Where  in  exceptional 
circumstances the fulfilment of the qualification criteria set out in Section 3.2 cannot 
be fully demonstrated, the notified body shall appropriately justify the authorisation 
of these personnel to carry out specific conformity assessment activities.  

3.3.2.  For  its  personnel  referred  to  in  Sections  3.2.3  to  3.2.6,  the  notified  body  shall 

establish and maintain up to date: 

– 

– 

a  matrix  detailing  the  responsibilities  of  the  personnel  in  respect  of  the 
conformity assessment activities; 

records  demonstrating  the  required  knowledge  and  experience  for  the 
conformity assessment activity for which they are authorised. 

3.4. 

Subcontractors and external experts  

3.4.1.  Without  prejudice  to  the  limitations  emanating  from  Section  3.2.,  notified  bodies 
may  subcontract  clearly  defined  parts  of  the  conformity  assessment  activities.  The 
subcontracting of the auditing of quality management systems or of product related 
reviews as a whole is not allowed. 

3.4.2.  Where  a  notified  body  subcontracts  conformity  assessment  activities  either  to  an 
organisation or an individual, it shall have a policy describing the conditions under 
which subcontracting may take place. Any subcontracting or consultation of external 
experts shall be properly documented and be subject to a written agreement covering, 
among others, confidentiality and conflict of interests. 

3.4.3.  Where  subcontractors  or  external  experts  are  used  in  the  context  of  the  conformity 
assessment, in particular regarding novel, invasive and implantable medical devices 
or  technologies,  the  notified  body  shall  have  adequate  own  competence  in  each 
product area for which it is designated to lead the conformity assessment, to verify 
the  appropriateness  and  validity  of  expert  opinions  and  make  the  decision  on  the 
certification. 

3.4.4.  The  notified  body  shall  establish  procedures  for  assessing  and  monitoring  the 

competence of all subcontractors and external experts used. 

3.5.  Monitoring of competences and training  

3.5.1.  The  notified  body  shall  appropriately  monitor  the  satisfactory  performance  of  the 

conformity assessment activities by its personnel.  

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3.5.2. 

It shall review the competence of its personnel and identify training needs in order to 
maintain the required level of qualification and knowledge.  

4. 

PROCESS REQUIREMENTS  

4.1. 

4.2. 

The notified body's decision-making process shall be clearly documented, including 
the  process  for  the  issue,  suspension,  reinstatement,  withdrawal  or  refusal  of 
conformity assessment certificates, their modification or restriction and the issue of 
supplements. 

The  notified  body  shall  have  in  place  a  documented  process  for  the  conduct  of  the 
conformity assessment procedures for which it is designated taking into account their 
respective  specificities,  including  legally  required  consultations,  in  respect  of  the 
different  categories  of  devices  covered  by  the  scope  of  notification,  ensuring 
transparency and the ability of reproduction of those procedures. 

4.3. 

The notified body shall have in place documented procedures covering at least:  

– 

– 

– 

– 

– 

– 

– 

– 

the  application  for  conformity  assessment  by  a  manufacturer  or  by  an 
authorised representative, 

the processing of the application, including the verification of the completeness 
of  the  documentation,  the  qualification  of  the  product  as  device  and  its 
classification, 

language  of 

the 
documentation to be submitted,  

the  application,  of 

the  correspondence  and  of 

the 

the terms of the agreement with the manufacturer or authorised representative, 

the fees to be charged for conformity assessment activities,  

the assessment of relevant changes to be submitted for prior approval,  

the planning of surveillance,  

the renewal of certificates.  

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ANNEX VII 

CLASSIFICATION CRITERIA 

I. SPECIFIC DEFINITIONS FOR THE CLASSIFICATION RULES  

1. 

DURATION OF USE  

1.1. 

1.2. 

‘Transient’ means normally intended for continuous use for less than 60 minutes. 

‘Short  term’  means  normally  intended  for  continuous  use  for  between  60  minutes 
and 30 days. 

1.3. 

‘Long term’ means normally intended for continuous use for more than 30 days. 

2. 

INVASIVE AND ACTIVE DEVICES 

2.1. 

‘Body orifice’ means any natural opening in the body, as well as the external surface 
of  the  eyeball,  or  any  permanent  artificial  opening,  such  as  a  stoma  or  permanent 
tracheotomy. 

2.2. 

‘Surgically invasive device’ means  

(a) 

an invasive device which penetrates inside the body through the surface of the 
body, with the aid or in the context of a surgical operation; 

(b) 

a device which produces penetration other than through a body orifice. 

2.3. 

2.4. 

2.5. 

2.6. 

‘Reusable  surgical  instrument’  means  an  instrument  intended  for  surgical  use  by 
cutting,  drilling,  sawing,  scratching,  scraping,  clamping,  retracting,  clipping  or 
similar  procedures,  without  connection  to  any  active  medical  device  and  which  are 
intended by the manufacturer to be reused after appropriate procedures for cleaning 
and/or sterilization have been carried out. 

‘Active therapeutic device’ means any active medical device, whether used alone or 
in  combination  with  other  medical  devices,  to  support,  modify,  replace  or  restore 
biological functions or structures with a view to treatment or alleviation of an illness, 
injury or disability. 

‘Active  device  intended  for  diagnosis’  means  any  active  medical  device,  whether 
used alone or in combination with other medical devices, to supply information for 
detecting,  diagnosing,  monitoring  or  treating  physiological  conditions,  states  of 
health, illnesses or congenital deformities. 

‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, 
aorta  ascendens,  arcus  aorta,  aorta  descendens  to  the  bifurcatio  aortae,  arteriae 
coronariae,  arteria  carotis  communis,  arteria  carotis  externa,  arteria  carotis  interna, 

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arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena 
cava superior, vena cava inferior. 

2.7. 

‘Central nervous system’ means the brain, meninges and spinal cord. 

II. Implementing rules for the classification rules  

1. 

2. 

3. 

4. 

5. 

Application of the classification rules shall be governed by the intended purpose of 
the devices. 

If  the  device  is  intended  to  be  used  in  combination  with  another  device,  the 
classification  rules  shall  apply  separately  to  each  of  the  devices.  Accessories  are 
classified in their own right separately from the device with which they are used. 

Stand alone software, which drives a device or influences the use of a device, falls 
automatically in the same class as the device. If stand alone software is independent 
of any other device, it is classified in its own right.  

If the device is not intended to be used solely or principally in a specific part of the 
body, it shall be considered and classified on the basis of the most critical specified 
use. 

If several rules, or within the same rule several sub-rules, apply to the same device 
based on the device’s intended purpose, the strictest rule and/or sub-rule resulting in 
the higher classification shall apply. 

6. 

In calculating the duration referred to in Chapter I, Section 1 continuous use means:  

(a)  The  entire  duration  of  use  of  the  same  device  without  regard  to  temporary 
interruption of use during a procedure or temporary removal for purposes such 
as cleaning or disinfection of the device. Whether the interruption of use or the 
removal is temporary shall be established in relation to the duration of the use 
prior and after the period when the use is interrupted or the device removed.  

(b)  The  accumulated  use  of  a  device  that  is  intended  by  the  manufacturer  to  be 

replaced immediately with another of the same type. 

7. 

A device is considered to allow direct diagnosis when it provides the diagnosis of the 
disease  or  condition  by  itself  or  when  it  provides  decisive  information  for  the 
diagnosis.  

III. Classification rules  

3. 

NON-INVASIVE DEVICES 

3.1. 

Rule 1 

All  non-invasive  devices  are  in  class  I,  unless  one  of  the  rules  set  out  hereinafter 
applies. 

EN 

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3.2. 

Rule 2 

All non-invasive  devices intended  for channelling  or storing blood,  body liquids or 
tissues,  liquids  or  gases  for  the  purpose  of  eventual  infusion,  administration  or 
introduction into the body are in class IIa: 

– 

– 

if  they  may  be  connected  to  an  active  medical  device  in  class  IIa  or  a  higher 
class, 

if  they  are  intended  for  use  for  storing  or  channelling  blood  or  other  body 
liquids or for storing organs, parts of organs or body tissues. 

In all other cases they are in class I. 

3.3. 

Rule 3 

All  non-invasive  devices  intended  for  modifying  the  biological  or  chemical 
composition  of  human  tissues  or  cells,  blood,  other  body  liquids  or  other  liquids 
intended  for  implantation  or  infusion  into  the  body  are  in  class  IIb,  unless  the 
treatment  consists  of  filtration,  centrifugation  or  exchanges  of  gas,  heat,  in  which 
case they are in class IIa. 

All  non-invasive  devices  intended  to  be  used  for  in  vitro  fertilisation  (IVF)  or 
assisted reproduction technologies (ART) which are liable to act with close contact 
on the inner or outer cells during the IVF/ART, such as washing, separating, sperm 
immobilising, cryoprotecting solutions, are in class IIb.  

3.4. 

Rule 4 

All non-invasive devices which come into contact with injured skin: 

– 

– 

– 

are  in  class  I  if  they  are  intended  to  be  used  as  a  mechanical  barrier,  for 
compression or for absorption of exudates, 

are in class IIb if they are intended to be used principally with wounds which 
have breached the dermis and can only heal by secondary intent, 

are  in  class  IIa  in  all  other  cases,  including  devices  principally  intended  to 
manage the micro-environment of a wound. 

4. 

INVASIVE DEVICES 

4.1. 

Rule 5 

All  invasive  devices  with  respect  to  body  orifices,  other  than  surgically  invasive 
devices  and  which  are  not  intended  for  connection  to  an  active  medical  device  or 
which are intended for connection to an active medical device classified as class I: 

– 

are in class I if they are intended for transient use, 

EN 

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– 

– 

are in class IIa if they are intended for short-term use, except if they are used in 
the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a 
nasal cavity, in which case they are in class I, 

are in class IIb if they are intended for long-term use, except if they are used in 
the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a 
nasal  cavity  and  are  not  liable  to  be  absorbed  by  the  mucous  membrane,  in 
which case they are in class IIa. 

All  invasive  devices  with  respect  to  body  orifices,  other  than  surgically  invasive 
devices, intended for connection to an active medical device in class IIa or a higher 
class, are in class IIa. 

4.2. 

Rule 6 

All surgically invasive devices intended for transient use are in class IIa unless they: 

– 

– 

– 

– 

– 

– 

are intended to control, diagnose, monitor or correct a defect of the heart or of 
the  central  circulatory  system  through  direct  contact  with  these  parts  of  the 
body, in which case they are in class III, 

are reusable surgical instruments, in which case they are in class I, 

are  intended  specifically  for  use  in  direct  contact  with  the  central  nervous 
system, in which case they are in class III, 

are intended to  supply energy in the form of ionising radiation in which  case 
they are in class IIb, 

have a biological effect or are wholly or  mainly  absorbed  in  which  case  they 
are in class IIb, 

are intended to administer medicines by means of a delivery system, if this is 
done in a manner that is potentially hazardous taking account of the mode of 
application, in which case they are in class IIb. 

4.3. 

Rule 7 

All  surgically  invasive  devices  intended  for  short-term  use  are  in  class  IIa  unless 
they: 

– 

– 

– 

are intended specifically to control, diagnose, monitor or correct a defect of the 
heart or of the central circulatory system through direct contact with these parts 
of the body, in which case they are in class III, 

are  intended  specifically  for  use  in  direct  contact  with  the  central  nervous 
system, in which case they are in class III, 

are intended to supply energy in the form of ionizing radiation in which case 
they are in class IIb, 

EN 

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– 

– 

have a biological effect or are wholly or  mainly  absorbed  in  which  case  they 
are in class III, 

are intended to undergo chemical change in the body, except if the devices are 
placed in the teeth, or to administer medicines, in which case they are in class 
IIb. 

4.4. 

Rule 8 

All  implantable  devices  and  long-term  surgically  invasive  devices  are  in  class  IIb 
unless they: 

– 

– 

– 

– 

– 

– 

– 

– 

are intended to be placed in the teeth, in which case they are in class IIa, 

are intended to be used in direct contact with the heart, the central circulatory 
system or the central nervous system, in which case they are in class III, 

have a biological effect or are wholly or mainly absorbed, in which case they 
are in class III, 

are intended to undergo chemical change in the body, except if the devices are 
placed in the teeth, or to administer medicines, in which case they are in class 
III, 

are  active  implantable  medical  devices  or  implantable  accessories  to  active 
implantable medical devices, in which case they are in class III, 

are breast implants, in which case they are in class III, 

are  hip,  knee  or  shoulder  total  and  partial  joint  replacements,  in  which  case 
they are in class III, with the exception of ancillary components such as screws, 
wedges, plates and instruments,  

are  spinal  disc  replacement  implants  and  implantable  devices  that  come  into 
contact with the spinal column, in which case they are in class III.  

5. 

ACTIVE DEVICES 

5.1. 

Rule 9 

All active therapeutic devices intended to administer or exchange energy are in class 
IIa unless their characteristics are such that they may administer or exchange energy 
to  or  from  the  human  body  in  a  potentially  hazardous  way,  taking  account  of  the 
nature,  the  density  and  site  of  application  of  the  energy,  in  which  case  they  are  in 
class IIb. 

All  active  devices  intended  to  control  or  monitor  the  performance  of  active 
therapeutic devices in class IIb, or intended directly to influence the performance of 
such devices are in class IIb. 

EN 

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All  active  devices  that  are  intended  for  controlling,  monitoring  or  directly 
influencing the performance of active implantable medical devices are in class III.  

5.2. 

Rule 10 

Active devices intended for diagnosis are in class IIa: 

– 

– 

– 

if  they  are  intended  to  supply  energy  which  will  be  absorbed  by  the  human 
body,  except  for  devices  used  to  illuminate  the  patient's  body,  in  the  visible 
spectrum, 

if they are intended to image in vivo distribution of radiopharmaceuticals, 

if  they  are  intended  to  allow  direct  diagnosis  or  monitoring  of  vital 
physiological processes, unless they are specifically intended for monitoring of 
vital  physiological  parameters,  where  the  nature  of  variations  is  such  that  it 
could  result  in  immediate  danger  to  the  patient,  for  instance  variations  in 
cardiac  performance,  respiration,  activity  of  central  nervous  system  in  which 
case they are in class IIb. 

Active  devices  intended  to  emit  ionizing  radiation  and  intended  for  diagnostic  or 
therapeutic interventional radiology including devices which control or monitor such 
devices, or which directly influence their performance, are in class IIb. 

5.3. 

Rule 11 

All active devices intended to administer and/or remove medicines, body liquids or 
other substances to or from the body are in class IIa, unless this is done in a manner 
that is potentially hazardous, taking account of the nature of the substances involved, 
of the part of the body concerned and of the mode of application in which case they 
are in class IIb. 

5.4. 

Rule 12 

All other active devices are in class I. 

6. 

SPECIAL RULES 

6.1. 

Rule 13 

All devices incorporating, as an integral part, a substance which, if used separately, 
can  be  considered  to  be  a  medicinal  product,  as  defined  in  Article  1  of  Directive 
2001/83/EC,  including  a  medicinal  product  derived  from  human  blood  or  human 
plasma, with action ancillary to that of the devices, are in class III. 

6.2. 

Rule 14 

All devices used for contraception or the prevention of the transmission of sexually 
transmitted  diseases  are  in  class  IIb,  unless  they  are  implantable  or  long  term 
invasive devices, in which case they are in class III. 

EN 

140 

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6.3. 

Rule 15 

All  devices  intended  specifically  to  be  used  for  disinfecting,  cleaning,  rinsing  or, 
when appropriate, hydrating contact lenses are in class IIb. 

All  devices  intended  specifically  to  be  used  for  disinfecting  or  sterilising  medical 
devices are in class IIa, unless they are disinfecting solutions or washer-disinfectors 
intended specifically to be used for disinfecting invasive devices, as the end point of 
processing, in which case they are in class IIb.  

This rule does not apply to devices that are intended to clean medical devices other 
than contact lenses by means of physical action only. 

6.4. 

Rule 16 

Devices specifically intended for recording of diagnostic images generated by X-ray, 
MRI, ultra-sound or other diagnostic devices are in class IIa.  

6.5. 

Rule 17 

All devices manufactured utilising tissues or cells of human or animal origin, or their 
derivatives, which are non-viable or rendered non-viable are in class III, unless such 
devices  are  manufactured  utilising  tissues  or  cells  of  animal  origin,  or  their 
derivatives,  which  are  non-viable  or  rendered  non-viable  that  are  intended  to  come 
into contact with intact skin only. 

6.6. 

Rule 18 

By derogation from other rules, blood bags are in class IIb. 

6.7. 

Rule 19 

All  devices  incorporating  or  consisting  of  nanomaterial  are  in  class  III  unless  the 
nanomaterial  is  encapsulated  or  bound  in  such  a  manner  that  it  cannot  be  released 
into the patient’s or user's body when the device is used within its intended purpose.  

6.8. 

Rule 20 

All  devices  intended  to  be  used  for  aphaeresis,  such  as  aphaeresis  machines,  sets, 
connectors and solutions, are in class III. 

6.9. 

Rule 21 

Devices that are composed of substances or combination of substances intended to be 
ingested,  inhaled  or  administered  rectally  or  vaginally  and  that  are  absorbed  by  or 
dispersed in the human body are in class III. 

EN 

141 

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ANNEX VIII 

CONFORMITY ASSESSMENT BASED ON FULL QUALITY ASSURANCE AND DESIGN 
EXAMINATION 

Chapter I: Full Quality Assurance System 

1. 

2. 

The  manufacturer  shall  ensure  application  of  the  quality  management  system 
approved for the design, manufacture and final inspection of the products concerned, 
as specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 3.4 
and to the surveillance as specified in Section 4. 

The manufacturer who fulfils the obligations imposed by Section 1 shall draw up and 
keep an EU declaration of conformity in accordance with Article 17 and Annex III 
for the device model covered by the conformity assessment procedure. By issuing a 
declaration  of  conformity  the  manufacturer  ensures  and  declares  that  the  devices 
concerned meet the provisions of this Regulation which apply to them.  

3. 

Quality management system 

3.1. 

The  manufacturer  shall  lodge  an  application  for  assessment  of  his  quality 
management system with a notified body. The application shall include: 

– 

– 

– 

– 

– 

– 

– 

the  name  and  address  of  the  manufacturer  and  any  additional  manufacturing 
site  covered  by  the  quality  management  system,  and,  if  the  application  is 
lodged by the authorised representative, his name and address as well, 

all  the  relevant  information  on  the  device  or  device  category  covered  by  the 
procedure, 

a  written  declaration  that  no  application  has  been  lodged  with  any  other 
notified  body  for  the  same  device-related  quality  management  system,  or 
information about any previous application for the same device-related quality 
management system that has been refused by another notified body, 

the documentation on the quality management system, 

a description of the procedures in place to fulfil the obligations imposed by the 
quality management system approved and the undertaking by the manufacturer 
to apply these procedures, 

a  description  of  the  procedures  in  place  to  keep  the  approved  quality 
management  system  adequate  and  efficacious  and  the  undertaking  by  the 
manufacturer to apply these procedures, 

the  documentation  on  the  post-market  surveillance  plan,  including,  when 
applicable,  a  plan  for  the  post-market  clinical  follow-up,  and  the  procedures 
put  in  place  to  ensure  compliance  with  the  obligations  emanating  from  the 
provisions on vigilance set out in Articles 61 to 66, 

EN 

142 

   EN 

 
– 

a  description  of  the  procedures  in  place  to  keep  up  to  date  the  post-market 
surveillance  plan,  including,  when  applicable,  a  plan  for  the  post-market 
clinical  follow-up,  and 
the 
obligations emanating from the provisions on vigilance set out in Articles 61 to 
66 as well as the undertaking by the manufacturer to apply these procedures. 

the  procedures  ensuring  compliance  with 

3.2. 

Application of the quality management system shall ensure that the devices conform 
to the provisions of this Regulation which apply to them at every stage, from design 
to  final  inspection.  All  the  elements,  requirements  and  provisions  adopted  by  the 
manufacturer for his quality management system shall be documented in a systematic 
and  orderly  manner  in  the  form  of  written  policies  and  procedures  such  as  quality 
programmes, quality plans, quality manuals and quality records. 

Moreover,  the  documentation  to  be  submitted  for  the  assessment  of  the  quality 
management system shall include an adequate description of, in particular: 

(a) 

the manufacturer’s quality objectives; 

(b) 

the organisation of the business and in particular: 

– 

– 

– 

– 

the  organisational  structures,  the  responsibilities  of  the  managerial  staff 
and 
their  organisational  authority  where  quality  of  design  and 
manufacture of the products is concerned, 

the  methods  of  monitoring  the  efficient  operation  of  the  quality 
management  system  and  in  particular  its  ability  to  achieve  the  desired 
quality of design and of product, including control of products which fail 
to conform, 

where the design, manufacture and/or final inspection and testing of the 
products,  or  elements  thereof,  is  carried  out  by  another  party,  the 
methods of monitoring the efficient operation of the quality management 
system  and  in  particular  the  type  and  extent  of  control  applied  to  the 
other party, 

where the manufacturer does not have a registered place of business in a 
Member  State,  the  draft  mandate  for  the  designation  of  an  authorised 
representative and a letter of intention of the authorised representative to 
accept the mandate;  

(c) 

the  procedures  and  techniques  for  monitoring,  verifying,  validating  and 
controlling 
the  corresponding 
the  devices, 
documentation  as  well  as  the  data  and  records  arising  from  those  procedures 
and techniques; 

the  design  of 

including 

(d) 

the inspection and quality assurance techniques at the manufacturing stage and 
in particular: 

– 

the processes and procedures which will be used, particularly as regards 
sterilisation, purchasing and the relevant documents, 

EN 

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– 

the product identification procedures drawn up and kept up to date from 
drawings,  specifications  or  other  relevant  documents  at  every  stage  of 
manufacture; 

(e) 

the  appropriate  tests  and  trials  which  will  be  carried  out  before,  during  and 
after manufacture, the frequency with which they will take place, and the test 
equipment  used;  it  shall  be  possible  to  trace  back  the  calibration  of  the  test 
equipment adequately. 

In  addition,  the  manufacturer  shall  grant  the  notified  body  access  to  the  technical 
documentation referred to in Annex II. 

3.3. 

Audit 

(a)  The  notified  body  shall  audit  the  quality  management  system  to  determine 
whether  it  meets  the  requirements  referred  to  in  Section  3.2.  Unless  duly 
substantiated, it shall presume that quality management systems which satisfy 
the relevant harmonised standards or CTS conform to the requirements covered 
by the standards or CTS. 

(b)  The assessment team shall include at least one member with past experience of 
assessments  of  the  technology  concerned.  The  assessment  procedure  shall 
include  an  audit  on  the  manufacturer's  premises  and,  if  appropriate,  on  the 
premises  of  the  manufacturer's  suppliers  and/or  subcontractors  to  inspect  the 
manufacturing and other relevant processes. 

(c)  Moreover, in the case of devices falling into class IIa or IIb the audit procedure 
shall  include  an  assessment,  on  a  representative  basis,  of  the  design 
documentation within the technical documentation as referred to in Annex II of 
the device(s) concerned. In choosing representative sample(s) the notified body 
shall  take  into  account  the  novelty  of  the  technology,  similarities  in  design, 
technology, manufacturing and sterilisation methods, the intended use and the 
results  of  any  previous  relevant  assessments  (e.g.  with  regard  to  physical, 
chemical  or  biological  properties)  that  have  been  carried  out  in  accordance 
with  this  Regulation.  The  notified  body  shall  document  its  rationale  for  the 
sample(s) taken. 

(d) 

If  the  quality  management  system  conforms  to  the  relevant  provisions  of  this 
Regulation,  the  notified  body  shall  issue  an  EU  full  quality  assurance 
certificate. The decision shall be notified to the manufacturer. It shall contain 
the conclusions of the audit and a reasoned assessment. 

3.4. 

The  manufacturer  shall  inform  the  notified  body  which  approved  the  quality 
management system of any plan for substantial changes to the quality management 
system  or  the  product-range  covered.  The  notified  body  shall  assess  the  changes 
proposed and verify whether after these changes the quality management system still 
meets the requirements referred to in Section 3.2. It shall notify the manufacturer of 
its  decision  which  shall  contain  the  conclusions  of  the  audit  and  a  reasoned 
assessment.  The  approval  of  any  substantial  change  to  the  quality  management 
system or the product-range covered shall take the form of a supplement to the EU 
full quality assurance certificate. 

EN 

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4. 

Surveillance assessment 

4.1. 

4.2. 

The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations 
imposed by the approved quality management system. 

The  manufacturer  shall  authorise  the  notified  body  to  carry  out  all  the  necessary 
audits,  including  inspections,  and  supply  it  with  all  relevant  information,  in 
particular: 

– 

– 

– 

– 

the documentation on the quality management system, 

the  documentation  on  the  post-market  surveillance  plan,  including  a  post-
market clinical follow-up, as well as, if applicable, any findings resulting from 
the application of the post-market surveillance plan, including the post-market 
clinical follow-up, and of the provisions on vigilance set out in Articles 61 to 
66, 

the  data  stipulated  in  the  part  of  the  quality  management  system  relating  to 
design, such as the results of analyses, calculations, tests, the solutions adopted 
regarding  the  risk-management  as  referred  to  in  Section  2  of  Annex  I  ,  pre-
clinical and clinical evaluation, 

the  data  stipulated  in  the  part  of  the  quality  management  system  relating  to 
manufacture,  such  as  inspection  reports  and  test  data,  calibration  data, 
qualification reports of the personnel concerned, etc. 

The  notified  body  shall  periodically,  at  least  once  every  12  months,  carry  out 
appropriate  audits  and  assessments  to  make  sure  that  the  manufacturer  applies  the 
approved  quality  management  system  and  the  post-market  surveillance  plan,  and 
shall  supply  the  manufacturer  with  an  assessment  report.  This  shall  include 
inspections  on  the  premises  of  the  manufacturer  and,  if  appropriate,  of  the 
manufacturer's suppliers and/or subcontractors. At the time of such inspections, the 
notified body shall, where necessary, carry out or ask for tests in order to check that 
the  quality  management  system  is  working  properly.  It  shall  provide  the 
manufacturer with an inspection report and, if a test has been carried out, with a test 
report. 

if  appropriate,  of 

The  notified  body  shall  randomly  perform  unannounced  factory  inspections  to  the 
the  manufacturer's  suppliers  and/or 
manufacturer  and, 
subcontractors,  which  may  be  combined  with  the  periodic  surveillance  assessment 
referred to in Section 4.3. or be performed in addition to this surveillance assessment. 
The notified body shall establish a plan for the unannounced inspections which must 
not be disclosed to the manufacturer.  

Within the context of such unannounced inspections, the notified body shall check an 
adequate sample from the production or the manufacturing process to verify that the 
manufactured device is in conformity with the technical documentation and/or design 
dossier.  Prior  to  the  unannounced  inspection,  the  notified  body  shall  specify  the 
relevant sampling criteria and testing procedure.  

Instead of, or in addition to, the sampling from the production, the notified body shall 
take samples of devices from the market to verify that the manufactured device is in 

4.3. 

4.4. 

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conformity  with  the  technical  documentation  and/or  design  dossier.  Prior  to  the 
sampling,  the  notified  body  shall  specify  the  relevant  sampling  criteria  and  testing 
procedure. 

The  notified  body  shall  provide  the  manufacturer  with  an  inspection  report  which 
shall include, if applicable, the result of the sample check. 

4.5. 

In the case of devices classified as class IIa or class IIb, the surveillance assessment 
shall  also  include  the  assessment  of  the  design  documentation  within  the  technical 
documentation  of  the  device(s)  concerned  on  the  basis  of  further  representative 
sample(s) chosen in accordance with the rationale documented by the notified body 
in accordance with point (c) of Section 3.3.  

In  the  case  of  devices  classified  as  class  III,  the  surveillance  assessment  shall  also 
include  a  check  of  the  approved  parts  and/or  materials  that  are  essential  for  the 
integrity  of  the  device,  including,  where  appropriate,  the  coherence  between  the 
quantities  of  produced  or  purchased  parts  and/or  materials  and  the  quantities  of 
finished products.  

The notified body shall ensure that the composition of the assessment team assures 
experience with the technology concerned, continuous objectivity and neutrality; this 
shall  include  a  rotation  of  the  members  of  the  assessment  team  at  appropriate 
intervals. As a general rule, a lead auditor shall not lead and attend an audit for more 
than three consecutive years in respect to the same manufacturer.  

If  the  notified  body  establishes  a  divergence  between  the  sample  taken  from  the 
production  or  from  the  market  and  the  specifications  laid  down  in  the  technical 
documentation  or  the  approved  design,  it  shall  suspend  or  withdraw  the  relevant 
certificate or impose restrictions on it.  

Chapter II: Design dossier examination 

Examination  of  the  design  of  the  device,  applicable  to  devices  classified  as  
class III 

In  addition  to  the  obligations  imposed  by  Section  3,  the  manufacturer  shall  lodge 
with the notified body referred to in Section 3.1 an application for examination of the 
design dossier relating to the device which he plans to manufacture and which falls 
into  the  device  category  covered  by  the  quality  management  system  referred  to  in 
Section 3. 

The  application  shall  describe  the  design,  manufacture  and  performances  of  the 
device  in  question.  It  shall  include  the  technical  documentation  as  referred  to  in 
Annex II; where the technical documentation is voluminous and/or held in different 
locations, the manufacturer shall submit a summary technical documentation (STED) 
and grant access to the full technical documentation upon request. 

The  notified  body  shall  examine  the  application  employing  staff  with  proven 
knowledge  and  experience  regarding  the  technology  concerned.  The  notified  body 
may  require  the  application  to  be  completed  by  further  tests  or  other  evidence  to 
allow  assessment  of  conformity  with  the  requirements  of  the  Regulation.  The 

4.6. 

4.7. 

5. 

5.1. 

5.2. 

5.3. 

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5.4. 

5.5. 

notified body shall carry out adequate physical or laboratory tests in relation to the 
device or request the manufacturer to carry out such tests.  

The  notified  body  shall  provide  the  manufacturer  with  an  EU  design-examination 
report. 

If the device conforms to the relevant provisions of this Regulation, the notified body 
shall  issue  an  EU  design-examination  certificate.  The  certificate  shall  contain  the 
conclusions  of  the  examination,  the  conditions  of  validity,  the  data  needed  for 
identification  of  the  approved  design,  where  appropriate,  a  description  of  the 
intended purpose of the device. 

Changes to the approved design shall receive further approval from the notified body 
which  issued  the  EU  design-examination  certificate  wherever  the  changes  could 
affect  conformity  with  the  general  safety  and  performance  requirements  of  the 
Regulation  or  with  the  conditions  prescribed  for  use  of  the  device.  The  applicant 
shall inform the notified body which issued the EU design-examination certificate of 
any  planned  changes  to  the  approved  design.  The  notified  body  shall  examine  the 
planned  changes,  notify  the  manufacturer  of  its  decision  and  provide  him  with  a 
supplement to the EU design-examination report. The approval of any change to the 
approved design shall take the form of a supplement to the EU design-examination 
certificate.  

6. 

Specific procedures 

6.1. 

Procedure in the case of devices incorporating a medicinal substance  

(a)  Where  a  device  incorporates,  as  an  integral  part,  a  substance  which,  if  used 
separately, may be considered to be a medicinal product within the meaning of 
Article 1 of Directive 2001/83/EC, including a medicinal product derived from 
human blood or human plasma, with action ancillary to that of the device, the 
quality, safety and usefulness of the substance shall be verified by analogy with 
the methods specified in Annex I to Directive 2001/83/EC.  

(b)  Before  issuing  an  EU  design-examination  certificate,  the  notified  body  shall, 
having verified the usefulness of the substance as part of the device and taking 
account  of  the  intended  purpose  of  the  device,  seek  a  scientific  opinion  from 
one  of  the  competent  authorities  designated  by  the  Member  States  in 
accordance  with  Directive  2001/83/EC  (hereinafter  referred  to  as  'medicinal 
products competent authority') or the European Medicines Agency (hereinafter 
referred  to  as  ‘EMA’),  acting  particularly  through  its  Committee  on  Human 
Medicinal Products in accordance with Regulation (EC) No 726/2004, on the 
quality  and  safety  of  the  substance  including  the  benefit/risk  of  the 
incorporation of the substance into the device. Where the device incorporates a 
human blood or plasma derivative or a substance that, if used separately may 
be considered to be a medicinal product falling exclusively within the scope of 
the Annex of Regulation (EC) No 726/2004, the notified body shall consult the 
EMA.  

(c)  When  issuing  its  opinion,  the  medicinal  products  competent  authority  or  the 
EMA shall take into account the manufacturing process and the data related to 

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the usefulness of incorporation of the substance into the device as determined 
by the notified body. 

(d)  The  opinion  of  the  medicinal  products competent  authority  or  the  EMA  shall 

be drawn up  

– 

within  150  days  after  receipt  of  valid  documentation  if  the  substance 
subject  to  the  consultation  is  authorised  in  accordance  with  Directive 
2001/83/EC; or  

– 

within 210 days after receipt of valid documentation in other cases.  

(e)  The  scientific  opinion  of  the  medicinal  products  competent  authority  or  the 
EMA, and any possible update, shall be included in the documentation of the 
notified  body  concerning  the  device.  The  notified  body  shall  give  due 
consideration to the views expressed in the scientific opinion when making its 
decision.  The  notified  body  shall  not  deliver  the  certificate  if  the  scientific 
opinion  is  unfavourable.  It  shall  convey  its  final  decision  to  the  medicinal 
products competent authority concerned or to the EMA. 

(f)  Before changes are made with respect to an ancillary substance incorporated in 
a  device,  in  particular  related  to  its  manufacturing  process,  the  manufacturer 
shall inform the notified body of the changes which shall consult the medicinal 
products  competent  authority  that  was  involved  in  the  initial  consultation,  in 
order  to  confirm  that  the  quality  and  safety  of  the  ancillary  substance  are 
maintained. The medicinal products competent authority shall take into account 
the  data  related  to  the  usefulness  of  incorporation  of  the  substance  into  the 
device as determined by the notified body, in order to ensure that the changes 
have  no  negative  impact  on  the  established  benefit/risk  of  the  addition  of  the 
substance in the device. It shall provide its opinion within 30 days after receipt 
of the valid documentation regarding the changes. 

(g)  When  the  medicinal  products  competent  authority  that  was  involved  in  the 
initial consultation has obtained information on the ancillary substance, which 
could  have  an  impact  on  the  established  benefit/risk  of  the  addition  of  the 
substance in the device, it shall provide the notified body with advice whether 
this information has an impact on the established benefit/risk of the addition of 
the  substance  in  the  device  or  not.  The  notified  body  shall  take  the  updated 
scientific  opinion  into  account  in  reconsidering  its  assessment  of  the 
conformity assessment procedure. 

6.2. 

Procedure in the case of devices manufactured utilising tissues or cells of human 
or  animal  origin,  or  their  derivatives,  that  are  non-viable  or  rendered  non-
viable 

(a)  For  devices  manufactured  utilising  tissues  or  cells  of  human  origin,  or  their 
derivatives, that are covered by this Regulation in accordance with point (e) of 
Article 1(2), the notified body shall, prior to issuing an EU design-examination 
certificate, submit to the competent authority designated by the Member State 
in  accordance  with  Directive  2004/23/EC  (hereinafter  referred  to  as  'human 
tissues and cells competent authority') in which it is established a summary of 

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the  preliminary  conformity  assessment  which  shall,  among  others,  provide 
information  about  the  non-viability  of  the  human  tissues  or  cells,  their 
donation, procurement and testing and the benefit/risk  of  the  incorporation of 
the human tissues or cells into the device. 

(b)  Within  90  days  after  receipt  of  valid  documentation,  the  human  tissues  and 
cells  competent  authority  may  submit  comments  on  aspects  related  to  the 
donation,  procurement  and  testing  and/or  the  benefit/risk  of  the  incorporation 
of the human tissues or cells into the device.  

(c)  The  notified  body  shall  give  due  consideration  to  any  comments  received  in 
accordance  with  point  (b).  It  shall  convey  to  the  human  tissues  and  cells 
competent authority an explanation as regards this consideration, including any 
due  justification  not  to  follow  the  comment  received,  and  its  final  decision 
regarding the conformity assessment in question. The comments of the human 
tissues and cells competent authority shall be included in the documentation of 
the notified body concerning the device.  

7. 

Batch  verification  in  the  case  of  devices  incorporating  a  medicinal  substance 
which, if used separately, may be considered to be a medicinal product derived 
from human blood or human plasma referred to in Article 1(4) 

Upon  completing  the  manufacture  of  each  batch  of  devices  that  incorporate  a 
medicinal substance which, if used separately, may be considered to be a medicinal 
product  derived  from  human  blood  or  human  plasma  referred  to  in  the  first 
subparagraph of Article 1(4), the manufacturer shall inform the notified body of the 
release  of  the  batch  of  devices  and  send  to  it  the  official  certificate  concerning  the 
release of the batch of human blood or plasma derivative used in the device, issued 
by a State laboratory or a laboratory designated for that purpose by a Member State 
in accordance with Article 114(2) of Directive 2001/83/EC. 

Chapter III: Administrative provisions 

8. 

The manufacturer or his authorised representative shall, for a period ending at least 
five  years,  and  in  the  case  of  implantable  devices  at  least  15  years,  after  the  last 
device  has  been  placed  on  the  market,  keep  at  the  disposal  of  the  competent 
authorities:  

– 

– 

– 

– 

– 

the declaration of conformity, 

the  documentation  referred  to  in  the  fourth  indent  of  Section  3.1  and  in 
particular the data and records arising from the procedures referred to in point 
(c) of Section 3.2,  

the changes referred to in Section 3.4, 

the documentation referred to in Section 5.2, and 

the decisions and reports from the notified body as referred to in Sections 3.3, 
4.3, 4.4. 5.3, 5.4. and 5.5.  

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9. 

Each  Member  State  shall  make  provision  that  this  documentation  is  kept  at  the 
disposal of the competent authorities for the period indicated in the first sentence of 
the  preceding  paragraph  in  case  the  manufacturer,  or  his  authorised  representative, 
established within its territory goes bankrupt or ceases its business activity prior to 
the end of this period. 

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CONFORMITY ASSESSEMENT BASED ON TYPE EXAMINATION 

ANNEX IX  

1. 

EU  type-examination  is  the  procedure  whereby  a  notified  body  ascertains  and 
certifies  that  a  representative  sample  of  the  production  covered  fulfils  the  relevant 
provisions of this Regulation. 

2. 

Application 

The application shall include: 

– 

– 

– 

the name and address of the manufacturer and, if the application is lodged by 
the  authorised  representative,  the  name  and  address  of  the  authorised 
representative, 

the  technical  documentation  referred  to  in  Annex  II  needed  to  assess  the 
conformity  of  the  representative  sample  of  the  production  in  question, 
hereinafter referred to as the ‘type’, with the requirements of this Regulation; 
where  the  technical  documentation  is  voluminous  and/or  held  in  different 
locations,  the  manufacturer  shall  submit  a  summary  technical  documentation 
(STED) and grant access to the full technical documentation upon request. The 
applicant shall make a ‘type’ available to the notified body. The notified body 
may request other samples as necessary,  

a  written  declaration  that  no  application  has  been  lodged  with  any  other 
notified body for the same type, or information about any previous application 
for the same type that has been refused by another notified body. 

3. 

Assessment 

The notified body shall: 

3.1. 

3.2. 

examine  and  assess  the  technical  documentation  and  verify  that  the  type  has  been 
manufactured  in  conformity  with  that  documentation;  it  shall  also  record  the  items 
designed in conformity with the applicable specifications of the standards referred to 
in Article 6 or CTS , as well as the items not designed on the basis of the relevant 
provisions of the abovementioned standards; 

carry  out  or  arrange  for  the  appropriate  assessments  and  the  physical  or  laboratory 
tests necessary to verify whether the solutions adopted by the manufacturer meet the 
general  safety  and  performance  requirements  of  this  Regulation  if  the  standards 
referred to in Article 6 or CTS have not been applied; if the device is to be connected 
to  other  device(s)  in  order  to  operate  as  intended,  proof  shall  be  provided  that  it 
conforms to the general safety and performance requirements when connected to any 
such device(s) having the characteristics specified by the manufacturer; 

3.3. 

carry  out  or  arrange  for  the  appropriate  assessments  and  the  physical  or  laboratory 
tests  necessary  to  verify  whether,  if  the  manufacturer  has  chosen  to  apply  the 
relevant standards, these have actually been applied; 

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3.4. 

agree with the applicant on the place where the necessary assessments and tests will 
be carried out. 

4. 

Certificate 

If the type conforms to the provisions of this Regulation, the notified body shall issue 
an  EU  type-examination  certificate.  The  certificate  shall  contain  the  name  and 
address  of  the  manufacturer,  the  conclusions  of  the  assessment,  the  conditions  of 
validity  and  the  data  needed  for  identification  of  the  type  approved.  The  relevant 
parts of the documentation shall be annexed to the certificate and a copy kept by the 
notified body. 

5. 

Changes to the type 

5.1. 

5.2. 

The applicant shall inform the notified body which issued the EU type-examination 
certificate of any planned change to the approved type.  

Changes  to  the  approved  product  shall  receive  further  approval  from  the  notified 
body  which  issued  the  EU  type-examination  certificate  wherever  the  changes  may 
affect conformity with the general safety and performance requirements or with the 
conditions  prescribed  for  use  of  the  product.  The  notified  body  shall  examine  the 
planned  changes,  notify  the  manufacturer  of  its  decision  and  provide  him  with  a 
supplement  to  the  EU  type-examination  report.  The  approval  of  any  change  to  the 
approved type shall take the form of a supplement to the initial EU type-examination 
certificate.  

6. 

Specific procedures  

The provisions regarding the specific procedures in the case of devices incorporating 
a medicinal substance, or devices manufactured utilising tissues or cells of human or 
animal origin, or their derivatives, that are non-viable or rendered non-viable set out 
in Annex VIII, Section 6, apply with the proviso that any reference to an EU design-
examination certificate shall be understood as reference to an EU type-examination 
certificate.  

7. 

Administrative provisions 

The manufacturer or his authorised representative shall, for a period ending at least 
five  years,  and  in  the  case  of  implantable  devices  at  least  15  years,  after  the  last 
device  has  been  placed  on  the  market,  keep  at  the  disposal  of  the  competent 
authorities: 

– 

– 

– 

the documentation referred to in the second indent of Section 2, 

the changes referred to in Section 5,  

copies of EU type-examination certificates and their additions.  

Section 9 of Annex VIII shall apply. 

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ANNEX X  

CONFORMITY ASSESSEMENT BASED ON PRODUCT CONFORMITY 
VERIFICATION 

1. 

2. 

3. 

1. 

2. 

The objective of the conformity assessment based on product conformity verification 
is  to  ensure  that  devices  conform  to  the  type  for  which  an  EU  type-examination 
certificate has been issued and meet the provisions of this Regulation which apply to 
them.  

Where an EU type-examination certificate has been issued in accordance with Annex 
IX,  the  manufacturer  can  either  apply  the  procedure  set  out  in  part  A  (production 
quality assurance) or the procedure set out in part B (product verification).  

By  way  of  derogation  from  Sections  1  and  2,  this  Annex  can  also  be  applied  by 
manufacturers  of  devices  classified  as  class  IIa  coupled  with  the  drawing  up  of  a 
technical documentation as set out in Annex II.  

PART A: PRODUCTION QUALITY ASSURANCE 

The  manufacturer  shall  ensure  application  of  the  quality  management  system 
approved  for  the  manufacture  of  the  devices  concerned  and  carry  out  the  final 
inspection, as specified in Section 3, and is subject to the surveillance referred to in 
Section 4. 

The manufacturer who fulfils the obligations imposed by Section 1 shall draw up and 
keep an EU declaration of conformity in accordance with Article 17 and Annex III 
for the device model covered by the conformity assessment procedure. By issuing an 
EU declaration of conformity the manufacturer ensures and declares that the devices 
concerned conform to the type described in the EU type-examination certificate and 
meet the provisions of this Regulation which apply to them. 

3. 

Quality management system 

3.1. 

The  manufacturer  shall  lodge  an  application  for  assessment  of  his  quality 
management system with a notified body. The application shall include: 

– 

– 

– 

all elements listed in Section 3.1 of Annex VIII,  

the technical documentation as referred to in Annex II for the types approved; 
where  the  technical  documentation  is  voluminous  and/or  held  in  different 
locations,  the  manufacturer  shall  submit  a  summary  technical  documentation 
(STED) and grant access to the full technical documentation upon request;  

a  copy  of  the  EU-type  examination  certificates  referred  to  in  Section  4  of 
Annex  IX;  if  the  EU-type  examination  certificates  have  been  issued  by  the 
same  notified  body  with  which  the  application  is  lodged,  a  reference  to  the 
technical documentation and the certificates issued is sufficient.  

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3.2. 

Application of the quality management system shall ensure that the devices conform 
to the type described in the EU type-examination certificate and to the provisions of 
this  Regulation  which  apply  to them  at  every stage. All the elements, requirements 
and provisions adopted by the manufacturer for his quality management system shall 
be  documented  in  a  systematic  and  orderly  manner  in  the  form  of  written  policies 
and  procedures  such  as  quality  programmes,  quality  plans,  quality  manuals  and 
quality records. 

It shall, in particular, include an adequate description of all elements listed in points 
(a), (b), (d) and (e) of Section 3.2 of Annex VIII.  

3.3. 

The provisions of points (a) and (b) of Section 3.3 of Annex VIII apply.  

If  the  quality  management  system  ensures  that  the  devices  conform  to  the  type 
described  in  the  EU  type-examination  certificate  and  conforms  to  the  relevant 
provisions of this Regulation, the notified body shall issue an EU quality assurance 
certificate.  The  decision  shall  be  notified  to  the  manufacturer.  It  shall  contain  the 
conclusions of the inspection and a reasoned assessment. 

3.4. 

The provisions of Section 3.4 Annex VIII apply.  

4. 

Surveillance 

The  provisions  of  Section  4.1,  the  first,  second  and  fourth  indents  of  Section  4.2, 
Section 4.3, Section 4.4, Section 4.6 and Section 4.7 of Annex VIII apply. 

In  the  case  of  devices  classified  as  class  III,  the  surveillance  shall  also  include  a 
check of the coherence between the quantity of produced or purchased raw material 
or crucial components approved for the type and the quantity of finished products. 

5. 

Batch  verification  in  the  case  of  devices  incorporating  a  medicinal  substance 
which, if used separately, may be considered to be a medicinal product derived 
from human blood or human plasma referred to in Article 1(4) 

Upon  completing  the  manufacture  of  each  batch  of  devices  that  incorporate  a 
medicinal substance which, if used separately, may be considered to be a medicinal 
product  derived  from  human  blood  or  human  plasma  referred  to  in  the  first 
subparagraph of Article 1(4), the manufacturer shall inform the notified body of the 
release  of  the  batch  of  devices  and  send  to  it  the  official  certificate  concerning  the 
release of the batch of human blood or plasma derivative used in the device, issued 
by a State laboratory or a laboratory designated for that purpose by a Member State 
in accordance with Article 114(2) of Directive 2001/83/EC. 

6. 

Administrative provisions 

The manufacturer or his authorised representative shall, for a period ending at least 
five  years,  and  in  the  case  of  implantable  devices  at  least  15  years,  after  the  last 
device  has  been  placed  on  the  market,  keep  at  the  disposal  of  the  competent 
authorities:  

– 

the declaration of conformity, 

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– 

– 

– 

– 

the documentation referred to in the fourth indent of Section 3.1 of Annex VIII,  

the  documentation  referred  to  in  the  seventh  indent  of  Section  3.1  of  Annex 
VIII, including the EU type-examination certificate referred to in Annex IX, 

the changes referred to in Section 3.4 of Annex VIII, and 

the decisions and reports from the notified body as referred to in Sections 3.3, 
4.3 and 4.4 of Annex VIII. 

Section 9 of Annex VIII shall apply. 

7. 

Application to devices classified as class IIa 

7.1. 

7.2. 

7.3. 

7.4. 

7.5. 

By way of derogation from Section 2, by virtue of the EU declaration of conformity 
the manufacturer ensures and declares that the devices in class IIa are manufactured 
in conformity with the technical documentation referred to in Annex II and meet the 
requirements of this Regulation which apply to them. 

For  devices  in  class  IIa  the  notified  body  shall  assess,  as  part  of  the  assessment  in 
Section  3.3,  on  a  representative  basis,  the  technical  documentation  as  referred  in 
Annex II for compliance with the provisions of this Regulation; where the technical 
documentation  is  voluminous  and/or  held  in  different  locations,  the  manufacturer 
shall submit a summary technical documentation (STED) and grant access to the full 
technical documentation upon request.  

In  choosing  representative  sample(s)  the  notified  body  shall  take  into  account  the 
novelty  of  the  technology,  similarities  in  design,  technology,  manufacturing  and 
sterilisation  methods,  the  intended  use  and  the  results  of  any  previous  relevant 
assessments (e.g. with regard to physical, chemical or biological properties) that have 
been  carried  out  in  accordance  with  this  Regulation.  The  notified  body  shall 
document its rationale for the sample(s) taken. 

If the assessment in accordance with Section 7.2. confirms that the devices in class 
IIa  conform  to  the  technical  documentation  referred  to  in  Annex  II  and  meet  the 
requirements of this Regulation which apply to them, the notified body shall issue a 
certificate pursuant to this section of this Annex.  

Further  samples  shall  be  assessed  by  the  notified  body  as  part  of  the  surveillance 
assessment referred to in Section 4. 

By  way  of  derogation  from  Section  6,  the  manufacturer  or  his  authorised 
representative  shall,  for  a  period  ending  at  least  five  years  after  the  last  device  has 
been placed on the market, keep at the disposal of the competent authorities:  

– 

– 

– 

the declaration of conformity, 

the technical documentation referred to in Annex II, 

the certificate referred to in Section 7.3. 

Section 9 of Annex VIII shall apply. 

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1. 

2. 

3. 

4. 

5. 

5.1. 

5.2. 

6. 

PART B: PRODUCT VERIFICATION 

is 

Product  verification 
the  procedure  whereby  after  examination  of  every 
manufactured device the manufacturer, by issuing a EU declaration of conformity in 
accordance  with  Article  17  and  Annex  III,  ensures  and  declares  that  the  devices 
which have been subject to the procedure set out in Sections 4 and 5 conform to the 
type described in the EU type-examination certificate and meet the requirements of 
this Regulation which apply to them. 

The  manufacturer  shall  take  all  the  measures  necessary  to  ensure  that  the 
manufacturing process produces devices which conform to the type described in the 
EU  type-examination  certificate  and  to  the  requirements  of  the  Regulation  which 
apply  to  them.  Before  the  start  of  manufacture,  the  manufacturer  shall  prepare 
documents  defining  the  manufacturing  process,  in  particular  as  regards  sterilisation 
where  necessary,  together  with  all  the  routine,  pre-established  provisions  to  be 
implemented to ensure homogeneous production and, where appropriate, conformity 
of  the  products  with  the  type  described  in  the  EU  type-examination  certificate  and 
with the requirements of this Regulation which apply to them.  

In addition, for devices placed on the market in sterile condition, and only for those 
aspects  of  the  manufacturing  process  designed  to  secure  and  maintain  sterility,  the 
manufacturer shall apply the provisions of Sections 3 and 4 of Part A of this Annex. 

The  manufacturer  shall  undertake  to  institute  and  keep  up  to  date  a  post-market 
surveillance  plan,  including  a  post-market  clinical  follow-up,  and  the  procedures 
ensuring compliance with the obligations emanating from the provisions on vigilance 
set out in Articles 61 to 66.  

The notified body shall carry out the appropriate examinations and tests in order to 
verify  the  conformity  of  the  device  with  the  requirements  of  the  Regulation  by 
examining and testing every product as specified in Section 5. 

The  aforementioned  checks  do  not  apply  to  those  aspects  of  the  manufacturing 
process designed to secure sterility. 

Verification by examination and testing of every product 

Every  device  is  examined  individually  and  the  appropriate  physical  or  laboratory 
tests  defined  in  the  relevant  standard(s)  referred  to  in  Article  6  or  equivalent  tests 
shall  be  carried  out  in  order  to  verify,  where  appropriate,  the  conformity  of  the 
devices with the type described in the EU type-examination certificate and with the 
requirements of this Regulation which apply to them. 

The  notified  body  shall  affix,  or  have  affixed  its  identification  number  to  each 
approved device and shall draw up an EU product verification certificate relating to 
the tests carried out. 

Batch  verification  in  the  case  of  devices  incorporating  a  medicinal  substance 
which, if used separately, may be considered to be a medicinal product derived 
from human blood or human plasma referred to in Article 1(4) 

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Upon  completing  the  manufacture  of  each  batch  of  devices  that  incorporate  a 
medicinal substance which, if used separately, may be considered to be a medicinal 
product  derived  from  human  blood  or  human  plasma  referred  to  in  the  first 
subparagraph of Article 1(4), the manufacturer shall inform the notified body of the 
release  of  the  batch  of  devices  and  send  to  it  the  official  certificate  concerning  the 
release of the batch of human blood or plasma derivative used in the device, issued 
by a State laboratory or a laboratory designated for that purpose by a Member State 
in accordance with Article 114(2) of Directive 2001/83/EC. 

7. 

Administrative provisions 

The manufacturer or his authorised representative shall, for a period ending at least 
five  years,  and  in  the  case  of  implantable  devices  at  least  15  years,  after  the  last 
device  has  been  placed  on  the  market,  keep  at  the  disposal  of  the  competent 
authorities:  

– 

– 

– 

– 

the declaration of conformity, 

the documentation referred to in Section 2, 

the certificate referred to in Section 5.2, 

the EU type-examination certificate referred to in Annex IX. 

Section 9 of Annex VIII shall apply. 

8. 

Application to devices classified as class IIa 

8.1. 

8.2. 

8.3. 

8.4. 

By way of derogation from Section 1, by virtue of the EU declaration of conformity 
the manufacturer ensures and declares that the devices in class IIa are manufactured 
in conformity with the technical documentation referred to in Annex II and meet the 
requirements of this Regulation which apply to them. 

The  verification  conducted  by  the  notified  body  in  accordance  with  Section  4  is 
intended  to  confirm  the  conformity  of  the  devices  in  class  IIa  with  the  technical 
documentation referred to in Annex II and with the requirements of this Regulation 
which apply to them. 

If the verification in accordance with Section 8.2. confirms that the devices in class 
IIa  conform  to  the  technical  documentation  referred  to  in  Annex  II  and  meet  the 
requirements of this Regulation which apply to them, the notified body shall issue a 
certificate pursuant to this section of this Annex. 

By  way  of  derogation  from  Section  7,  the  manufacturer  or  his  authorised 
representative  shall,  for  a  period  ending  at  least  five  years  after  the  last  device  has 
been placed on the market, keep at the disposal of the competent authorities:  

– 

– 

the declaration of conformity, 

the technical documentation referred to in Annex II, 

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– 

the certificate referred to in Section 8.3. 

Section 9 of Annex VIII shall apply. 

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CONFORMITY ASSESSMENT PROCEDURE FOR CUSTOM-MADE DEVICES 

ANNEX XI 

1. 

For  custom-made  devices  the  manufacturer  or  his  authorised  representative  shall 
draw up the statement containing the following information: 

– 

– 

– 

– 

– 

– 

– 

– 

the name and address of the manufacturer, and of any additional manufacturing 
sites, 

if applicable, the name and address of the authorised representative,  

data allowing identification of the device in question, 

a statement that the device is intended for exclusive use by a particular patient 
or user, identified by name, an acronym or a numerical code, 

the  name  of  the  doctor  of  medicine,  dental  practitioner  or  any  other  person 
authorised by national law by virtue of this person's professional qualifications 
who  made  out  the  prescription  and,  where  applicable,  the  name  of  the  health 
institution concerned, 

the specific characteristics of the product as indicated by the prescription, 

a  statement  that  the  device  in  question  conforms  to  the  general  safety  and 
performance requirements set out in Annex I and, where applicable, indicating 
which  general  safety  and  performance  requirements  have  not  been  fully  met, 
together with the grounds, 

where  applicable,  an  indication  that  the  device  contains  or  incorporates  a 
medicinal substance, including a human blood or plasma derivative, or tissues 
or  cells  of  human  origin,  or  of  animal  origin  as  referred  to  in  Commission 
Regulation (EU) No 722/2012. 

2. 

3. 

The  manufacturer  shall  undertake  to  keep  available  for  the  competent  national 
authorities  the  documentation,  indicating  manufacturing  site(s)  and  allowing  an 
understanding of the design, manufacture and performances of the product, including 
the  expected  performances,  so  as  to  allow  assessment  of  conformity  with  the 
requirements of this Regulation. 

The  manufacturer  shall  take  all  the  measures  necessary  to  ensure  that  the 
manufacturing  process  produces  products  which  are  manufactured  in  accordance 
with the documentation mentioned in the first paragraph; 

The information contained in the declaration concerned by this Annex shall be kept 
for  a  period  of  time  of  at  least  five  years  after  the  device  has  been  placed  on  the 
market. In the case of implantable devices the period shall be at least 15 years. 

Section 9 of Annex VIII shall apply. 

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4. 

The manufacturer shall undertake to review and document experience gained in the 
post-production phase, including a PMCF referred to in Part B of Annex XIII, and to 
implement  appropriate  means  to  apply  any  necessary  corrective  action.  This 
undertaking shall include an obligation for the manufacturer to notify, in accordance 
with  Article  61(4)  the  competent  authorities  of  any  serious  incidents  and/or  field 
safety corrective actions immediately on learning of them. 

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ANNEX XII  

MINIMUM CONTENT OF CERTIFICATES ISSUED BY A NOTIFIED 
BODY 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

11. 

12. 

13. 

14. 

Name, address and identification number of the notified body; 

name  and  address  of  the  manufacturer  and,  if  applicable,  of  the  authorised 
representative; 

unique number identifying the certificate; 

date of issue;  

date of expiry;  

data needed for the identification of the device(s) or categories of devices covered by 
the  certificate,  including  the  intended  purpose  of  the  device(s)  and  the  GMDN 
code(s) or internationally recognised nomenclature code(s); 

if applicable, the manufacturing facilities covered by the certificate; 

reference  to  this  Regulation  and  the  relevant  Annex  according  to  which  the 
conformity assessment has been carried out; 

examinations and tests performed, e.g. reference to relevant standards / test reports / 
audit report(s); 

if applicable, reference to the relevant parts of the technical documentation or other 
certificates required for the placing on the market of the device(s) covered; 

if applicable, information about the surveillance by the notified body;  

conclusions of the notified body’s assessment, examination or inspection;  

conditions for or limitations to the validity of the certificate; 

legally  binding  signature  of  the  notified  body  according  to  the  applicable  national 
law. 

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ANNEX XIII 

CLINICAL EVALUATION AND POST-MARKET CLINICAL  
FOLLOW-UP 

PART A: CLINICAL EVALUATION  

1. 

To conduct a clinical evaluation, a manufacturer shall: 

– 

– 

– 

– 

– 

identify  the  general  safety  and  performance  requirements  that  require  support 
from relevant clinical data; 

identify  available  clinical  data  relevant  to  the  device  and  its  intended  use 
generated through scientific literature search, clinical experience and/or clinical 
investigations;  

appraise the clinical data sets by evaluating their suitability for establishing the 
safety and performance of the device; 

generate  any  new  or  additional  clinical  data  needed  to  address  outstanding 
issues; 

analyse  all  relevant  clinical  data  to  reach  conclusions  about  the  safety  and 
performance of the device. 

Confirmation of conformity with the requirements concerning the characteristics and 
performances referred to in Section 1 of Annex I, under the normal conditions of use 
of  the  device,  and  the  evaluation  of  the  undesirable  side-effects  and  of  the 
acceptability of the benefit/risk ratio referred to in Sections 1 and 5 of Annex I, shall 
be based on clinical data.  

The clinical evaluation shall be thorough and objective, considering both favourable 
and unfavourable data. Its depth and extent shall be proportionate and appropriate to 
the nature, classification, intended use, manufacturer’s claims and risks of the device 
in question.  

Clinical  data  relating  to  another  device  may  be  relevant  where  equivalence  is 
demonstrated of the device subject to clinical evaluation to the device to which the 
data relates. Equivalence can only be demonstrated when the device that is subject to 
clinical evaluation and the device to which the existing clinical data relates have the 
same  intended  purpose  and  when  the  technical  and  biological  characteristics  of  the 
devices  and  the  medical  procedures  applied  are  similar  to  such  an  extent  that  there 
would be not a clinically significant difference in the safety and performance of the 
devices.  

In  the  case  of  implantable  devices  and  devices  falling  within  class  III,  clinical 
investigations shall be performed unless it is duly justified to rely on existing clinical 
data  alone.  Demonstration  of  equivalence  in  accordance  with  Section  4  shall 

2. 

3. 

4. 

5. 

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generally not be considered as sufficient justification within the meaning of the first 
sentence of this paragraph. 

6. 

The results of the clinical evaluation and the clinical data on which it is based shall 
be documented in the clinical evaluation report which shall support the assessment of 
the conformity of the device.  

The clinical data together with non-clinical data generated from non-clinical testing 
methods  and  other  relevant  documentation  shall  allow  the  manufacturer  to 
demonstrate  conformity  with  the  general  safety  and  performance  requirements  and 
shall be part of the technical documentation of the device in question.  

PART B: POST-MARKET CLINICAL FOLLOW-UP  

1. 

2. 

2.1. 

Post-market clinical follow-up, hereinafter: PMCF, is a continuous process to update 
the clinical evaluation referred to in Article 49 and Part A of this Annex and shall be 
part  of  the  manufacturer's  post-market  surveillance  plan.  To  this  end,  the 
manufacturer shall proactively collect and evaluate clinical data from the use in or on 
humans of a device which is authorised to bear the CE marking, within its intended 
purpose as referred to in the relevant conformity assessment procedure, with the aim 
of  confirming  the  safety  and  performance  throughout  the  expected  lifetime  of  the 
device, the continued acceptability of identified risks and to detect emerging risks on 
the basis of factual evidence.  

The  PMCF  shall  be  performed  pursuant  to  a  documented  method  laid  down  in  a 
PMCF plan.  

The PMCF plan shall specify the methods and procedures to proactively collect and 
evaluate clinical data with the aim of  

(a) 

(b) 

confirming  the  safety  and  performance  of  the  device  throughout  its  expected 
lifetime, 

identifying previously unknown side-effects and monitoring the identified side-
effects and contra-indications,  

(c) 

identifying and analysing emergent risks on the basis of factual evidence,  

(d) 

(e) 

assuring  the  continued  acceptability  of  the  benefit/risk  ratio  referred  to  in 
Sections 1 and 5 of Annex I, and 

identifying  possible  systematic  misuse  or  off-label  use  of  the  device  with  a 
view to verify the correctness of its intended purpose. 

2.2. 

The PMCF plan shall lay down, in particular  

(a) 

the  general  methods  and  procedures  of  the  PMCF  to  be  applied,  such  as 
gathering  of  clinical  experience  gained,  feedback  from  users,  screening  of 
scientific literature and of other sources of clinical data;  

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(b) 

(c) 

(d) 

the specific methods and procedures of PMCF to be applied, such as evaluation 
of suitable registers or PMCF studies;  

a rationale for the appropriateness of the methods and procedures referred to in 
points (a) and (b);  

a reference to the relevant parts of the clinical evaluation report referred to in 
Section  6  of  Part  A  of  this  Annex  and  to  the  risk  management  referred  to  in 
Section 2 of Annex I; 

(e) 

the specific objectives to be addressed by the PMCF;  

(f) 

an evaluation of the clinical data related to equivalent or similar devices, 

(g) 

reference to relevant standards and guidance on PMCF.  

3. 

4. 

The manufacturer shall analyse the findings of the PMCF and document the results in 
a PMCF evaluation report that shall be part of the technical documentation. 

The  conclusions  of  the  PMCF  evaluation  report  shall  be  taken  into  account  for  the 
clinical evaluation referred to in Article 49 and Part A of this Annex and in the risk 
management referred to in Section 2 of Annex I. If through the PMCF the need for 
corrective measures has been identified, the manufacturer shall implement them. 

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ANNEX XIV  

CLINICAL INVESTIGATIONS 

I. General requirements 

1. 

Ethical considerations 

Every  step  in  the  clinical  investigation,  from  first  consideration  of  the  need  and 
justification  of  the  study  to  the  publication  of  the  results,  shall  be  carried  out  in 
accordance with recognised ethical principles, as for example those laid down in the 
World Medical Association Declaration of Helsinki on Ethical Principles for Medical 
Research  Involving  Human  Subjects,  adopted  by  the  18th  World  Medical 
Association  General  Assembly  in  Helsinki,  Finland,  in  1964,  and  last  amended  by 
the 59th World Medical Association General Assembly in Seoul, Korea, in 2008. 

2. 

Methods 

2.1. 

2.2. 

2.3. 

2.4. 

2.5. 

2.6. 

2.7. 

Clinical  investigations  shall  be  performed  on  the  basis  of  an  appropriate  plan  of 
investigation  reflecting  the  latest  scientific  and  technical  knowledge  and  defined  in 
such a way as to confirm or refute the manufacturer's claims for the device as well as 
the safety, performance and benefit/risk related aspects referred to in Article 50(1); 
these  investigations  shall  include  an  adequate  number  of  observations  to  guarantee 
the scientific validity of the conclusions. 

The procedures used to perform the investigations shall be appropriate to the device 
under examination. 

Clinical  investigations  shall  be  performed  in  circumstances  similar  to  the  normal 
conditions of use of the device. 

All  the  appropriate  features,  including  those  involving  the  safety  and  performances 
of the device, and its effect on patients shall be examined. 

The  investigations  shall  be  performed  under  the  responsibility  of  a  medical 
practitioner or another authorised qualified person in an appropriate environment. 

The medical practitioner or other authorised person shall have access to the technical 
and clinical data regarding the device. 

The  clinical  investigation  report,  signed  by  the  medical  practitioner  or  other 
authorised  person  responsible,  shall  contain  a  critical  evaluation  of  all  the  data 
collected during the clinical investigation, including negative findings. 

II. Documentation regarding the application for clinical investigation 

For  investigational  devices  covered  by  Article  50  the  sponsor  shall  draw  up  and  submit  the 
application  in  accordance  with  Article  51  accompanied  by  the  documentation  as  laid  down 
below:  

1. 

Application form 

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The application form shall be duly filled in, containing information regarding:  

1.1. 

1.2. 

Name,  address  and  contact  details  of  the  sponsor  and,  if  applicable,  name,  address 
and contact details of his contact person established in the Union. 

If  different  from  the  Section  1.1.,  name,  address  and  contact  details  of  the 
manufacturer  of  the  device  intended  for  clinical  investigation  and,  if  applicable,  of 
his authorised representative. 

1.3. 

Title of the clinical investigation.  

1.4. 

1.5. 

1.6. 

1.7. 

1.8. 

1.9. 

1.10. 

1.11. 

Single identification number in accordance with Article 51(1). 

Status  of  the  clinical  investigation  (e.g.  first  submission,  resubmission,  significant 
amendment). 

If resubmission with regard to same device, previous date(s) and reference number(s) 
of  earlier  submission(s)  or  in  the  case  of  significant  amendment,  reference  to  the 
original submission. 

If parallel submission for a clinical trial on a medicinal product in accordance with 
Regulation (EU) No […/…] [on clinical trials on medicinal products for human use], 
reference to the official registration number of the clinical trial.  

Identification of the Member States, EFTA countries, Turkey and third countries in 
which 
a 
multicentre/multinational study at the time of application.  

as  part  of 

investigation 

conducted 

shall  be 

clinical 

the 

Brief  description  of  the  investigational  device  (e.g.  name,  GMDN  code  or 
internationally  recognised  nomenclature  code,  intended  purpose,  risk  class  and 
applicable classification rule according to Annex VII). 

Information as to whether the device incorporates a medicinal substance, including a 
human blood or plasma derivative, or whether it is manufactured utilising non-viable 
tissues or cells of human or animal origin, or their derivatives.  

Summary of the clinical investigation plan (objective(s) of the clinical investigation, 
number and gender of subjects, criteria for subject selection, subjects under 18 years 
of  age,  design  of  the  investigation  such  as  controlled  and/or  randomised  studies, 
planned dates of commencement and of completion of the clinical investigation).  

1.12. 

If  applicable,  information  regarding  a  comparator  (e.g.  identification  of  the 
comparator device or medicinal product).  

2. 

Investigator’s Brochure  

The  investigator's  brochure  (IB)  shall  contain  the  clinical  and  non-clinical 
information  on  the  investigational  device  that  is  relevant  for  the  investigation  and 
available  at  the  time  of  application.  It  shall  be  clearly  identified  and  contain  in 
particular the following information:  

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2.1. 

Identification  and  description  of  the  device,  including  information  on  the  intended 
purpose, the risk classification and applicable classification rule according to Annex 
VII,  design  and  manufacturing  of  the  device  and  reference  to  previous  and  similar 
generations of the device. 

2.2.  Manufacturer's instructions for installation, and use, including storage and handling 
requirements,  as  well  as  the  label  and  instructions  for  use  to  the  extent  that  this 
information is available. 

2.3. 

Pre-clinical  testing  and  experimental  data,  in  particular  regarding  in  design 
calculations, in vitro tests, ex vivo tests, animal tests, mechanical or electrical tests, 
reliability tests, software verification and validation, performance tests, evaluation of 
biocompatibility and biological safety.  

2.4. 

Existing clinical data, in particular  

– 

– 

of the relevant scientific literature available relating to the safety, performance, 
design characteristics and intended purpose of the device and/or of equivalent 
or similar devices; 

of  other  relevant  clinical  data  available  relating  to  the  safety,  performance, 
design characteristics and intended purpose of equivalent or similar devices of 
the same manufacturer, including length of time on the market and a review of 
performance and safety related issues and any corrective actions taken; 

Summary of the risk/benefit analysis and the risk management, including information 
regarding known or foreseeable risks, any undesirable effects, contra-indications and 
warnings. 

In  the  case  of  devices  that  incorporates  a  medicinal  substance,  including  a  human 
blood  or  plasma  derivative,  or  devices  manufactured  utilising  non-viable  tissues  or 
cells  of  human  or  animal  origin,  or  their  derivatives,  detailed  information  on  the 
medicinal  substance  or  on  the  tissues  or  cells,  and  on  the  compliance  with  the 
relevant  general  safety  and  performance  requirements  and  the  specific  risk 
management in relation to the substance or tissues or cells.  

Reference to harmonised or other internationally recognised standards complied with 
in full or in part.  

A clause that any updates to the IB or any other relevant information that is newly 
available shall be brought to the attention of the investigators. 

2.5. 

2.6. 

2.7. 

2.8. 

3. 

Clinical Investigation Plan 

The clinical investigation plan (CIP) shall define the rationale, objectives, design and 
proposed  analysis,  methodology,  monitoring,  conduct  and  record-keeping  of  the 
clinical  investigation.  It  shall  contain  in  particular  the  information  as  laid  down 
below.  If  part  of  this  information  is  submitted  in  a  separate  document,  it  shall  be 
referenced in the CIP.  

3.1. 

General  

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3.1.1. 

Identification of the clinical investigation and the CIP. 

3.1.2. 

Identification of the sponsor. 

3.1.3. 

Information  on  the  principal  investigator,  coordinating  investigator,  including  their 
qualifications, and on the investigation site(s).  

3.1.4.  Overall synopsis of the clinical investigation. 

3.2. 

Identification  and  description  of  the  device,  including  its  intended  purpose,  its 
manufacturer,  its  traceability,  the  target  population,  materials  coming  into  contact 
with the human body, the medical or surgical procedures involved in its use and the 
necessary training and experience for its use.  

3.3. 

Justification for the design of the clinical investigation. 

3.4. 

Risks and benefits of the device and of the clinical investigation. 

3.5. 

Objectives and hypotheses of the clinical investigation.  

3.6. 

Design of the clinical investigation  

3.6.1.  General  information  such  as  type  of  investigation  with  rationale  for  choice, 

endpoints, variables. 

3.6.2. 

Information on the device to be used for the clinical investigation, on any comparator 
and on any other device or medication.  

3.6.3. 

Information on subjects, including size of investigation population and, if applicable, 
information on vulnerable populations.  

3.6.4.  Description of the procedures related to the clinical investigation. 

3.6.5.  Monitoring plan. 

3.7. 

Statistical considerations. 

3.8. 

Data management. 

3.9. 

Information about any amendments to the CIP. 

3.10. 

Policy regarding deviations from the CIP. 

3.11.  Accountability  regarding  the  device,  in  particular  control  of  access  to  the  device, 
follow-up in relation to the device used in the clinical investigation and the return of 
unused, expired or malfunctioning devices. 

3.12. 

Statement of compliance with the recognised ethical principles for medical research 
involving humans and the principles of good clinical practice in the field of clinical 
investigations  of  medical  devices  as  well  as  with  the  applicable  regulatory 
requirements. 

3.13. 

Informed consent process. 

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3.14. 

Safety reporting, including definitions of adverse events and serious adverse events, 
procedures and timelines for reporting.  

3.15.  Criteria  and  procedures  for  suspension  or  early  termination  of  the  clinical 

investigation. 

3.16. 

Policy  as  regards  the  establishment  of  the  clinical  investigation  report  and 
publication  of  results  in  accordance  with  the  legal  requirements  and  the  ethical 
principles referred to in Section 1 of Chapter I. 

3.17.  Bibliography. 

4. 

Other information 

4.1. 

A signed statement by the natural or legal person responsible for the manufacture of 
the investigational device that the device in question conforms to the general safety 
and  performance  requirements  apart  from  the  aspects  covered  by  the  clinical 
investigation and that, with regard to these aspects, every precaution has been taken 
to protect the health and safety of the subject.  

This statement may be supported by an attestation issued by a notified body. 

4.2.  Where  applicable  according  to  national  law,  copy  of  the  opinion(s)  of  the  ethics 

committee(s) concerned as soon as available. 

4.3. 

4.4. 

4.5. 

Proof of insurance cover or indemnification of subjects in case of injury, according 
to the national law. 

Documents and procedures to be used to obtain informed consent. 

Description of the arrangements to comply with the applicable rules on the protection 
and confidentiality of personal data, in particular: 

– 

– 

– 

organisational  and  technical  arrangements  that  will  be  implemented  to  avoid 
unauthorised access, disclosure, dissemination, alteration or loss of information 
and personal data processed; 

a description of measures that will be implemented to ensure confidentiality of 
records and personal data of subjects concerned in clinical investigations; 

a  description  of  measures  that  will  be  implemented  in  case  of  data  security 
breach in order to mitigate the possible adverse effects. 

III. Other sponsor’s obligations  

1. 

The sponsor shall undertake to keep available for the competent national authorities 
any documentation necessary to provide evidence for the documentation referred to 
in  Chapter  II  of  this  Annex.  If  the  sponsor  is  not  the  natural  or  legal  person 
responsible for the manufacture of the investigational device, this obligation may be 
fulfilled by that person on behalf of the sponsor. 

2. 

The reportable events shall be provided by the investigator(s) in timely conditions. 

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3. 

The documentation mentioned in this Annex shall be kept for a period of time of at 
least five years after the clinical investigation with the device in question has ended, 
or, when the device is subsequently placed on the market, at least five years after the 
last  device  has  been  placed  on  the  market.  In  the  case  of  implantable  devices  the 
period shall be at least 15 years.  

Each  Member  State  shall  make  provision  that  this  documentation  is  kept  at  the 
disposal of the competent authorities for the period indicated in the first sentence of 
the preceding paragraph in case the sponsor, or his contact person, established within 
its territory goes bankrupt or ceases its activity prior to the end of this period. 

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ANNEX XV 

LIST OF PRODUCTS COVERED BY THE LAST SUBPARAGRPAH OF THE DEFINITION 
OF ‘MEDICAL DEVICE’ REFERRED TO IN NUMBER (1) OF ARTICLE 2(1) 

1. 

2. 

3. 

4. 

5. 

6. 

Contact lenses;  

Implants for modification or fixation of body parts;  

Facial or other dermal or mucous membrane fillers; 

Equipment for liposuction; 

Invasive laser equipment intended to be used on the human body; 

Intense pulsed light equipment. 

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ANNEX XVI 

CORRELATION TABLE  

Council Directive 
90/385/EEC 

Council Directive 
93/42/EEC 

This Regulation 

Article 1(1) 

Article 1(2) 

Article 1(3) 

Article 1(1) 

Article 1(2) 

Article 1(1) 

Article 2(1) 

Article 1(3) 1st subparagraph  Article 1(5)1st subparagraph 

- 

Article 1(3) 2nd subparagraph  Article 1(5)2nd subparagraph 

Article 1(4) and (4a) 

Article 1(4) and (4a) 

Article 1(4)1st subparagraph 

Article 1(5) 

Article 1(6) 

- 

Article 2 

Article 1(7) 

Article 1(5) 

Article 1(6) 

Article 1(8) 

Article 2 

Article 3 1st subparagraph 

Article 3 1st subparagraph 

Article 1(6) 

Article 1(2) 

- 

Article 1(7) 

Article 4(1) 

Article 4(2) 

Article 3 2nd subparagraph 

Article 3 2nd subparagraph 

- 

Article 4(1) 

Article 4(2) 

Article 4(3) 

Article 4(4) 

Article 4(1) 

Article 4(2) 

Article 4(3) 

Article 4(4) 

Article 22 

Article 19(1) and (2) 

Article 19(3) 

Article 8(7) 

Article 4(5) point (a) 

Article 4(5) 1st subparagraph 

Article 18(6) 

Article 4(5) point (b) 

Article 4(5) 2nd subparagraph 

- 

Article 5(1) 

Article 5(2) 

Article 6(1) 

Article 6(2) 

Article 5(1) 

Article 5(2) 

Article 6(1)  

Article 6(2) 

Article 5(3), Article 6 

- 

Article 7(1) 

Article 88 

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Article 7 

- 

Article 8 

Article 9 

Articles 69 to 72 

Article 41 

Article 8(1) 

Article 10(1) 

Article 8(2) 

Article 10(2) 

Number (43) and (44) of 
Article 2(1), Article 61(1), 
Article 63(1) 

Article 61(3) and Article 
63(1)2nd subparagraph 

Article 10(3) 

Article 63(2) and (4) 

Article 8(3) 

Article 8(4) 

Article 9(1) 

- 

- 

- 

- 

Article 9(2) 

Article 9(3) 

Article 9(4) 

Article 9(5) 

Article 9(6) 

Article 9(7) 

Article 9(8) 

Article 9(9) 

Article 9(10) 

- 

- 

Article 10(4) 

Article 11(1) 

Article 11(2) 

Article 11(3) 

Article 11(4) 

Article 11(5) 

Article 11 (6) 

Article 11(8) 

Article 11(12) 

Article 11(7) 

Article 11(9) 

Article 11(10) 

Article 11(11) 

Article 11(13) 

Article 11(14) 

Article 12 

Article 12a 

Article 66 

Article 42(2) 

Article 42(4) 

Article 42(3) 

- 

Article 42(5) 

Article 42(7) 

Article 9(3) 

Article 42(8) 

- 

Article 43(1) 

Article 43(3) 

Article 45(2) 

Article 47(1) 

- 

Article 20 

Article 15 

- 

Article 9a(1) 1st indent 

Article 13(1) point (c) 

Article 9a(1) 2nd indent 

Article 13(1) point (d) 

Article 3(1) 

- 

Article 13(1) point (a) 

Article 41(3) 

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- 

Article 13(1) point (b) 

Article 41(4) point (a) 

Article 10 

Article 10a 

Article 10b 

Article 10c 

Article 11(1) 

Article 11(2) 

Article 11(3) 

Article 11(4) 

Article 11(5) 

Article 11(6) 

Article 11(7) 

Article 12 

Article 13 

Article 14 

Article 15 

Article 15a 

Article 16 

Article 17 

- 

Article 15 

Article 14 

Article 14a 

Article 14b 

Articles 50 to 60 

Article 25 

Article 27 

Article 74 

Article 16(1) 

Articles 33 and 34 

Article 16(2) 

Article 16(3) 

Article 16(4) 

Article 16(5) 

Article 16(6) 

Article 29 

Article 36(2) 

- 

Article 45(4) 

Article 45(3) 

Article 16(7) 

Articles 31(2) and 35(1) 

Article 17 

Article 18 

Article 19 

Article 20 

Article 20a 

Article 22 

Article 23 

Article 21 

Article 18 

Article 73 

Article 75 

Article 84 

Article 77 

- 

- 

- 

EN 

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   EN 

 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1.  Title of the proposal/initiative  

1.2.  Policy area(s) concerned in the ABM/ABB structure 

1.3.  Nature of the proposal/initiative  

1.4.  Objective(s)  

1.5.  Grounds for the proposal/initiative  

1.6.  Duration and financial impact  

1.7.  Management method(s) envisaged  

2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

2.2.  Management and control system  

2.3.  Measures to prevent fraud and irregularities  

3. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

3.1.  Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

3.2.  Estimated impact on expenditure  

3.2.1. Summary of estimated impact on expenditure  

3.2.2. Estimated impact on operational appropriations  

3.2.3. Estimated impact on appropriations of an administrative nature 

3.2.4. Compatibility with the current multiannual financial framework 

3.2.5. Third-party participation in financing  

3.3.  Estimated impact on revenue

EN 

175 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
LEGISLATIVE FINANCIAL STATEMENT 

1. 

FRAMEWORK OF THE PROPOSAL/INITIATIVE  

1.1. 

Title of the proposal/initiative  

Proposal for a Regulation of the European Parliament and of the Council on medical 
devices,  and  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  and 
Regulation (EC) No 1223/2009.  

This  financial  statement  also  includes  the  costs  related  to  the  Proposal  for  a 
Regulation  of  the  European  Parliament  and  of  the  Council  on  in  vitro  diagnostic 
medical  devices  which  is  based  on  the  same  organisational  and  IT  infrastructure 
established by this Proposal.  

1.2. 

Policy area(s) concerned in the ABM/ABB structure64  

Health for Growth 

1.3. 

Nature of the proposal/initiative  

X The proposal/initiative relates to a new action  

(cid:133)  The  proposal/initiative  relates  to  a  new  action  following  a  pilot  project/preparatory 
action65  

(cid:133) The proposal/initiative relates to the extension of an existing action  

(cid:133) The proposal/initiative relates to an action redirected towards a new action  

1.4. 

Objectives 

1.4.1.  The  Commission’s  multiannual 

strategic  objective(s) 

targeted  by 

the 

proposal/initiative  

In the field of medical devices, the proposals aim  

1) to ensure a high level of human health and safety,  

2) to ensure the functioning of the internal market, and  

3)  to  promote  innovation  in  medical  technology  for  the  benefit  of  patients  and 
healthcare professionals. 

64 
65 

ABM: Activity-Based Management – ABB: Activity-Based Budgeting. 
As referred to in Article 49(6)(a) or (b) of the Financial Regulation. 

EN 

176 

   EN 

 
                                                 
1.4.2. 

Specific objective(s) and ABM/ABB activity(ies) concerned  

Specific objective 1: Establish mechanisms to ensure harmonised implementation of 
the rules on medical devices by all Member States with a sustainable, efficient and 
credible  management  at  EU  level  with  access  to  internal  and  external  technical, 
scientific  and  clinical  expertise,  allowing  improved  coordination  and  resource-
sharing between Member States.  

Specific  objective  2:  Enhance  transparency  regarding  medical  devices  on  the  EU 
market, including their traceability.  

ABM/ABB activity(ies) concerned 

Health for Growth 

The Commission's Proposal for a Regulation of the European Parliament and of the 
Council  on  establishing  a  Health  for  Growth  Programme  for  the  period  2014-2020 
(COM[2011]709) lists contribution to the objectives of the EU legislation in the field 
of medical devices as one of the eligible actions to be financed by the programme.  

1.4.3.  Expected result(s) and impact 

Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 

On  patients  and  healthcare  professionals:  High  level  of  human  health  and  safety; 
cases  of  deliberate  circumvention  of  the  legal  requirements  (e.g.  PIP  case)  are 
prevented or quickly identified. High level of transparency and traceability regarding 
medical devices on the market (e.g. publicly accessible Eudamed; UDI; implant card; 
summary of safety and performance) allowing better informed decision-making and 
follow-up. High level of confidence in the EU regulations.  

On  manufacturers  of  medical  devices:  Level  playing  field  due  to  clearer  rules  and 
obligations,  benefiting  in  particular  the  large  majority  of  manufacturers  which 
already  comply  with  the  spirit  of  the  current  legislation.  Benefits  from  smoother 
functioning  of  the  internal  market.  Support  to  innovation  due  to  predictable 
regulatory  framework  conditions  (e.g.  early  scientific  advice).  Lower  overall 
administrative burdens due to central registration of devices and reporting of serious 
incidents.  

On  notified  bodies:  Safeguard  their  role  in  pre-market  medical  device  assessment. 
Level playing field due to clearer rules and obligations, benefiting in particular those 
notified  bodies  which  already  comply  with  the  spirit  of  the  current  legislation. 
Reinforcement of their position vis-à-vis manufacturers. 

On  national  authorities:  Reinforcement  of  their  enforcement  powers.  Clear  legal 
framework for coordination between them and resource- and work-sharing.  

1.4.4. 

Indicators of results and impact  

Specify the indicators for monitoring implementation of the proposal/initiative. 

Number of patients harmed by unsafe medical devices. 

EN 

177 

   EN 

 
Number  of  designated  notified  bodies,  their  areas  of  competence  and  the  level  of 
diversification.  

Number of registrations (medical devices, economic operators, certificates), incident 
reports,  single  applications  for  clinical  investigations  and  market  surveillance 
measures in the Eudamed databank with its several new electronic systems. 

Number  of  preliminary  conformity  assessments  "called  up"  under  the  scrutiny 
mechanism and number of comments emitted by MDCG. 

Number  of  coordinated  actions  between  national  competent  authorities  regarding 
post-market safety issues (vigilance and market surveillance). 

Number of 'borderline cases' solved.  

Number  of  devices  fitted  with  an  UDI  system  that  is  aligned  with  international 
practice. 

1.5. 

Grounds for the proposal/initiative  

1.5.1.  Requirement(s) to be met in the short or long term  

The  existing  regulatory  framework  is  being  criticised  for  not  sufficiently  ensuring 
patient  safety  within  the  internal  market  and  for  being  intransparent.  The  criticism 
has become even louder after findings of the French health authorities that a French 
manufacturer  (Poly  Implant  Prothèse,  PIP)  over  several  years  apparently  used 
industrial  silicone  instead  of  medical  grade  silicone  for  the  manufacture  of  breast 
implants  contrary  to  the  approval  provided  by  the  notified  body,  causing  harm  to 
thousands of women around the world.  

In an internal market with currently 32 participating countries (EU, EFTA, Turkey) 
and subject to constant technological and scientific progress, important divergences 
in the interpretation and application of the rules have emerged, thus undermining the 
directives'  main  objectives,  i.e.  the  safety  of  medical  devices  and  their  free 
circulation  within  the  internal  market.  Moreover,  regulatory  gaps  or  uncertainties 
exist with regard to certain products (e.g. products manufactured utilising non-viable 
human  tissues  or  cells;  implantable  or  other  invasive  products  for  cosmetic 
purposes).  

The  present  revision  aims  to  overcome  these  flaws  and  gaps  and  to  put  in  place  a 
robust, transparent and sustainable regulatory framework that is 'fit for purpose'. 

1.5.2.  Added value of EU involvement  

The proposed revision of the existing directives concerning medical devices, which 
will integrate the modification of the Lisbon Treaty regarding public health, can only 
be  achieved  at  Union  level.  The  proposals  are  based  on  Article  114  and  Article 
168(4)(c) of the Treaty on the Functioning of the European Union (TFEU).  

EU  action  is  necessary  to  improve  the  level  of  protection  of  public  health  for  all 
European  patients  and  users,  as  well  as  to  prevent  Member  States  from  adopting 

EN 

178 

   EN 

 
varying  product  regulations  which  would  result  in  a  further  fragmentation  of  the 
internal  market.  Harmonised  rules  and  procedures  allow  manufacturers,  especially 
SMEs that represent more than 80% of the sector, to reduce costs related to national 
regulatory  differences,  while  ensuring  a  high  and  equal  level  of  safety  for  all 
European patients and users. In accordance with the principles of proportionality and 
subsidiarity, as set out in Article 5 of  the Treaty on European Union,  this  proposal 
does not go beyond what is necessary to achieve those objectives. 

1.5.3.  Lessons learned from similar experiences in the past 

The existing directives concerning medical devices, which date back to the 1990ies, 
have  set  harmonised  requirements  to  be  met  by  medical  devices  placed  on  the  EU 
market.  But  they  have  not  provided  for  mechanisms  that  ensure  a  harmonised 
implementation.  As  mentioned  under  1.5.1., 
the 
interpretation  and  application  of  the  rules  have  emerged,  thus  undermining  the 
directives'  main  objectives,  i.e.  the  safety  of  medical  devices  and  their  free 
circulation within the internal market.  

important  divergences 

in 

In addition, lessons drawn from an analysis of the shortcomings brought to light by 
the PIP case have been taken into account for the drafting of these proposals.  

1.5.4.  Coherence and possible synergy with other relevant instruments 

Enhanced  coherence  is  expected  with  other  legislations  (e.g.  concerning  medicinal 
products, food, biocides, cosmetics) in terms of better delimitation of the respective 
scopes of application and/or in terms of solution of 'borderline cases'. 

Synergies  are  expected  with  the  legislation  regarding  medicinal  products,  in 
particular  as  regards  the  assessment  of  drug-device  combination  products  and  as 
regards clinical research regarding medicinal products (in the context of the revised 
Clinical  Trials  Directive)  and  regarding  medical  devices  (in  the  context  of  this 
proposal)  and/or  performance  evaluation  studies  with  IVDs  (in  the  context  of  the 
proposal for a Regulation on IVDs).  

EN 

179 

   EN 

 
1.6. 

Duration and financial impact  

(cid:133) Proposal/initiative of limited duration  

–  (cid:133)  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY  

–  (cid:133)  Financial impact from YYYY to YYYY  

X Proposal/initiative of unlimited duration 

–  Implementation with a start-up period from 2014 to 2017, 

–  followed by full-scale operation. 

1.7.  Management mode(s) envisaged66  

X Centralised direct management by the Commission  

(cid:133)  Centralised  indirect  management  with  the  delegation  of  implementation  tasks 
to: 

–  (cid:133)  executive agencies  

–  (cid:133)  bodies set up by the Communities67  

–  (cid:133)  national public-sector bodies/bodies with public-service mission  

–  (cid:133)  persons entrusted with the implementation of specific actions pursuant to Title 
V of the Treaty on European Union and identified in the relevant basic act within 
the meaning of Article 49 of the Financial Regulation  

(cid:133) Shared management with the Member States  

(cid:133) Decentralised management with third countries  

(cid:133) Joint management with international organisations (to be specified) 

If more than one management mode is indicated, please provide details in the "Comments" section. 

Comments  

The Commission intends to ensure the services concerned via centralised direct management 
through  its  own  services,  in  particular  via  the  JRC  for  the  technical,  scientific  and  logistic 
support.  

The  centralised  direct  management  by  the  Commission  also  applies  to  the  further 
development  and  management  of  Eudamed  (electronic  systems  regarding  UDI;  central 
registration  of  medical  devices,  economic  operators  and  certificates;  central  reporting  of 

66 

67 

Details  of  management  modes  and  references  to  the  Financial  Regulation  may  be  found  on  the 
BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html 
As referred to in Article 185 of the Financial Regulation. 

EN 

180 

   EN 

 
                                                 
vigilance cases; market surveillance measures; clinical investigations) and the IT tool for the 
notification of information regarding new applications for conformity assessment concerning 
high  risk  devices  by  notified  bodies  and  'called  up'  preliminary  assessments  by  them  in  the 
context of the scrutiny mechanism. 

It should be highlighted that the four EFTA countries (via EEA Agreement and MRA with 
CH) and Turkey (via Customs Union Agreement) will participate in the management.  

EN 

181 

   EN 

 
2. 

MANAGEMENT MEASURES  

2.1.  Monitoring and reporting rules  

Specify frequency and conditions. 

The future Medical Device Coordination Group (MDCG), set up by this Regulation, 
and  its  special  working  groups  will  provide  a  regular  platform  to  discuss  issues 
related to the implementation of the new regulatory framework.  

Ten  years  after  entry  into  force,  the  Commission  should  report  to  the  European 
Parliament  and  to  the  Council  about  the  achievements  of  the  'medical  device 
package'. The report should address the impact of the new rules in respect of public 
health and patient safety, internal market, innovativeness and competitiveness of the 
medical  device  industry  (with  special  attention  to  SMEs).  The  Commission  should 
consult  competent  authorities  and  stakeholders  (healthcare  professionals,  patients, 
manufacturers, notified bodies) when preparing its report. 

2.2.  Management and control system  

2.2.1.  Risk(s) identified  

Risks related to Eudamed: 

The  development  of  the  future  Eudamed  database  would  become  too  complex  and 
would not meet the needs of the national competent authorities, the notified bodies, 
economic operators and the public at large.  

The IT infrastructure would not support the registration of all medical devices placed 
on  the  EU  market  (several  hundreds  of  thousands),  or  the  reporting  of  serious 
incidents and field safety corrective actions (several thousands a years), the reporting 
of market surveillance measures, or the single submission of applications for clinical 
investigations and the reporting of related serious adverse events.  

The  non-public  parts  of  the  Eudamed  database  with  sensitive  personal  and 
commercial information would disclose confidential information, e.g. due to hacking 
or software failure.  

Risks related to the conformity assessment of medical devices: 

By the date of application of the new Regulations, an insufficient number of notified 
bodies would be designated in accordance with the new requirements which would 
lead to a delay for manufacturers to get their devices approved. 

The  scrutiny  mechanism  would  be  used  in  a  way  that  would  delay,  in  a 
disproportionate manner, access to market of innovative medical devices. 

The  IT  tool  for  the  notification  of  information  regarding  new  applications  and/or 
submission  of  preliminary  assessments  by  notified  bodies,  which  contains 

EN 

182 

   EN 

 
commercially  sensitive  information,  would  disclose  confidential  information,  e.g. 
due to hacking or software failure. 

2.2.2.  Control method(s) envisaged  

Control methods regarding risks related to Eudamed:  

The development of Eudamed is given high priority with a high level of sensitivity as 
regards its functioning.  

Close  and  regular  contacts  between  the  Commission  services  responsible  for  the 
management of the regulatory framework and the IT developers. 

Close and regular contacts between the Commission services/IT developers and the 
future users of the IT infrastructure.  

Control  methods  regarding  risks  related  to  the  conformity  assessment  of  medical 
devices:  

The  reinforced  and  coordinated  supervision  of  notified  bodies  in  the  context  of  the 
'immediate action' initiated after the PIP scandal already takes account of the future 
requirements laid down in the proposal and thus supports a smooth transition.  

The  Commission  shall  create  guidance  to  ensure  a  proportionate  and  workable 
operation of the new scrutiny mechanism.  

The development of the IT tool is given high priority with a high level of sensitivity 
as regards its functioning. 

2.3.  Measures to prevent fraud and irregularities  

Specify existing or envisaged prevention and protection measures. 

In  addition  to  the  application  of  all  regulatory  control  mechanisms,  the  responsible 
Commission's  services  will  devise  an  anti-fraud  strategy  in  line  with  the 
Commission's new anti-fraud strategy (CAFS) adopted on 24 June 2011 in order to 
ensure inter alia that its internal anti-fraud related controls are fully aligned with the 
CASF  and  that  its  fraud  risk  management  approach  is  geared  to  identify  fraud  risk 
areas and adequate responses. Where necessary, networking groups and adequate IT 
tools  dedicated  to  analysing  fraud  cases  related  to  the  financing  implementing 
activities of the Medical Devices Regulations will be set up. In particular a series of 
measures will be put in place such as:  

-  decisions,  agreements  and  contracts  resulting  from  the  financing  implementing 
activities of the Medical Devices Regulations will expressly entitle the Commission, 
including OLAF, and the Court of Auditors to conduct audits, on-the-spot checks and 
inspections; 

-  during  the  evaluation  phase  of  a  call  for  proposals/tender,  the  proposers  and 
tenderers are checked against the published exclusion criteria based on declarations 
and the Early Warning System (EWS);  

EN 

183 

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- the rules governing the eligibility of costs will be simplified in accordance with the 
provisions of the Financial Regulation; 

-  regular  training  on  issues  related  to  fraud  and  irregularities  is  given  to  all  staff 
involved  in  contract  management  as  well  as  to  auditors  and  controllers  who  verify 
the beneficiaries' declarations on the spot. 

Moreover, the Commission will control a strict application of the rules on conflict of 
interests provided in the proposal.  

EN 

184 

   EN 

 
3. 

3.1. 

ESTIMATED FINANCIAL IMPACT OF THE PROPOSAL/INITIATIVE  

Heading(s)  of  the  multiannual  financial  framework  and  expenditure  budget 
line(s) affected  

•  Existing expenditure budget lines  

In order of multiannual financial framework headings and budget lines. 

Operational resources which are necessary for implementation of this initiative 
will  be  covered  by  the  allocations  proposed  under  the  Health  for  Growth 
Programme 2014-2020. 

Budget line 

Type of  
expenditure

Contribution  

Number  
[Description: Health for Growth Programme] 

Diff./non-
diff. 
(68) 

from 
EFTA69 
countries 

from 
candidate 
countries70 

from third 
countries 

within the 
meaning of Article 
18(1)(aa) of the 
Financial 
Regulation  

Heading of 
multiannual 
financial 
framework 

17.03.XX. 

3 

Diff/non-
diff. 

YES/NO 

YES/NO 

(to 
be 
determined 
whether 
Turkey – in 
the  context 
of 
the 
Customs 
Union  and 
as 
candidate 
country  – 
should 
contribute.)  

YES/NO 

YES/NO 

68 
69 
70 

Diff. = Differentiated appropriations / Non-diff. = Non-Differentiated Appropriations 
EFTA: European Free Trade Association.  
Candidate countries and, where applicable, potential candidate countries from the Western Balkans. 

EN 

185 

   EN 

 
 
                                                 
3.2. 

3.2.1. 

Estimated impact on expenditure  

Summary of estimated impact on expenditure (in current prices) 

Heading of multiannual financial 
framework:  

Number 

3 

Citizenship (Health for Growth Programme) 

EUR million (to 3 decimal places) 

DG SANCO 

(cid:121) Operational appropriations71  

Number of budget line: 17.03.XX72 

of 

administrative 
Appropriations 
 from the envelope for specific programmes73  
Number of budget line:  

an 

TOTAL appropriations 
for DG SANCO 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

2019 et sq years 

TOTAL 

Commitments 

Payments 

(1) 

(2) 

5,296 

5,677 

6,667 

7,662 

7,590 

7,742 

2,648 

5,486 

6,172 

7,165 

7,626 

7,666 

7,742 
7,742 
+ 3,871 

48,376 

48,376 

nature 

financed 

Commitments 

(3) 

=1+1a 
+3 

5,296 

5,677 

6,667 

7,662 

7,590 

7,742 

7,742 

Payments 

=2+2a 

2,648 

5,486 

6,172 

7,165 

7,626 

7,666 

7,742 
+ 3,871 

48,376 

48,376 

71 
72 

73 

EN 

Costs for development of IT and for technical/scientific support.  
The cost of the action will be entirely covered by the envelope of the Health for Growth programme under the budgetary line related to the relevant objective of the 
programme. 
Technical and/or administrative assistance and expenditure in support of the implementation of EU programmes and/or actions (former "BA" lines), indirect research, 
direct research. 

186 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

+3 

(4) 

(5) 

(6) 

5,296 

5,677 

6,667 

7,662 

7,590 

7,742 

2,648 

5,486 

6,172 

7,165 

7,626 

7,666 

7,742 
7,742 
+ 3,871 

48,376 

48,376 

TOTAL appropriations  
under HEADING 3B 
of the multiannual financial 
framework 

Commitments 

=4+ 6 

5,296 

5,677 

6,667 

7,662 

7,590 

7,742 

7,742 

48,376 

Payments 

=5+ 6 

2,648 

5,486 

6,172 

7,165 

7,626 

7,666 

7,742 
+ 3,871 

48,376 

If more than one heading is affected by the proposal / initiative: 

(cid:121) TOTAL operational appropriations  

Commitments 

Payments 

(cid:121)  TOTAL  appropriations  of  an  administrative  nature 
financed from the envelope for specific programmes  

(4) 

(5) 

(6) 

TOTAL appropriations  
under HEADINGS 1 to 4 
of the multiannual financial 
framework 
(Reference amount) 

Commitments 

=4+ 6 

Payments 

=5+ 6 

EN 

187 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Heading of multiannual financial 
framework:  

5 

" Administrative expenditure " 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

2019 et sq years 

TOTAL 

EUR million (to 3 decimal places) 

DG SANCO 

(cid:121) Human resources  
(cid:121) Other administrative expenditure  

2,413 

0,469 

2,413 

0,478 

2,413 

0,488 

2,413 

0,497 

2,413 

0,508 

2,413 

0,519 

2,413 

0,519 

TOTAL DG SANCO 

Appropriations  

2,882 

2,891 

2,901 

2,910 

2,921 

2,932 

2,932 

16,891 

3,478 

20,369 

TOTAL appropriations 
under HEADING 5 
of the multiannual financial 
framework  

(Total 
= Total payments) 

commitments 

2,882 

2,891 

2,901 

2,910 

2,921 

2,932 

2,932 

20,369 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

2019 et sq years 

TOTAL 

EUR million (to 3 decimal places) 

TOTAL appropriations  
under HEADINGS 1 to 5 
of the multiannual financial 
framework  

Commitments 

8,178 

8,568 

9,568 

10,572 

10,511 

10,674 

10,674 

68,745 

Payments 

5,530 

8,377 

9,073 

10,075 

10,547 

10,598 

10,674
+ 3,871 

68,745 

EN 

188 

EN 

 
  
 
 
 
 
 
 
 
 
3.2.2.  Estimated impact on operational appropriations  

–  (cid:133)  The proposal/initiative does not require the use of operational appropriations  

–  X  The proposal/initiative requires the use of operational appropriations, as explained below: 

Indicate 
objectives 
and 
outputs  

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

2019 et sq years 

TOTAL 

OUTPUTS 

Type of 
output74 

(cid:216) 

Avera
ge 
cost  
of the 
output 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

r
e
b
m
u
N

s
t
u
p
t
u
o

f
o

Cost 

Total 
numbe
r of 
output
s 

Total  
cost 

Commitment appropriations in EUR million (to 3 decimal places) 

SPECIFIC OBJECTIVE No 1  

- Output  Meetings 

of 

MDCG 

- Output 

Technical  and 
scientific 
opinions  and 
advice 

Establish  mechanisms  to  ensure  harmonised  implementation  of  the  rules  by  all  Member  States  with  a  sustainable,  efficient  and 
credible management at EU level with access to internal and external technical, scientific and clinical expertise, allowing improved 
coordination and resource-sharing between Member States 

80 
meet
ing 
days 

1,873 

1,910 

80 
meet
ing 
days

1,948 

80 
meeting 
days 

80 
meeting 
days 

1,987 

80 
me
eti
ng 
da
ys

2,027 

2,068

2,068 

80 
meeti
ng 
days

80 
meeti
ng 
days

13,881 

0,406 

0,690 

1,580 

2,473 

2,523 

2,573

2,573 

12,818 

74 

Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.). 

EN 

189 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
- Output 

Audits  /  'joint 
assessments' 
of  80  notified 
bodies 

0,416 

0,424 

0,433 

0,442 

0,450 

0,459

0,459 

3,083 

Sub-total for specific objective N°1 

2,695 

3,024 

3,961 

4,902 

5,000 

5,100

5100 

29,782 

SPECIFIC OBJECTIVE No 2 

Enhance transparency regarding medical devices on the EU market, including their traceability 

1 

2,081 

1 

2,122 

1 

2,165 

1 

2,208 

1 

2,027 

1 

2,068

1 

2,068 

14,739 

- Output 

6 

inv., 

Eudamed 
(with 
electronic 
systems:  UDI, 
registration, 
certificates, 
clinical 
vigilance, 
market  surv.), 
as  of  2018 
with  statistical 
analysis 
/ 
business 
intelligence) 
for 
detection 

signal 

- Output 

Translations, 
info 
campaigns, 
publications 
etc.  

tbd 

0,520 

tbd 

0,531 

tbd 

0,541 

tbd 

0,552 

0,563 

tbd 

0,574

tbd 

0,574 

3,855 

tb
d 

Sub-total for specific objective N°2 

2,601 

2,653 

2,706 

2,760 

2,590 

2,642

2,642 

18,594 

Total costs 

5,296 

5,677 

6,667 

7,662 

7,590 

7,742 

7,742 

48,376 

EN 

190 

EN 

 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.2.3.  Estimated impact on appropriations of an administrative nature 

3.2.3.1.  Summary  

–  (cid:133)  The  proposal/initiative  does  not 

require 

the  use  of  administrative 

appropriations  

–  X  The  proposal/initiative  requires  the  use  of  administrative  appropriations,  as 

explained below: 

EUR million (to 3 decimal places) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

2019 et sq years 

TOTAL 

HEADING 5 
of the multiannual 
financial framework 

Human resources  

2,413 

2,413 

2,413

2,413

2,413

2,413 

2,413

16,891 

0,469 

0,478 

0,488 

0,497 

0,508 

0,519 

0,519 

3,478 

2,882 

2,891 

2,901 

2,910 

2,921 

2,932 

2,932 

20,369 

Other  administrative 
expenditure  

Subtotal HEADING 5 
of the multiannual 
financial framework  

Outside HEADING 575 
of the multiannual 
financial framework  

Human resources  

Other 
expenditure  
of  an  administrative 
nature 

Subtotal  
outside HEADING 5 
of the multiannual 
financial framework  

TOTAL 

2,882 

2,891 

2,901 

2,910 

2,921 

2,932 

2,932 

20,369

75 

Technical  and/or  administrative  assistance  and  expenditure  in  support  of  the  implementation  of  EU 
programmes and/or actions (former "BA" lines), indirect research, direct research. 

EN 

191 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.2.3.2.   Estimated requirements of human resources  

–  (cid:133)  The proposal/initiative does not require the use of human resources  

–  X  The  proposal/initiative  requires  the  use  of  human  resources,  as  explained 

below: 

Estimate to be expressed in full amounts (or at most to one decimal place) 

Year 
2014 

Year 
2015 

Year 
2016 

Year 
2017 

Year 
2018 

Year 
2019 

Year 
>2019 

(cid:121) Establishment plan posts (officials and temporary agents) 

17 01 01 01 (Headquarters and Commission’s 
Representation Offices) 

19 

19 

19 

19 

19 

19 

19 

XX 01 01 02 (Delegations) 

XX 01 05 01 (Indirect research) 

10 01 05 01 (Direct research) 

(cid:121) External personnel (in Full Time Equivalent unit: FTE)76 

XX 01 02 01 (CA, INT, SNE from the "global 
envelope") 

XX 01 02 02 (CA, INT, JED, LA and SNE in 
the delegations) 

XX 01 04 yy 77 

- at Headquarters78 

- in delegations  

XX 01 05 02 (CA, INT, SNE - Indirect 
research) 

10 01 05 02 (CA, INT, SNE - Direct research) 

Other budget lines (specify) 

TOTAL 

19 

19 

19 

19 

19 

19 

19 

XX is the policy area or budget title concerned. 

The human resources required will be met by staff from DG SANCO who are already 
assigned  to  the  management  of  the  action  and  who  will  be  redeployed  within  DG 
SANCO, together if necessary with any additional allocation which may be granted to 
the managing DG under the annual allocation procedure and in the light of budgetary 
constraints (estimated needs: 16 AD/FTE and 3 AST/FTE). 

Description of tasks to be carried out: 

Officials and temporary agents 

implementation  of 

Control  of  appropriate 
this  Regulation;  development  of 
delegated/implementing acts and guidance; development of new electronic systems for 
Eudamed  (in  cooperation  with  IT  staff);  organisation  and  direction  of  'joint 
assessments' of notified bodies and control of designation and monitoring process by 
Member  States;  coordination  of  market  surveillance  activities  with  EU  wide  impact; 

76 

77 
78 

CA= Contract Agent; INT= agency staff ("Intérimaire"); JED= "Jeune Expert en Délégation" (Young 
Experts in Delegations); LA= Local Agent; SNE= Seconded National Expert;  
Under the ceiling for external personnel from operational appropriations (former "BA" lines). 
Essentially  for  Structural  Funds,  European  Agricultural  Fund  for  Rural  Development  (EAFRD)  and 
European Fisheries Fund (EFF). 

EN 

192 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
follow-up  of  national  safeguard  and  preventive  health  protection  measures; 
international  regulatory  cooperation;  management  of  Medical  Device  Committee 
(committee within the meaning of Reg. 182/2011). 

External personnel 

3.2.4.  Compatibility with the current multiannual financial framework  

–  X  Proposal/initiative is compatible with the new multiannual financial framework 

2014-2020. 

–  (cid:133)  Proposal/initiative  will  entail  reprogramming  of  the  relevant  heading  in  the 

multiannual financial framework. 

Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 

–  (cid:133)  Proposal/initiative requires application of the flexibility instrument or revision 

of the multiannual financial framework79. 

Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 

3.2.5.  Third-party contributions  

–  The proposal/initiative does not provide for co-financing by third parties  

–  The proposal/initiative provides for the co-financing estimated below: 

Appropriations in EUR million (to 3 decimal places) 

Year 
N 

Year 
N+1 

Year 
N+2 

Year 
N+3 

… enter as many years as 
necessary to show the duration 
of the impact (see point 1.6) 

Total 

Specify  the  co-financing 
body  

TOTAL 
cofinanced  

appropriations 

79 

See points 19 and 24 of the Interinstitutional Agreement. 

EN 

193 

   EN 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
3.3. 

Estimated impact on revenue  

–  (cid:133)  Proposal/initiative has no financial impact on revenue. 

–  (cid:133)  Proposal/initiative has the following financial impact: 

–  1.  on own resources 

–  2.  on miscellaneous revenue 

Budget revenue line: 

Appropriation
s available for 
the ongoing 
budget year 

EUR million (to 3 decimal places) 

Impact of the proposal/initiative80 

2014 

2015 

2016 

2017 

Subsequent years 

Article …………. 

0 

0 

0 

0 

0 

0 

0 

For miscellaneous assigned revenue, specify the budget expenditure line(s) affected. 

Specify the method for calculating the impact on revenue. 

80 

As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 25% for collection costs. 

EN 

194 

   EN