Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices
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) 541 final 

2012/0267 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on in vitro diagnostic medical devices  

(Text with EEA relevance) 

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

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EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

The current EU regulatory framework for in vitro diagnostic medical devices ('IVDs') consists 
of Directive 98/79/EC of the European Parliament and of the Council ('the IVD Directive')1 
IVDs cover  a  wide range  of  products  that can be  used for population screening and disease 
prevention,  diagnosis,  monitoring  of  prescribed  treatments  and  assessment  of  medical 
interventions. 
Like  Council  Directive  90/385/EEC  on  active  implantable  medical  devices  (AIMDD)2  and 
Council Directive 93/42/EEC on medical devices (MDD)3 the IVD Directive is based on the 
'New Approach' and aims to ensure the smooth functioning of the internal market and a high 
level  of  protection  of  human  health  and  safety.  IVDs  are  not  subject  to  any  pre-market 
authorisation by a regulatory authority but to a conformity assessment which, for the majority 
of devices, is carried out under the sole responsibility of the manufacturer. For the high-risk 
devices listed in Annex II and devices for self-testing, the conformity assessment involves an 
independent  third  party,  known  as  'notified  body'.  Notified  bodies  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 for in vitro diagnostic medical devices has demonstrated 
its merits but has also come under criticism in recent years.  
In  an  internal  market  with  32  participating  countries4  and  subject  to  constant  scientific  and 
technological  progress,  substantial  divergences  in  the  interpretation  and  application  of  the 
rules have emerged, thus undermining the main objectives of the Directive, i.e. the safety and 
performance of IVDs and their free movement.  

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

This  proposal  is  adopted  alongside  a  proposal  for  a  Regulation  on  medical  devices  that  are 
currently covered by the AIMDD and the MDD. While the specific features of IVDs and of 
the  IVD  sector  require  the  adoption  of  a  specific  legislation  distinct  from  the  legislation  on 
other medical devices, the horizontal aspects common to both sectors have been aligned. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENTS 

In preparation for the impact assessment on this proposal and the proposal for a Regulation on 
medical devices, 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 

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4 

OJ L 331, 7.12.1998, p. 1. 
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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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 IVD Directive 
and showed wide support for this initiative. 

During  2009,  2010  and  2011,  the  issues  to  be  tackled  in  the  revision  of  the  regulatory 
framework  for  medical  devices  and  in  vitro  diagnostic  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 in vitro 
diagnostic  medical  devices  (IVDs),  notified  bodies,  borderline  and  classification,  clinical 
investigation  and  evaluation,  vigilance  and  market  surveillance,  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  into 
account, where appropriate, for the further development of the proposals.  

In  addition,  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.  

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.  

5 
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7 

See http://ec.europa.eu/health/medical-devices/documents/revision/index_en.htm. 
OJ L 247, 21.9.2007, p. 21. 
OJ C 202, 8.7.2011, p. 7. 

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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. 

3.1. 

LEGAL ELEMENTS OF THE PROPOSAL 

Scope and definitions (Chapter I) 

To  a  large  extent,  the  scope  of  the  proposed  Regulation  matches  the  scope  of  Directive 
98/79/EC, i.e. it covers in vitro diagnostic medical devices. The proposed changes clarify and 
extend the scope of the IVD Directive. They concern:  

• 

• 

• 

high-risk devices manufactured and used within a single health institution, which are 
subject to most of the requirements set out in the proposal;  

tests  providing  information  about  the  predisposition  to  a  medical  condition  or  a 
disease  (e.g.  genetic  tests)  and  tests  providing  information  to  predict  treatment 
response or reactions (e.g. companion diagnostics), which are considered as in vitro 
diagnostic medical devices ; 

medical software, which is explicitly mentioned in the definition of IVDs. 

To  support  Member  States  and  the  Commission  in  determining  the  regulatory  status  of 
products,  the  Commission  may  set  up,  in  accordance  with  its  internal  rules9,  a  group  of 
experts  from  various  sectors  (such  as  IVDs,  medical  devices,  medicinal  products,  human 
tissues and cells, cosmetics and biocides).  

The definitions section has been significantly extended, aligning the definitions in the field of 
in vitro diagnostic medical devices with well-established European and international practice, 
such  as  the  New  Legislative  Framework  for  the  Marketing  of  Products10  and  guidance 
documents  produced  for  in  vitro  diagnostic  medical  devices  by  the  Global  Harmonization 
Task-Force (GHTF)11

 . 

3.2.  Making  available  of  devices,  obligations  of  economic  operators,  CE  marking, 

free movement (Chapter II) 

This  chapter  covers  mainly  horizontal  issues  similar  for  both  medical  devices  and  IVDs.  It 
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).  It  also  provides  clarification  with 
regard  to  the  adoption  and  the  scope  of  common  technical  specifications  (CTS)  for  in  vitro 
diagnostic medical devices.  

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 

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of 

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2012 

(2012/2621(RSP)); 

P7_TA-PROV(2012)0262, 

Resolution 
http://www.europarl.europa.eu/plenary/en/texts-adopted.html   
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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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.  

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  the  devices  placed  on  the  market.  Their  minimum  contents  are  laid  down  in 
Annexes II and III.  

The following concepts are new in the field of IVDs:  

• 

• 

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 Directive on medical devices in some Member States.  

Since  in  the  case  of  'parallel  trade'  with  in  vitro  diagnostic  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 IVDs. 

3.3. 

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

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

• 

• 

• 

• 

• 

a  requirement  that  economic  operators  shall  be  able  to  identify  who  supplied  them 
and to whom they have supplied IVDs; 

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  shall 
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/EU12,  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 
performance  studies,  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.  

12 

OJ L 102, 23.4.2010, p. 45. 

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3.4. 

Notified bodies (Chapter IV) 

Proper functioning of notified bodies is crucial for ensuring a high level of health and safety 
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  assessment 
performed by them.  

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 IVDs 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) 

Annex II to the IVD Directive addresses the level of risk posed by IVD medical devices by 
means of a positive list system. While this system was adapted to scientific and technological 
development at the time the IVD Directive was written, today it can no longer keep up with 
the fast pace of scientific and technological progress. The proposal introduces a new risk-rule 
based classification system, built on GHTF principles, which replaces the current list of IVD 
medical devices in Annex II to Directive 98/79/EC.  

In  the  new  classification  system,  IVDs  will  be  divided  into  four  classes  of  risk:  A  (lowest 
risk), B, C and D (highest risk). The conformity assessment procedures have been adapted to 
match  each  of  these  four  device  classes,  using  the  existing  modules  established  under  the 
'New Approach'. The conformity assessment procedure for class A devices will 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 A devices are intended for 
near-patient testing, have a measuring function or are sold sterile, a notified body shall verify 
respectively  the  aspects  related  to  design,  the  measuring  function  or  to  the  sterilisation 
process. For devices of classes B, C and D an appropriate level of involvement of a notified 
body is compulsory proportionate to the risk class, with devices of class D 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 B and C devices, the notified 
body checks the quality management system and, for class C, the technical documentation of 
representative  samples.  After  initial  certification,  notified  bodies  shall  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 

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have  been  tightened  and  streamlined.  One  conformity  assessment  procedure  provided  for 
under  the  IVD  Directive  (EC  verification)  has  been  deleted  as  the  responses  to  the  public 
consultation  highlighted  that  it  was  under-used.  The  concept  of  batch  testing  has  been 
clarified.  The  proposal  reinforces  the  powers  and  responsibilities  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  devices  for  performance 
evaluation continue to be subject to specific provisions.  

In  addition,  the  proposal  introduces  the  obligation  for  notified  bodies  to  notify  an  expert 
committee  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 days13, 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/EC14). Its use should be the exception rather than the rule and 
should follow clear and transparent criteria.  

3.6. 

Clinical evidence (Chapter VI) 

The proposal spells out the requirements for clinical evidence for in vitro diagnostic medical 
devices which are proportionate to the risk class. The key obligations are set out in Chapter VI 
while more detailed provisions are laid down in Annex XII. 

While  most  clinical  performance  studies  follow  an  observational  design  and  therefore  the 
results obtained are not used for patient management and do not impact treatment decisions, 
specific  requirements  have  been  introduced  in  Annex  XIII  for  the  conduct  of  interventional 
clinical performance studies and other clinical performance studies where the conduct of the 
study,  including  specimen  collection,  involves  invasive  procedures  or  other  risks  for  the 
subjects of the studies.  

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/EC15.  

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

In  accordance  with  recognised  international  ethical  principles,  every  interventional  clinical 
performance study and other clinical performance study involving risks for the subjects of the 

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15 

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  a  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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study shall 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 
interventional  clinical  performance  studies  and  other  clinical 
performance  studies  involving  risks  for  the  subjects  of  the  studies  should  be  interoperable 
with the future EU database to be set up in accordance with the future Regulation on clinical 
trials on medicinal products for human use. 

Before  commencing  an  interventional  clinical  performance  study  or  any  other  clinical 
performance study involving risks  for  the  subjects of the study, the  sponsor  shall  submit an 
application  to  confirm  that  there  are  no  health  and  safety  aspects  or  ethical  aspects  which 
would oppose it. A new possibility will be opened up for sponsors of an interventional clinical 
performance study or any other clinical performance study involving risks for the subjects of 
the study to be conducted in more than one Member State: in future they may, if they wish, 
submit a single application through the electronic system to be set up by the Commission. As 
a  consequence,  the  health  and  safety-related  aspects  regarding  the  device  for  performance 
evaluation  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 clinical performance studies 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  performance 
study  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 
interventional clinical performance studies or any other clinical performance study involving 
risks  for  the  subjects  of  the  study.  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 
because complications with devices may 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 shall report serious incidents and corrective actions they have taken to 
reduce  the  risk  of  recurrence.  The  information  will  be  automatically  made  available  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  fields  of  medical 
devices and in vitro diagnostic medical devices and set up by Regulation (EU) [Ref. of future 
Regulation  on  medical  devices]  on  medical  devices16.  The  MDCG  and  its  subgroups  will 
allow to build a forum for discussions with stakeholders. The proposal creates the legal basis 

16 

OJ L […], […], p. […] 

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that for specific hazards or technologies or for verifying compliance with common technical 
specifications by devices posing the highest risk, 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 option 
either  the  extension  of  the  responsibility  of  the  European  Medicines  Agency  (EMA)  to  in 
vitro diagnostic medical devices or the management of the in vitro diagnostic medical devices 
regulatory system by the Commission. Taking into account the clear preference expressed by 
stakeholders,  including  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  this  Regulation,  or  delegated  acts  to  complement  the 
regulatory framework for in vitro diagnostic medical devices over time. 

The  new  Regulation  will  become  applicable  five  years  after  its  entry  into  force  in  order  to 
take  into  account  the  significant  changes  to  the  classification  system  for  IVDs  and  to  the 
conformity  assessment  procedures.  This  will,  on  the  one  hand,  allow  time  to  set  up  a 
sufficient number of notified bodies, and, on the other hand, mitigate the economic impact on 
manufacturers. The Commission needs also 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 this 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 in vitro diagnostic medical devices on the market. Special transitional 
provisions  are  foreseen  for  the  registration  of  in  vitro  diagnostic  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 will replace and repeal Directive 98/79/EC of the European Parliament 
and of the Council.  

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.  With  the  entry  into  force  of  the  Lisbon  Treaty,  the 
legal basis 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 IVDs, 
the Union is exercising its shared power under Article 4(2) of the Treaty on the Functioning 
of the European Union.  

Under  the  current  IVD  Directive,  IVDs  that  bear  the  CE  marking  can,  in  principle,  move 
freely within the EU. The proposed revision of the existing directive, 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 90% of the IVD 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 

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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  IVD  Directive  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 performance studies, 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 in vitro diagnostic medical devices made available on 
the  Union  market.  The  proposal  affects  the  freedom  of  economic  operators  to  conduct 
business 
imposed  on  manufacturers,  authorised 
representatives, importers and distributors of in vitro diagnostic medical devices are necessary 
to guarantee a high level of safety of those products.  

(Article  16)  but 

the  obligations 

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

This  proposal  does  not  have  any  additional  direct  budgetary  implication  because  the  cost-
relevant  arrangements  are  already  covered  by  the  proposal  for  a  Regulation  on  medical 
devices.  The  financial  statement  of  that  proposal  lists  the  details  of  the  costs  related  to  the 
implementation  of  both  Regulations.  A  thorough  discussion  on  the  costs  is  contained  in  the 
impact assessment report. 

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2012/0267 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on in vitro diagnostic medical devices  

(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 Committee17, 
Having regard to the opinion of the Committee of the Regions18, 
After consulting the European Data Protection Supervisor19, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 
on  in  vitro  diagnostic  medical  devices20  constitutes  the  Union  regulatory  framework 
for  in  vitro  diagnostic  medical  devices.  However,  a  fundamental  revision  of  that 
Directive  is  needed  to  establish  a  robust,  transparent,  predictable  and  sustainable 
regulatory  framework  for  devices  which  ensures  a  high  level  of  safety  and  health 
whilst supporting innovation.  

This  Regulation  aims  to  ensure  the  functioning  of  the  internal  market  as  regards  in 
vitro diagnostic 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 devices 
to meet common safety concerns as regards those products. Both objectives are being 
pursued simultaneously and are inseparably linked whilst one not being secondary to 
the  other.  As  regards  Article  114  of  the  Treaty  on  the  Functioning  of  the  European 
Union, this Regulation harmonises the rules for the placing on the market and putting 
into service of in vitro diagnostic 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) of the Treaty on the Functioning of the European Union, this 
Regulation  sets  high  standards  of  quality  and  safety  for  those  devices  by  ensuring, 
among other things, that data generated in clinical performance studies is reliable and 

17 
18 
19 
20 

OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ C […], […], p. […]. 
OJ L 331, 7.12.1998, p.1 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

robust  and  that  the  safety  of  subjects  participating  in  clinical  performance  studies  is 
protected. 

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

To the extent possible, guidance developed for in vitro diagnostic 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  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 evidence. 

There are specific features of in vitro diagnostic medical devices, in particular in terms 
of risk classification, conformity assessment procedures and clinical evidence, and of 
the in vitro diagnostic medical device sector which require the adoption of a specific 
legislation,  distinct  from  the  legislation  on  other  medical  devices,  whereas  the 
horizontal aspects common to both sectors should be aligned. 

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 
legislation  concerning  products  such  as  medical  devices,  general  laboratory  products 
and products for research use only. 

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 an in vitro diagnostic medical device or of an accessory to an in vitro 
diagnostic medical device.  

(9) 

(10) 

To ensure the highest level of health protection, the rules governing in vitro diagnostic 
medical  devices  manufactured  and  used,  including  measurement  and  delivery  of 
results, only within a single health institution should be clarified and strengthened. 

It  should  be  clarified  that  software  specifically  intended  by  the  manufacturer  to  be 
used  for  one  or  more  of  the  medical  purposes  set  out  in  the  definition  of  an  in  vitro 
diagnostic medical device is qualified as an in vitro diagnostic medical device, while 
software  for  general  purposes,  even  when  used  in  a  healthcare  setting,  or  software 
intended for well-being applications is not qualified as an in vitro diagnostic medical 
device. 

(11) 

It should be made clear that all tests that provide information on the predisposition to a 
medical condition or a disease (e.g. genetic tests) and tests that provide information to 
predict  treatment  response  or  reactions,  such  as  companion  diagnostics,  are  in  vitro 
diagnostic medical devices. 

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12 

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(12)  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/EEC21  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/EC22  are  an 
integral part of the general safety and performance requirements for in vitro diagnostic 
medical devices. Consequently, this Regulation should be considered a lex specialis in 
relation to those Directives. 

(13)  This Regulation should include requirements regarding the design and manufacture of 
in  vitro  diagnostic  medical  devices  emitting  ionising  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  radiation23,  nor  of  Council  Directive 
97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers 
of  ionising  radiation  in  relation  to  medical  exposure  and  repealing  Directive 
84/466/Euratom24 which pursue other objectives.  

(14) 

(15) 

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  Area25,  the  Agreement  between  the  European  Community  and  the  Swiss 
Confederation  on  mutual  recognition  in  relation  to  conformity  assessment26  and  the 
Agreement  of  12  September  1963  establishing  an  association  between  the  European 
Economic Community and Turkey27. 

It should be made clear that in vitro diagnostic 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 
regulations28 as well as devices used in the context of a commercial activity to provide 
a diagnostic or 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. 

(16)  To  recognise  the  important  role  of  standardisation  in  the  field  of  in  vitro  diagnostic 
medical devices, compliance with harmonised standards as defined in Regulation (EU) 
No  [Ref.  of  future  Regulation  on  European  standardisation]  on  European 
standardisation29 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. 

21 
22 
23 
24 
25 
26 
27 
28 

29 

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. 
OJ C […], […], p. […]. 

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

(18)  The  rules  applicable  to  in  vitro  diagnostic  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 
339/9330  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/EEC31. 

(19)  The  rules  on  Union  market  surveillance  and  control  of  products  entering  the  Union 
market  provided  for  in  Regulation  (EC)  No  765/2008  apply  to  in  vitro  diagnostic 
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. 

(20) 

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

(21)  To ensure that in vitro diagnostic 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  in  vitro  diagnostic  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 in vitro diagnostic medical device. 

(22) 

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

(23)  For manufacturers who are not established in the Union, the authorised representative 
plays  a  pivotal  role  in  ensuring  the  compliance  of  the  in  vitro  diagnostic  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 

30 
31 

OJ L 218, 13.8.2008, p.30. 
OJ L 218, 13.8.2008, p. 82. 

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14 

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but,  with  a  view  to  the  authorised  representative's  tasks,  could  also  be  satisfied  by  a 
person with qualification in law.  

(24)  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 an in vitro diagnostic medical device. 

(25)  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 of the Treaty on the Functioning of the 
European  Union  subject  to  the  limitations  set  by  the  protection  of  health  and  safety 
and  by  the  protection  of  intellectual  property  rights  provided  by  Article  36  of  the 
Treaty  on  the  Functioning  of  the  European  Union.  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 
Justice32  in  other  relevant  sectors  and  existing  good  practices  in  the  field  of  in  vitro 
diagnostic medical devices. 

(26) 

In vitro diagnostic 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. 

(27)  The traceability of in vitro diagnostic 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  in  vitro  diagnostic  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. 

(28)  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. 

(29)  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  in  vitro  diagnostic  medical  devices  on  the  market  and  the 
relevant  economic  operators,  certificates,  interventional  clinical  performance  studies 
and other clinical performance studies involving risks for the subjects of the studies, 
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) by further developing the databank set up by 

32 

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

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Commission  Decision 2010/227/EU of 19 April 2010 on the European Databank for 
Medical Devices33. 

(30)  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  performance  studies 
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. 

(31) 

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 data34 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 data35, 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. 

(32)  For high-risk in vitro diagnostic 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. 

(33)  The proper functioning of notified bodies is crucial for ensuring a high level of health 
and  safety  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. 

(34)  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  in  vitro  diagnostic  medical  devices  to  ensure 
continuous compliance by manufacturers after receipt of the original certification. 

(35)  For high risk in vitro diagnostic 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  devices  for  which  no  common 
technical specifications exist, devices which are novel or for which a novel 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 

33 
34 
35 

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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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  in  vitro  diagnostic 
medical device before submitting the application to the notified body. 

(36)  To enhance patient safety and to take due account of technological progress, the risk 
classification  system  for  in  vitro  diagnostic  medical  devices  set  out  in  Directive 
98/79/EC should be fundamentally changed, in line with international practice, and the 
corresponding conformity assessment procedures should be accordingly adapted. 

(37) 

It is necessary, in particular for the purpose of the conformity assessment procedures, 
to classify in vitro diagnostic medical devices into four risk classes and to establish a 
set of robust risk-based classification rules, in line with international practice. 

(38)  The conformity assessment procedure for class A in vitro diagnostic medical devices 
should  be  carried  out,  as  a  general  rule,  under  the  sole  responsibility  of  the 
manufacturers, since such devices pose a low risk to patients. For in vitro diagnostic 
medical devices in classes B, C and D, the involvement of a notified body should be 
compulsory to the appropriate degree. 

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

(40) 

It is necessary to clarify the requirements regarding batch release verification for the 
highest risk in vitro diagnostic medical devices.  

(41)  European Union reference laboratories should be enabled to verify compliance of such 
devices  with  the  applicable  common  technical  specifications,  when  such  common 
technical  specifications  are  available,  or  with  other  solutions  chosen  by  the 
manufacturer to ensure a level of safety and performance that is at least equivalent. 

(42)  To ensure a high level of safety and performance, demonstration of compliance with 
the general safety and performance requirements should be based on clinical evidence. 
It is necessary to clarify the requirements for such clinical evidence. As a general rule, 
clinical evidence should be sourced from clinical performance studies 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 performance study. 

(43)  The  rules  on  clinical  performance  studies  should  be  in  line  with  major  international 
guidance, 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 
performance studies conducted in the Union are accepted elsewhere and that clinical 
performance  studies  conducted  outside  the  Union  in  accordance  with  international 
guidelines can be accepted under this Regulation. 

(44)  An  electronic  system  should  be  set  up  at  Union  level  to  ensure  that  every 
interventional  clinical  performance  studies  and  other  clinical  performance  studies 
involving  risks  for  the  subjects  of  the  studies  are  registered  in  a  publicly  accessible 
database. To protect the right to 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  performance  studies  should  be  recorded  in  the 

EN 

17 

   EN 

 
electronic  system.  To  ensure  synergies  with  the  area  of  clinical  trials  on  medicinal 
products, the electronic system on clinical performance studies on in vitro diagnostic 
medical devices should be interoperable with the EU database to be set up for clinical 
trials on medicinal products for human use.  

(45)  Sponsors of interventional clinical performance studies and other clinical performance 
studies involving risks for the subjects 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  device  for 
performance evaluation and of the scientific design of the clinical performance study 
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  performance  study, 
including 
the  ultimate 
responsibility for deciding whether the clinical performance study may be conducted 
on its territory. 

informed  consent.  Each  Member  State  should  retain 

(46)  Sponsors should report certain adverse events occurring during interventional clinical 
performance  studies  and  other  clinical  performance  studies  involving  risks  for  the 
subjects  to  the  Member  States  concerned  which  should  have  the  possibility  to 
terminate  or  suspend  these  studies  if  considered  necessary  to  ensure  a  high  level  of 
protection  of  the  subjects  enrolled  in  such  studies.  Such  information  should  be 
communicated to the other Member States. 

(47)  This  Regulation  should  only  cover  clinical  performance  studies  which  pursue 

regulatory purposes laid down in this Regulation. 

(48) 

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

(49)  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. 

(50)  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. 

(51)  The  reporting  of  serious  adverse  events  during  interventional  clinical  performance 
studies and other clinical performance studies involving risks for the subjects, and the 
reporting of serious incidents occurring after an in vitro diagnostic medical device has 
been placed on the market should be clearly distinguished to avoid double reporting. 

(52)  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. 

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(53)  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. 

(54)  Whilst this Regulation should not affect the right of the 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. 

(55)  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  in 
accordance  with  the  conditions  and  modalities  defined  in  Article  78  of  Regulation 
(EU) [Ref. of future Regulation on medical devices] on medical devices36 to fulfil the 
tasks  conferred  on  it  by  this  Regulation  and  by  Regulation  (EU)  [Ref.  of  future 
Regulation  on  medical  devices]  on  medical  devices,  to  provide  advice  to  the 
Commission  and  to  assist  the  Commission  and  the  Member  States  in  ensuring  a 
harmonised implementation of this Regulation.  

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

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

(58)  The  Union  should  actively  participate  in  international  regulatory  cooperation  in  the 
field of in vitro diagnostic medical devices to facilitate the exchange of safety-related 
information  regarding  in  vitro  diagnostic  medical  devices  and  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. 

(59)  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. 

(60) 

In  order  to  maintain  a  high  level  of  health  and  safety,  the  power  to  adopt  acts  in 
accordance with Article 290 of the Treaty on the Functioning of the European Union 
should  be  delegated  to  the  Commission  in  respect  of  the  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 
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 

36 

OJ L […], […], p. […] 

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approval  of  clinical  performance  studies;  the  establishment  of  the  UDI  system;  the 
information to be submitted for the registration of in vitro diagnostic 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 
performance  studies;  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. 

(61) 

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 powers37.  

(62)  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 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. 

(63)  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 
an  in  vitro  diagnostic  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  an  in  vitro  diagnostic  medical  device  presenting  a  risk, 
imperative grounds of urgency so require.  

(64)  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  in  vitro  diagnostic 
medical devices on the market. 

that  adaptation  and  for 

transitional  period  for 

(65) 

In order to ensure a smooth transition to the registration of in vitro diagnostic medical 
devices, of relevant economic operators and of certificates, the obligation to submit the 
relevant 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 10 and points (a) and (b) of Article 
12(1) of Directive 98/79/EC 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 

37 

OJ L 55, 28.2.2011, p. 13. 

EN 

20 

   EN 

 
                                                 
by the Member States pursuant to those provisions of the Directive to avoid multiple 
registrations. 

(66)  Directive 98/79/EC should be repealed to ensure that only one set of rules applies to 
the placing of in vitro diagnostic medical devices on the market and the related aspects 
covered by this Regulation.  

(67)  Since the objective of this Regulation, namely to ensure high standards of quality and 
safety for in vitro diagnostic 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: 

EN 

21 

   EN 

 
Chapter I 
Scope and definitions 

Article 1 

Scope 

1. 

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

For  the  purposes  of  this  Regulation,  in  vitro  diagnostic  medical  devices  and 
accessories to in vitro diagnostic medical devices shall hereinafter be referred to as 
'devices'. 

2. 

This Regulation shall not apply to:  

(a)  products  for  general  laboratory  use,  unless  such  products,  in  view  of  their 
characteristics, are specifically intended by their manufacturer to be used for in 
vitro diagnostic examination; 

(b) 

invasive  sampling  devices  or  those  which  are  directly  applied  to  the  human 
body for the purpose of obtaining a specimen; 

(c)  higher metrological order reference materials. 

Any  device  which,  when  placed  on  the  market  or  used  in  accordance  with  the 
manufacturer's  instructions,  incorporates  as  an  integral  part  a  medical  device  as 
defined  in  Article  2  of  Regulation  (EU)  [Ref.  of  future  Regulation  on  medical 
devices]  on  medical  devices  without  being  an  in  vitro  diagnostic  medical  device, 
shall be governed by this Regulation, provided that the principal intended purpose of 
the combination is that of an in vitro diagnostic medical device referred to in Article 
2(2)  of  this  Regulation.  The  relevant  general  safety  and  performance  requirements 
set out in Annex I to Regulation (EU) [Ref. of future Regulation on medical devices] 
shall apply as far as the safety and performance of the medical device part that is not 
an in vitro diagnostic medical device 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. 

3. 

4. 

5. 

6. 

7. 

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

Article 2 

Definitions 

EN 

22 

   EN 

 
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 the above-mentioned products,  

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 intended function by such means. 

'in  vitro  diagnostic  medical  device’  means  any  medical  device  which  is  a  reagent, 
reagent  product,  calibrator,  control  material,  kit,  instrument,  apparatus,  equipment, 
software  or  system,  whether  used  alone  or  in  combination,  intended  by  the 
manufacturer to be used in vitro for the examination of specimens, including blood 
and  tissue  donations,  derived  from  the  human  body,  solely  or  principally  for  the 
purpose of providing information: 

– 

– 

– 

– 

– 

– 

concerning a physiological or pathological state; 

concerning a congenital abnormality; 

concerning the predisposition to a medical condition or a disease; 

to determine the safety and compatibility with potential recipients; 

to predict treatment response or reactions; 

to define or monitor therapeutic measures. 

Specimen  receptacles  are  considered  to  be  in  vitro  diagnostic  medical  devices.  For 
the  purposes  of  this  Regulation,  ‘specimen  receptacle’  means  devices,  whether 
vacuum-type  or  not,  specifically  intended  by  their  manufacturers  for  the  primary 
containment  and  preservation  of  specimens  derived  from  the  human  body  for  the 
purpose of in vitro diagnostic examination. 

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

'device for self-testing' means any device intended by the manufacturer to be used by 
lay persons; 

'device for near-patient testing' means any device that is not intended for self-testing 
but  is  intended  to  perform  testing  outside  a  laboratory  environment,  generally  near 
to, or at the side of, the patient; 

(2) 

(3) 

(4) 

(5) 

EN 

23 

   EN 

 
(6) 

(7) 

(8) 

(9) 

(10) 

(11) 

(12) 

'companion diagnostic' means a device specifically intended to select patients with a 
previously diagnosed condition or predisposition as eligible for a targeted therapy; 

'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; 

'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. 

'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; 

'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; 

'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; 

'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; 

Definitions related to the making available of devices: 

(13) 

(14) 

(15) 

'making available on the market' means any supply of a device, other than a device 
for performance evaluation, 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;  

'placing  on  the  market'  means  the  first  making  available  of  a  device,  other  than  a 
device for performance evaluation, on the Union market;  

'putting  into  service'  means  the  stage  at  which  a  device,  other  than  a  device  for 
performance evaluation, 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: 

(16) 

'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; 

(17) 

'authorised  representative'  means  any  natural  or  legal  person  established  within  the 
Union who has received and accepted a written mandate from a manufacturer to act 
on his behalf in relation to specified tasks with regard to the latter's obligations under 
this Regulation;  

EN 

24 

   EN 

 
(18) 

(19) 

(20) 

(21) 

(22) 

(23) 

'importer' means any natural or legal person established within the Union who places 
a device from a third country on the Union market;  

'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; 

'economic  operators'  means  the  manufacturer,  the  authorised  representative,  the 
importer and the distributor; 

'health  institution'  means  an  organisation  whose  primary  purpose  is  the  care  or 
treatment of patients or the promotion of public health; 

'user' means any healthcare professional or lay person who uses a device; 

'lay  person'  means  an  individual  who  does  not  have  formal  education  in  a  relevant 
field of healthcare or medical discipline; 

Definitions related to conformity assessment: 

(24) 

(25) 

(26) 

(27) 

'conformity  assessment'  means  the  process  demonstrating  whether  the  requirements 
of this Regulation relating to a device have been fulfilled; 

'conformity  assessment  body'  means  a  body  that  performs  third-party  conformity 
assessment activities including calibration, testing, certification and inspection; 

'notified  body'  means  a  conformity  assessment  body  designated  in  accordance  with 
this Regulation; 

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

Definitions related to clinical evidence: 

(28) 

(29) 

(30) 

(31) 

(32) 

(33) 

(34) 

(35) 

'clinical  evidence'  means  the  information  that  supports  the  scientific  validity  and 
performance for the use of a device as intended by the manufacturer; 

'scientific  validity  of  an  analyte'  means  the  association  of  an  analyte  to  a  clinical 
condition or a physiological state; 

'performance  of  a  device'  means  the  ability  of  a  device  to  achieve  its  intended 
purpose  as  claimed  by  the  manufacturer.  It  consists  of  the  analytical  and,  where 
applicable, the clinical performance supporting the intended purpose of the device; 

'analytical performance' means the ability of a device to correctly detect or measure a 
particular analyte; 

'clinical performance' means the ability of a device to yield results that are correlated 
with  a  particular  clinical  condition  or  a  physiological  state  in  accordance  with  the 
target population and intended user; 

'clinical  performance  study’  means  a  study  undertaken  to  establish  or  confirm  the 
clinical performance of a device; 

'clinical performance study protocol' means the document(s) setting out the rationale, 
objectives,  design  and  proposed  analysis,  methodology,  monitoring,  conduct  and 
record-keeping of the clinical performance study; 

'performance  evaluation'  means  the  assessment  and  analysis  of  data  to  establish  or 
verify the analytical and, where applicable, the clinical performance of a device; 

EN 

25 

   EN 

 
(36) 

(37) 

(38) 

(39) 

(40) 

(41) 

(42) 

(43) 

(44) 

(45) 

(46) 

'device for performance evaluation' means a device intended by the manufacturer to 
be subject to one or more performance evaluation studies in laboratories for medical 
analyses  or  in  other  appropriate  environments  outside  the  manufacturer's  own 
premises.  Devices  intended  to  be  used  for  research  purposes,  without  any  medical 
objective, are not regarded as devices for performance evaluation; 

'interventional clinical performance study' means a clinical performance study where 
the test  results may influence  patient  management decisions and/or may be used to 
guide treatment; 

'diagnostic  specificity'  means  the  ability  of  a  device  to  recognize  the  absence  of  a 
target marker associated with a particular disease or condition; 

'diagnostic  sensitivity'  means  the  ability  of  a  device  to  identify  the  presence  of  a 
target marker associated with a particular disease or condition; 

'predictive value' means the probability that a person with a positive device test result 
has a given condition under investigation, or that a person with a negative device test 
result does not have a given condition; 

'positive  predictive  value'  means  the  ability  of  a  device  to  separate  true  positive 
results from false positive results for a given attribute in a given population; 

'negative  predictive  value'  means  the  ability  of  a  device  to  separate  true  negative 
results from false negative results for a given attribute in a given population; 

'likelihood  ratio'  means  the  likelihood  that  a  given  result  would  be  expected  in  an 
individual  with  the  target  clinical  condition  or  physiological  state  compared  to  the 
likelihood  that  the  same  result  would  be  expected  in  an  individual  without  that 
clinical condition or physiological state; 

'calibrators  and  control  materials'  means  any  substance,  material  or  article  intended 
by  the  manufacturer  either  to  establish  measurement  relationships  or  to  verify  the 
performance characteristics of a device in conjunction with the intended purpose of 
that device; 

'sponsor'  means  any  individual,  company,  institution  or  organisation  which  takes 
responsibility for the initiation and management of a clinical performance study; 

'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 performance study, whether or not 
related to the device for performance evaluation; 

(47) 

'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, 

EN 

26 

   EN 

 
– 

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

(48) 

'device  deficiency'  means  any  inadequacy  in  the  identity,  quality,  durability, 
reliability,  safety  or  performance  of  a  device  for  performance  evaluation,  including 
malfunction,  use  errors  or  inadequacy  in  the  information  supplied  by  the 
manufacturer; 

Definitions related to vigilance and market surveillance: 

(49) 

(50) 

(51) 

(52) 

(53) 

(54) 

(55) 

(56) 

'recall' means any measure aimed at achieving the return of a device that has already 
been made available to the end user; 

'withdrawal'  means  any  measure  aimed  at  preventing  a  device  in  the  supply  chain 
from further being made available on the market; 

'incident'  means  any  malfunction  or  deterioration 
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 effect; 

in 

'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; 

'corrective  action'  means  action  taken  to  eliminate  the  cause  of  a  potential  or  real 
non-conformity or other undesirable situation; 

'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; 

'field  safety  notice'  means  the  communication  sent  by  the  manufacturer  to  users  or 
customers in relation to a field safety corrective action; 

'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: 

(57) 

(58) 

‘harmonised  standard’  means  a  European  standard  as  defined  in  Article  2(1)(c)  of 
Regulation (EU) No [Ref. of future Regulation on European standardisation]; 

'common  technical  specifications’  means  a  document  other  than  a  standard  that 
prescribes  technical  requirements  that  provide  a  means  to  comply  with  the  legal 
obligations applicable to a device, process or system. 

Article 3 

Regulatory status of products 

1. 

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  an  in  vitro  diagnostic  medical 

EN 

27 

   EN 

 
devices  or  of  an  accessory  to  an  in  vitro  diagnostic  medical  device.  Those 
implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 84(3). 

2. 

The Commission shall ensure the sharing of expertise between Member States in the 
fields  of  in  vitro  diagnostic  medical  devices,  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, 
CE marking, free movement 

1. 

2. 

3. 

4. 

5. 

6. 

Article 4 

Placing on the market and putting into service 

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 be based on clinical evidence in accordance with Article 47.  

Devices  that  are  manufactured  and  used  within  a  single  health  institution  shall  be 
considered as being put into service. 

With  the  exception  of  Article  59(4),  the  requirements  of  this  Regulation  shall  not 
apply to devices classified as class A, B and C, in accordance with the rules set out in 
Annex  VII,  and  manufactured  and  used  only  within  a  single  health  institution, 
provided  manufacture  and  use  occur  solely  under  the  health  institution's  single 
quality management system, and the health institution is compliant with standard EN 
ISO 15189 or any other equivalent recognised standard. Member States may require 
that  the  health  institutions  submit  to  the  competent  authority  a  list  of  such  devices 
which  have  been  manufactured  and  used  on  their  territory  and  may  make  the 
manufacture and use of the devices concerned subject to further safety requirements. 

Devices classified as class D in accordance with the rules set out in Annex VII, even 
if  manufactured  and  used  within  a  single  health  institution,  shall  comply  with  the 
requirements of this Regulation. However, the provisions regarding CE marking set 
out in Article 16 and the obligations referred to in Articles 21 to 25 shall not apply to 
those devices. 

The  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article  85,  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. 

EN 

28 

   EN 

 
1. 

2. 

1. 

2. 

1. 

2. 

3. 

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 is 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 performance studies, clinical evidence or post-
market 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.  

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 
evidence and post-market follow-up set out in Annex XII. The CTS shall be adopted 
by  means  of  implementing  acts  in  accordance  with  the  examination  procedure 
referred to in Article 84(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. 

EN 

29 

   EN 

 
1. 

2. 

3. 

4. 

5. 

6. 

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  85  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 devices for performance evaluation, shall draw 
up an EU declaration of conformity in accordance with Article 15 and affix the CE 
marking of conformity in accordance with Article 16. 

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  43,  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. 

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 
than devices for performance evaluation, shall institute and keep up to date a quality 
management system that shall address at least the following aspects: 

(a) 

(b) 

the responsibility of the management; 

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 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-

EN 

30 

   EN 

 
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  follow-up  in  accordance 
with  Part  B  of  Annex  XII.  Where  post-market  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  17  of  Annex  I  in  an  official  Union  language 
which  can  be  easily  understood  by  the  intended  user.  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.  

For  devices  for  self-testing  or  near-patient-testing,  the  information  supplied  in 
accordance  with  Section  17  of  Annex  I  shall  be  provided  in  the  language(s)  of  the 
Member State where the device reaches its intended user. 

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. 

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 23. 

Article 9 

Authorised representative 

1. 

2. 

3. 

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: 

EN 

31 

   EN 

 
(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  43  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. 

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.  

4. 

5. 

6. 

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; 

EN 

32 

   EN 

 
(d) 

the  obligation  of  the  outgoing  authorised  representative  after  the  end  of  the 
mandate  to  forward  to  the  manufacturer  or  to  the  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  

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) 

(d) 

(e) 

(f) 

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;  

that the device bears the required CE marking of conformity;  

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

that, where applicable, a Unique Device Identification has been assigned by the 
manufacturer in accordance with Article 22. 

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 23(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. 

1. 

2. 

3. 

4. 

5. 

6. 

EN 

33 

   EN 

 
7. 

8. 

9. 

10. 

1. 

2. 

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  43  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  43,  can  be 
made available to those authorities, upon request. By written mandate, the importer 
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) 

(b) 

(c) 

the product bears the required CE marking of conformity; 

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 22 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. 

EN 

34 

   EN 

 
3. 

4. 

5. 

6. 

1. 

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. 

Distributors who have received complaints or reports from healthcare professionals, 
patients  or  users  about  suspected  incidents  related  to  a  device  they  have  made 
available, shall immediately forward this information to the manufacturer and, where 
applicable, his authorised representative. 

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 

Manufacturers  shall  have  available  within  their  organisation  at  least  one  qualified 
person  who  possesses  expert  knowledge  in  the  field  of  in  vitro  diagnostic  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 in vitro diagnostic medical devices; 

(b) 

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

2. 

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

(a) 

(b) 

(c) 

(d) 

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;  

that the reporting obligations in accordance with Articles 59 to 64 are fulfilled. 

in  the  case  of  devices  for  performance  evaluation  intended  to  be  used  in  the 
context  of  interventional  clinical  performance  studies  or  other  clinical 

EN 

35 

   EN 

 
3. 

4. 

performance studies involving risks for the subjects, that the statement referred 
to in Section 4.1 of Annex XIII is issued; 

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  in  vitro  diagnostic  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 in vitro diagnostic medical 
devices;  

(b) 

five  years  of  professional  experience  in  regulatory  affairs  or  in  quality 
management systems relating to in vitro diagnostic 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  (16)  of  Article  2,  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  17  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 

36 

   EN 

 
3. 

4. 

1. 

2. 

3. 

4. 

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  27,  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 

EU declaration of conformity 

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. 

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 85 amending or supplementing the minimum content of the EU declaration of 
conformity set out in Annex III in the light of technical progress. 

EN 

37 

   EN 

 
1. 

2. 

3. 

4. 

5. 

6. 

1. 

2. 

3. 

1. 

Article 16 

CE marking of conformity 

Devices,  other  than  devices  for  performance  evaluation,  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  40.  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 17 

Devices for special purposes 

Member  States  shall  not  create  any  obstacle  to  devices  for  performance  evaluation 
which are supplied for that purpose to laboratories or other institutions, if they meet 
the conditions laid down in Articles 48 to 58. 

Those  devices  shall  not  bear  the  CE  marking,  with  the  exception  of  the  devices 
referred to in Article 52. 

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  such  devices  are  not  used  on  specimens  taken  from  the 
participants  and  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 18 

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; 

EN 

38 

   EN 

 
– 

– 

medical  devices  bearing  the  CE  marking  in conformity with Regulation (EU) 
[Ref. of future Regulation on medical devices]; 

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. 

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 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  the 
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 40. 

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 17 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 19 

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. 

3. 

4. 

5. 

1. 

EN 

39 

   EN 

 
2. 

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 20 

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. 

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

Article 21 

Identification within the supply chain 

For devices, other than devices for performance evaluation, economic operators shall be able 
to identify the following, for the period referred to in Article 8(4): 

(a) 

(b) 

(c) 

any economic operator to whom they have supplied a device; 

any economic operator who has supplied them with a device; 

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

Upon request, they shall inform the competent authorities thereof. 

Article 22 

Unique device identification system 

1. 

For  devices,  other  than  devices  for  performance  evaluation,  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) 

(ii) 

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

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: 

EN 

40 

   EN 

 
(a) 

(b) 

(c) 

(d) 

the entity is an organisation with legal personality; 

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. 

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  59.  The  device  identifier  shall  appear  on  the  EU  declaration  of  conformity 
referred to in Article 15 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 85: 

3. 

4. 

5. 

6. 

7. 

(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 
timelines 
risk-based  approach, 
implementation  of  the  UDI  system  shall  be  gradual,  starting  with  devices 
falling in the highest risk class; 

this.  Following  a 

implementing 

for 

(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 

EN 

41 

   EN 

 
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) 

(b) 

(c) 

(d) 

(e) 

the protection of personal data; 

the legitimate interest in protecting commercially sensitive information; 

the risk-based approach; 

the cost-effectiveness of the measures; 

the convergence of UDI systems developed at international level. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

Article 23 

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  device  for  performance  evaluation,  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  device  for  performance 
evaluation,  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 
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  85  amending  the  list  of  information  to  be  submitted  as  set  out  in  Part  A  of 
Annex V in the light of technical progress. 

EN 

42 

   EN 

 
Article 24 

Summary of safety and performance 

1. 

2. 

In the case of devices classified as class C and D, other than devices for performance 
evaluation, the manufacturer shall draw up a summary of safety and 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  40  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 
performance.  Those  implementing  acts  shall  be  adopted  in  accordance  with  the 
advisory procedure referred to in Article 84(2). 

Article 25 

European databank 

The  Commission  shall  develop  and  manage  the  European  databank  on  medical  devices 
(Eudamed)  in  accordance  with  the  conditions  and  modalities  established  by  Article  27  of 
Regulation (EU) [Ref. of future Regulation on medical devices].  

Eudamed shall include the following as integral parts: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

the electronic system on UDI referred to in Article 22;  

the  electronic  system  on  registration  of  devices  and  economic  operators 
referred to in Article 23; 

the electronic system on information on certificates referred to in Article 43(4);  

the  electronic  system  on  interventional  clinical  performance  studies  and 
clinical  performance  studies  involving  risks  for  the  subjects  set  up  in  Article 
51; 

the electronic system on vigilance referred to in Article 60; 

the electronic system on market surveillance referred to in Article 66. 

Chapter IV 
Notified Bodies 

Article 26 

National authorities responsible for notified bodies 

1. 

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'. 

EN 

43 

   EN 

 
2. 

3. 

4. 

5. 

6. 

7. 

8. 

1. 

2. 

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 interest 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 31(3), where a national authority is responsible for the 
designation of notified bodies in the field of products other than in vitro diagnostic 
medical devices, the competent authority for in vitro diagnostic medical devices shall 
be consulted on all aspects specifically related to such 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. 

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 27 

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  85  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 

EN 

44 

   EN 

 
Article 28 

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 29 

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, 
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 30 

Assessment of the application 

The national authority responsible for notified bodies shall check that the application 
referred to in Article 29 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  ('MDCG') 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

1. 

2. 

EN 

45 

   EN 

 
3. 

4. 

5. 

6. 

7. 

1. 

referred  to  in  Article  76.  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  29  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  29(2),  unless  the  Commission  representative  mentioned  in  Article  30(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. 
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  29  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 84(3). 

Article 31 

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. 

EN 

46 

   EN 

 
2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

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 in vitro diagnostic 
medical devices, the competent authority for in vitro diagnostic 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 84(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 
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 26(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. 

EN 

47 

   EN 

 
1. 

2. 

1. 

2. 

3. 

4. 

5. 

Article 32 

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  31.  It  shall  assign  a 
single identification number even when the body is notified under several Union acts. 

The  Commission  shall  make  accessible  to  the  public  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. The Commission shall 
ensure that the list is kept up to date. 

Article 33 

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. 

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 as 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 30(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. 

EN 

48 

   EN 

 
1. 

2. 

3. 

4. 

Article 34 

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 30(2) to (6) 
and in Article 31 shall apply to changes where they entail 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 31(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 
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) 

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

(b) 

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 in vitro 
diagnostic medical devices of the Member State in which the manufacturer of 

EN 

49 

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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. 

Article 35 

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 84(3). It shall notify the Member State 
concerned of its decision and update the database and list of notified bodies. 

Article 36 

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 37 

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 the coordination group of notified bodies 
referred to in Article 39 of Regulation [Ref. of future Regulation on medical devices]. 

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

Article 38 

Fees 

1. 

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 

EN 

50 

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2. 

1. 

2. 

3. 

4. 

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 85 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 
of innovation and cost-effectiveness. Particular attention shall be paid to the interests 
of  notified  bodies  that  received  a  certificate  delivered  by  the  national  accreditation 
body as referred to in Article 29(2) and notified bodies that are small and medium-
sized enterprises as defined by the Commission Recommendation 2003/361/EC38. 

Chapter V 
Classification and conformity assessment 

SECTION 1 – CLASSIFICATION 

Article 39 

Classification of in vitro diagnostic medical devices 

Devices shall be divided into class A, B, C and D, 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 84(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 59 to 
73, the Commission shall be empowered to adopt delegated acts in accordance with 
Article 85 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. 

38 

OJ L 124, 20.5.2003, p. 36 

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51 

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1. 

2. 

3. 

SECTION 2 – CONFORMITY ASSESSMENT 

Article 40  

Conformity assessment procedures 

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 X. 

Manufacturers  of  devices  classified  as  class  D,  other  than  devices  for  performance 
evaluation,  shall  be  subject  to  a  conformity  assessment  based  on  full  quality 
assurance, design dossier examination and batch verification, 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  production  quality  assurance  including  batch  verification,  as 
specified in Annex X. 

In addition, where a reference laboratory is designated in accordance with Article 78, 
the notified body performing the conformity assessment shall request that reference 
laboratory  to  verify  compliance  of  the  device  with  the  applicable  CTS,  when 
available,  or  with  other  solutions  chosen  by  the  manufacturer  to  ensure  a  level  of 
safety  and  performance  that  is  at  least  equivalent,  as  specified  in  Section  5.4  of 
Annex VIII and in Section 3.5 of Annex IX. 

For  companion  diagnostics  intended  to  be  used  to  assess  the  patient  eligibility  for 
treatment with a specific medicinal product, the notified body shall consult one of the 
competent authorities designated by the Member States in accordance with Directive 
2001/83/EC of the European Parliament and of the Council of 6 November 2001 on 
the Community code relating to medicinal products for human use 39 or the European 
Medicines Agency (EMA) in accordance with the procedures set out in Section 6.2 
of Annex VIII and in Section 3.6 of Annex IX. 

Manufacturers  of  devices  classified  as  class  C,  other  than  devices  for  performance 
evaluation,  shall  be  subject  to  a  conformity  assessment  based  on  full  quality 
assurance, as specified in Annex VIII, 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 conformity assessment based on 
production quality assurance, as specified in Annex X. 

In  addition,  for  devices  for  self-testing  and  near-patient  testing,  the  manufacturer 
shall fulfil the supplementary requirements set out in Section 6.1 of Annex VIII or in 
Section 2 of Annex IX. 

For  companion  diagnostic  intended  to  be  used  to  assess  the  patient  eligibility  to  a 
treatment with a specific medicinal product, the notified body shall consult one of the 
competent authorities designated by the Member States in accordance with Directive 
2001/83/EC  or  the  European  Medicines  Agency  (EMA)  in  accordance  with  the 
procedures set out in Section 6.2 of Annex VIII and in Section 3.6 of Annex IX. 

39 

OJ L 311, 28.11.2001, p. 67. 

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52 

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4. 

5. 

6. 

7. 

8. 

9. 

Manufacturers  of  devices  classified  as  class  B,  other  than  devices  for  performance 
evaluation,  shall  be  subject  to  a  conformity  assessment  based  on  full  quality 
assurance, as specified in Annex VIII. 

In  addition,  for  devices  for  self-testing  and  near-patient  testing,  the  manufacturer 
shall fulfil the supplementary requirements set out in Section 6.1 of Annex VIII. 

Manufacturers  of  devices  classified  as  class  A,  other  than  devices  for  performance 
evaluation,  shall  declare  the  conformity  of  their  products  by  issuing  the  EU 
declaration  of  conformity  referred  to  in  Article  15,  after  drawing  up  the  technical 
documentation set out in Annex II. 

However, if the devices are intended for near-patient testing, or if they are placed on 
the market in sterile condition or have a measuring function, the manufacturer shall 
apply  the  procedures  set  out  in  Annex  VIII  or  in  Annex  X.  Involvement  of  the 
notified body shall be limited: 

(a) 

(b) 

(c) 

in  the  case  of  devices  for  near-patient  testing,  to  the  requirements  set  out  in 
Section 6.1 of Annex VIII,  

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. 

Devices  for  performance  evaluation  shall  be  subject  to  the  requirements  set  out  in 
Articles 48 to 58. 

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. 

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 
classified as class C; 

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  frequency  of  samples  of  the  manufactured  devices  or  batches  of  devices 
classified  as  class  D  to  be  sent  to  a  reference  laboratory  designated  under 
Article  78  in  accordance  with  Section  5.7  of  Annex  VIII  and  Section  5.1  of 
Annex X, or 

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53 

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10. 

1. 

2. 

3. 

4. 

1. 

– 

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 and Sections 3.2 and 3.3 
of Annex IX. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination 
procedure referred to in Article 84(3). 

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 26 to 38, 
or of the vigilance and market surveillance activities described in Articles 59 to 73, 
the  Commission  shall  be  empowered  to  adopt  delegated  acts  in  accordance  with 
Article 85 amending or supplementing the conformity assessment procedures set out 
in Annexes VIII to X. 

Article 41 

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 
judgment  or  the  results  of  their  conformity  assessment  activities,  especially  as 
regards persons or groups with an interest in the results of those activities. 

Article 42 

Mechanism for scrutiny of certain conformity assessments 

Notified  bodies  shall  notify  the  Commission  of  applications  for  conformity 
assessments  for  devices  classified  as  class  D,  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  17.3  of  Annex  I  and  the  draft 
summary of safety and performance referred to in Article 24. 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. 

2. 

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 

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3. 

4. 

5. 

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) of Regulation [Ref. of future Regulation 
on medical devices]. 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. 

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 classified as class D, 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 84(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 59 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 

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7. 

8. 

1. 

2. 

3. 

4. 

5. 

1. 

to the public. It shall not disclose any personal data or information of commercially 
confidential nature. 

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 84(3). 

Article 43 

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 XI. 

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 
the  applicable  conformity  assessment  procedures.  Any 
in  accordance  with 
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  measures 
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 the electronic system information 
regarding  certificates 
including  amendments  and  supplements,  and 
information  regarding  suspended,  reinstated,  withdrawn  or  refused  certificates  and 
restrictions  imposed  on  certificates.  This  information  shall  be  accessible  to  the 
public. 

issued, 

In  the  light  of  technical  progress,  the  Commission  shall  be  empowered  to  adopt 
delegated  acts  in  accordance  with  Article  85  amending  or  supplementing  the 
minimum content of the certificates set out in Annex XI. 

Article 44 

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 

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defined  in  an  agreement  between  the  manufacturer,  the  outgoing  notified  body  and 
the  incoming  notified  body.  This  agreement  shall  address  at  least  the  following 
aspects: 

(a) 

(b) 

(c) 

(d) 

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

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; 

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

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 45 

Derogation from the conformity assessment procedures 

By  way  of  derogation  from  Article  40,  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 40 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 84(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 84(4). 

Article 46 

Certificate of free sale 

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 
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 43 issued for the device in question. 

2. 

1. 

2. 

3. 

1. 

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2. 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

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 84(2). 

Chapter VI 
Clinical evidence 

Article 47 

General requirements regarding clinical evidence 

The  demonstration  of  conformity  with  the  general  safety  and  performance 
requirements set out in Annex I, under normal conditions of use, shall be based on 
clinical evidence.  

The  clinical  evidence  shall  support  the  intended  purpose  of  the  device  as  stated  by 
the manufacturer. 

The  clinical  evidence  shall  include  all  the  information  supporting  the  scientific 
validity of the analyte, the analytical performance and, where applicable, the clinical 
performance of the device, as described in Section 1 of Part A of Annex XII. 

Where  demonstration  of  conformity  with  the  general  safety  and  performance 
requirements  based  on  clinical  performance  data  or  parts  thereof  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 
characteristics of the device and, in particular, its intended purpose(s), the intended 
performance and the claims of the manufacturer. The adequacy of demonstration of 
conformity  with  the  general  safety  and  performance  requirements  based  on  the 
results of analytical performance evaluation alone shall be duly substantiated in the 
technical documentation referred to in Annex II. 

The  scientific  validity  data,  the  analytical  performance  data  and,  where  applicable, 
the  clinical  performance  data  shall  be  summarised  as  part  of  a  clinical  evidence 
report referred to in Section 3 of Part A of Annex XII. The clinical evidence report 
shall  be  included  or  fully  referenced  in  the  technical  documentation  referred  to  in 
Annex II relating to the device concerned. 

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

The  manufacturer  shall ensure  that  the  device  for  performance  evaluation  complies 
with the general requirements of  this  Regulation apart  from the aspects covered  by 
the performance evaluation and that, with regard to those aspects, every precaution 
has been taken to protect the health and safety of the patient, user and other persons. 

The manufacturer shall undertake to keep available to the competent authorities and 
the  EU  reference  laboratories  the  documentation  allowing  an  understanding  of  the 
design,  manufacture  and  performances  of  the  device,  including  its  expected 
performance, so as to allow assessment of conformity with the requirements of this 
Regulation.  This  documentation  shall  be  kept  for  at  least  five  years  after  the 
performance evaluation of the device in question has ended. 

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General requirements regarding clinical performance studies 

Article 48 

1. 

Clinical performance studies shall be subject to this Regulation if they are conducted 
for one or more of the following purposes: 

(a) 

(b) 

(c) 

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

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

to  determine  any  limits  to  the  performance  of  the  devices,  under  normal 
conditions of use. 

Clinical  performance  studies  shall  be  performed  in  circumstances  similar  to  the 
normal conditions of use of the device. 

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 
communications  with 
this  Regulation.  Any 
communication  to  that  contact  person  shall  be  considered  as  communication  to  the 
sponsor. 

the  sponsor  provided  for 

in 

All  clinical  performance  studies  shall  be  designed  and  conducted  in  a  way  that  the 
rights,  safety  and  well-being  of  the  subjects  participating  in  such  clinical 
performance studies are protected and that the clinical data generated in the clinical 
performance study are going to be reliable and robust.  

All clinical performance studies shall be designed, conducted, recorded and reported 
in accordance with Section 2 of Annex XII. 

For interventional clinical performance studies, as defined in number (37) of Article 
2,  and  for  other  clinical  performance  studies,  where  the  conduct  of  the  study, 
including  specimen  collection,  involves  invasive  procedures  or  other  risks  for  the 
subjects  of  the  studies,  the  requirements  set  out  in  Articles  49  to  58  and  in  Annex 
XIII shall apply, in addition to the obligations laid down in this Article. 

2. 

3. 

4. 

5. 

6. 

Article 49 

Application for interventional clinical performance studies and other clinical performance 
studies involving risks for the subjects of the studies 

1. 

2. 

Before  making  the  first  application,  the  sponsor  shall  procure  from  the  electronic 
system  referred  to  in  Article  51  a  single  identification  number  for  a  clinical 
performance study 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 performance study in accordance with Article 50. 

The  sponsor  of  a  clinical  performance  study  shall  submit  an  application  to  the 
Member  State(s)  in  which  the  study  is  to  be  conducted  accompanied  by  the 
documentation  referred  to  in  Annex  XIII.  Within  six  days  after  receipt  of  the 
application, the Member State concerned shall notify the sponsor whether the clinical 

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performance  study  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  performance  study  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 performance study 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 performance study 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. 

3. 

4. 

5. 

The sponsor may start the clinical performance study in the following circumstances:  

(a) 

(b) 

(c) 

in the case of devices for performance evaluation classified as class C or D, as 
soon as the Member State concerned has notified the sponsor of its approval; 

in  the  case  of  devices  for  performance  evaluation  classified  as  class  A  or  B 
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 performance study 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. 

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 
study  site(s)  and  the  investigators  involved,  as  well  as  free  of  any  other  undue 
influence.  

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 85 amending or supplementing, in the light of technical progress and global 
regulatory  developments,  the  requirements  for  the  documentation  to  be  submitted 

6. 

7. 

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with the application for the clinical performance study that is laid down in Chapter I 
of Annex XIII. 

Article 50  

Registration of interventional clinical performance studies and other clinical performance 
studies involving risks for the subjects of the studies 

1. 

Before  commencing  the  clinical  performance  study,  the  sponsor  shall  enter  in  the 
electronic  system  referred  to  in  Article  51  the  following  information  regarding  the 
clinical performance study: 

(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

the single identification number of the clinical performance study; 

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  device  for  performance  evaluation,  if  different  from  the 
sponsor; 

the description of the device for performance evaluation; 

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

the purpose of the clinical performance study; 

the status of the clinical performance study. 

2. 

3. 

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 51. 

The  information  shall  be  accessible  to  the  public,  through  the  electronic  system 
referred to in Article 51, 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  performance  study  by  the 
Member State(s) concerned. 

4. 

No personal data of subjects participating in the clinical performance study shall be 
accessible to the public. 

Article 51 

Electronic system on interventional clinical performance studies and other clinical 
performance studies involving risks for the subjects of the studies 

1. 

The Commission shall, in collaboration with the Member States, set up and manage 
an electronic system on interventional clinical performance studies and other clinical 
performance studies involving risks for the subjects of the studies to create the single 
identification  numbers  for  such  clinical  performance  studies  referred  to  in  Article 
49(1) and to collate and process the following information: 

(a) 

the registration of clinical performance studies in accordance with Article 50; 

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(b) 

(c) 

(d) 

the exchange of information between the Member States and between them and 
the Commission in accordance with Article 54; 

the information related to clinical performance studies conducted in more than 
one Member State in case of a single application in accordance with Article 56; 

the  reports  on  serious  adverse  events  and  device  deficiencies  referred  to  in 
Article 57(2) in case of single application in accordance with Article 56. 

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 
[Ref.  of  future  Regulation  on  clinical  trials].  With  the  exception  of  the  information 
referred  to  in  Article  50,  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  85  determining  which  other  information  regarding  clinical  performance 
studies 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 [Ref. of future Regulation on clinical 
trials]. Article 50(3) and (4) shall apply. 

2. 

3. 

Article 52 

Interventional clinical performance studies and other clinical performance studies involving 
risks for the subjects of the studies with devices authorised to bear the CE marking 

1. 

2. 

Where  a  clinical  performance  study  is  to  be  conducted  to  further  assess  devices 
which  are  authorised  in  accordance  with  Article  40  to  bear  the  CE  marking  and 
within  its  intended  purpose  referred  to  in  the  relevant  conformity  assessment 
procedure, hereinafter referred to as ‘post-market follow-up performance study’, the 
sponsor  shall  notify  the  Member  States  concerned  at  least  30  days  prior  to  their 
commencement  if  the  study  would  submit  subjects  to  additionally  invasive  or 
burdensome  procedures.  Articles  48(1)  to  (5),  50,  53,  54(1)  and  55(1),  the  first 
subparagraph of Article 55(2) and the relevant provisions of Annexes XII and XIII 
shall apply. 

If the aim of the clinical performance study regarding a device which is authorised in 
accordance  with  Article  40  to  bear  the  CE  marking  is  to  assess  such  device  for  a 
purpose other than that referred to in the information supplied by the manufacturer in 
accordance  with  Section  17  of  Annex  I  and  in  the  relevant  conformity  assessment 
procedure, Articles 48 to 58 shall apply. 

Article 53 

Substantial modifications to interventional clinical performance studies and other clinical 
performance studies involving risks for the subjects of the studies 

1. 

If the sponsor introduces modifications to a clinical performance study 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 study, 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 Annex XIII. 

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2. 

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 54 

Information exchange between Member States on interventional clinical performance studies 
and other clinical performance studies involving risks for the subjects of the studies 

1. 

2. 

Where a Member State has refused, suspended or terminated a clinical performance 
study,  or  has  called  for  a  substantial  modification  or  temporary  halt  of  a  clinical 
performance study, or has been notified by the sponsor of the early termination of a 
clinical performance study 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 51. 

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 51. 

Article 55 

Information by the sponsor in the event of temporary halt or termination of interventional 
clinical performance studies or of other clinical performance studies involving risks for the 
subjects of the studies 

1. 

2. 

3. 

If the sponsor has temporarily halted a clinical performance study 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 
performance study 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 performance study in relation to that Member State. 

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

Within  one  year  from  the  end  of  the  clinical  performance  study,  the  sponsor  shall 
submit  to  the  Member  States  concerned  a  summary  of  the  results  of  the  clinical 
performance  study  in  form  of  a  clinical  performance  study  report  referred  to  in 
Section 2.3.3 of Part A of Annex XII. Where, for scientific reasons, it is not possible 
to submit the clinical performance study report within one year, it shall be submitted 
as  soon  as  it  is  available.  In  this  case,  the  clinical  performance  study  protocol 
referred to in Section 2.3.2 of Part A of Annex XII shall specify when the results of 
the  clinical  performance  study  are  going  to  be  submitted,  together  with  an 
explanation.  

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Interventional clinical performance studies and other clinical performance studies involving 
risks for the subjects of the studies conducted in more than one Member State 

Article 56 

1. 

2. 

3. 

4. 

5. 

6. 

By  means  of  the  electronic  system  referred  to  in  Article  51,  the  sponsor  of  the 
clinical  performance  study  to  be  conducted  in  more  than  one  Member  State  may 
submit,  for  the  purpose  of  Article  49,  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 deadlines referred to in Article 49(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  I  of  Annex 
XIII, except for Sections 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  performance  study  falls  within  the  scope  of  this  Regulation  and 
whether the application is complete, except for the documentation submitted in 
accordance with Sections 4.2, 4.3 and 4.4 of Chapter I of Annex XIII for which 
each  Member  State  shall  verify  the  completeness.  Article  49(2)  to  (4)  shall 
apply to the coordinating Member State in relation to the verification that the 
clinical performance study falls within the scope of this Regulation and that the 
application is complete, except for the documentation submitted in accordance 
with Sections 4.2, 4.3 and 4.4 of Chapter I of Annex XIII. Article 49(2) to (4) 
shall  apply  to  each  Member  State  in  relation  to  the  verification  that  the 
documentation  submitted  in  accordance  with  Sections  4.2,  4.3  and  4.4  of 
Chapter I of Annex XIII is complete; 

(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 49(5). 

The  substantial  modifications  referred  to  in  Article  53  shall  be  notified  to  the 
Member States concerned by means of the electronic system referred to in Article 51. 
Any assessment as to whether there are grounds for refusal as referred to in Article 
53 shall be carried out under the direction of the coordinating Member State. 

For  the  purpose  of  Article  55(3),  the  sponsor  shall  submit  the  clinical  performance 
study  report  to  the  Member  States  concerned  by  means  of  the  electronic  system 
referred to in Article 51. 

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

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Article 57 

Recording and reporting of events occurring during interventional clinical performance 
studies and other clinical performance studies involving risks for the subjects of the studies 

1. 

The sponsor shall fully record any of the following: 

(a) 

(b) 

(c) 

an adverse event identified in the clinical performance study protocol as critical 
to the evaluation of the results of the clinical performance study in view of the 
purposes referred to in Article 48(1); 

a serious adverse event;  

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 performance study is 
conducted without delay any of the following: 

3. 

4. 

(a) 

(b) 

a  serious  adverse  event  that  has  a  causal  relationship  with  the  device  for 
performance evaluation, the comparator or the study 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. 

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 performance study is 
performed under the same clinical performance study protocol as the one applying to 
a clinical performance study covered by this Regulation. 

In the case of a clinical performance study for which the sponsor has used the single 
application referred to in Article 56, the sponsor shall report any event as referred to 
in  paragraph  2  by  means  of  the  electronic  system  referred  to  in  Article  51.  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 56(2), the 
Member States shall coordinate their assessment of serious adverse events and device 
deficiencies  to  determine  whether  a  clinical  performance  study  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. 

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5. 

In the case of post-market follow-up performance studies referred to in Article 52(1), 
the provisions on vigilance contained in Articles 59 to 64 shall apply instead of this 
Article. 

Article 58 

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 performance studies and their 
assessment  as  referred  to  in  Articles  49  and  56,  taking  into  account  specific 
categories or groups of devices; 

(b) 

the functioning of the electronic system referred to in Article 51; 

(c)  harmonised  forms  for  the  notification  of  post-market  follow-up  performance 
studies  as  referred  to  in  Article  52(1),  and  of  substantial  modifications  as 
referred to in Article 53; 

(d) 

the  exchange  of  information  between  Member  States  as  referred  to  in  Article 
54; 

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

deficiencies as referred to in Article 57; 

(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 57. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 84(3). 

Chapter VII 
Vigilance and market surveillance 

SECTION 1 — VIGILANCE 

Article 59 

Reporting of incidents and field safety corrective actions 

1. 

Manufacturers of devices, other than devices for performance evaluation, shall report 
through the electronic system referred to in Article 60 the following: 

(a) 

(b) 

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

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 

EN 

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2. 

3. 

4. 

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  60(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. 

Health institutions manufacturing and using devices referred to in Article 4(4) 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  health 
institution is located. 

Article 60 

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) 

(b) 

(c) 

(d) 

(e) 

(f) 

the  reports  by  manufacturers  on  serious  incidents  and  field  safety  corrective 
actions referred to in Article 59(1); 

the periodic summary reports by manufacturers referred to in Article 59(2); 

the  reports  by  competent  authorities  on  serious  incidents  referred  to  in  the 
second subparagraph of Article 61(1); 

the reports by manufacturers on trends referred to in Article 62; 

the field safety notices by manufacturers referred to in Article 61(4); 

the  information  to  be  exchanged  between  the  competent  authorities  of  the 
Member  States  and  between  them  and  the  Commission  in  accordance  with 
Article 61(3) and (6). 

2. 

3. 

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.  

EN 

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   EN 

 
4. 

5. 

1. 

2. 

3. 

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 59(1), the periodic summary reports referred to in Article 
59(2),  the  reports  on  serious  incidents  referred  to  in  the  second  subparagraph  of 
Article  61(1)  and  the  trend  reports  referred  to  in  Article  62  shall  be  automatically 
transmitted upon receipt via the electronic system to the competent authorities of the 
following Member States 

(a) 

(b) 

the Member State where the incident occurred;  

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

(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  43  for  the  device  in  question,  is 
established. 

Article 61 

Analysis of serious incidents and field safety corrective action  

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  59  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  59(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 60, 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. 

After carrying out the assessment, the evaluating competent authority shall, through 
the  electronic  system  referred  to  in  Article  60,  inform  without  delay  the  other 
competent authorities of the corrective action taken or envisaged by the manufacturer 
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. 

EN 

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4. 

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  5  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 60 through which that notice shall be accessible to the public. 

5. 

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. 

6. 

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  43  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  60(5)  on  the  format,  content  and  frequency  of 
periodic summary reports in accordance with Article 59(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 60, of the progress in and the outcome 
of its assessment. 

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.  

7. 

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

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Article 62 

Trend reporting 

Manufacturers  of  devices  classified  in  class  C  or  D  shall  report  to  the  electronic  system 
referred  to  in  Article  60  any  statistically  significant  increase  in  the  frequency  or  severity  of 
incidents  that  are  not  serious  incidents  or  of  expected  undesirable  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  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 61 shall apply. 

Article 63 

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 59, trend reports referred to 
in  Article  62  and  field  safety  notices  referred  to  in  Article  61(4).  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 64 

Implementing acts 

The Commission may, by means of implementing acts, adopt the modalities and procedural 
aspects necessary for the implementation of Articles 59 to 63 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 59 and 62;  

trend 

(c) 

timelines  for  the  reporting  of  serious  incidents  and  field  safety  corrective 
actions,  periodic  summary  reports  and  trend  reports  by  manufacturers,  taking 
into account the severity of the event to be reported as referred to in Articles 59 
and 62; 

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

authorities as referred to in Article 61. 

Those  implementing  acts  shall  be  adopted  in  accordance  with  the  examination  procedure 
referred to in Article 84(3). 

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SECTION 2 — MARKET SURVEILLANCE 

Article 65 

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 66 

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: 

(a) 

(b) 

(c) 

(d) 

information in relation to non-compliant devices presenting a risk to health and 
safety referred to in Article 68(2), (4) and (6); 

information  in  relation  to  compliant  devices  presenting  a  risk  to  health  and 
safety referred to in Article 70(2); 

information  in  relation  to  formal  non-compliance  of  products  referred  to  in 
Article 71(2); 

information in relation to preventive health protection measures referred to in 
Article 72(2). 

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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 67 

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. 

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

Article 68 

1. 

2. 

3. 

4. 

5. 

Where,  having  performed  an  evaluation  pursuant  to  Article  67,  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 
66. 

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. 

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 66. 

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.  

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6. 

7. 

8. 

1. 

2. 

3. 

1. 

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 66. 

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 69  

Procedure at Union level 

Where, within two months of receipt of the notification referred to in Article 68(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 84(3). 

If  the  national  measure  is  considered  justified,  Article  68(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 68  and 70, 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 
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 84(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 84(4). 

Article 70 

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

Where, having performed an evaluation pursuant to Article 67, 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 

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2. 

3. 

4. 

1. 

2. 

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 
66.  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 
84(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 84(4).  

Where the national measure is considered justified, Article 68(8) shall apply. If the 
national  measure  is  considered  unjustified,  the  Member  State  concerned  shall 
withdraw the measure. 

Article 71 

Formal non-compliance 

Without prejudice to Article 68, 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:  

(a) 

(b) 

(c) 

(d) 

(e) 

that  the  CE  marking  has  been  affixed  in  violation  of  the  formal  requirements 
laid down in Article 16; 

that the CE marking has not been affixed to a device contrary to Article 16; 

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 66. 

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1. 

2. 

3. 

4. 

1. 

2. 

Article 72 

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 66. 

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 84(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 84(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 85 to take the 
necessary and duly justified measures. 

Where in this case imperative grounds of urgency so require, the procedure provided 
for in Article 86 shall apply to delegated acts adopted pursuant to this paragraph. 

Article 73 

Good administrative practice 

Any measure adopted by the competent authorities of the Member States pursuant to 
Articles  68  to  72  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 

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3. 

4. 

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 68 to 72 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 

1. 

2. 

1. 

2. 

Article 74 

Competent authorities  

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 
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  48  to  58,  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 75 

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 76 

Medical Device Coordination Group 

The  Medical  Device  Coordination  Group  (MDCG)  established  in  accordance  with  the 
conditions and modalities defined in Article 78 of Regulation (EU) [Ref. of future Regulation 
on medical devices] shall carry out, with the support of the Commission as provided in Article 
79 of that Regulation, the tasks assigned to it by this Regulation. 

The MDCG shall have the following tasks: 

Article 77  

Tasks of the MDCG 

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(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

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 42; 

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; 

to  assist the  competent  authorities of the Member States in their coordination 
activities  in  the  fields  of  clinical  performance  studies,  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  in  vitro 
diagnostic medical devices in the Member States. 

Article 78 

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  verify  compliance  of  class  D  devices  with  the  applicable  CTS,  when 
available, or with other solutions chosen by the manufacturer to ensure a level 
of  safety  and  performance  that  is  at  least  equivalent,  as  provided  for  in  the 
second subparagraph of Article 40(2); 

to  carry  out  appropriate  tests  on  samples  of  manufactured  class  D  devices  or 
batches  of  class  D  devices,  as  provided  for  in  the  Section  5.7  of  Annex  VIII 
and in Section 5.1 of Annex X; 

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; 

(f) 

to contribute to the development of appropriate testing and analysis methods to 
be applied for conformity assessment procedures and market surveillance; 

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(g) 

(h) 

(i) 

(j) 

to collaborate with notified bodies in the development of best practices for the 
performance of conformity assessment procedures; 

to  provide  recommendations  on  suitable  reference  materials  and  reference 
measurement procedures of higher metrological order;  

to contribute to the development of standards at international level; 

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) 

(b) 

(c) 

(d) 

(e) 

(f) 

(g) 

to have appropriately qualified staff with adequate knowledge and experience 
in  the  field  of  the  in  vitro  diagnostic  medical  devices  for  which  they  are 
designated; 

to possess the necessary equipment and reference material to carry out the tasks 
assigned to them; 

to have the necessary knowledge of international standards and best practices; 

to have an appropriate administrative organisation and structure; 

to ensure that their staff observe the confidentiality of the information and data 
obtained in carrying out their tasks; 

to act in the public interest and in an independent manner; 

to ensure that their staff do not have financial or other interests in the in vitro 
diagnostic  medical  device  industry  which  could  affect  their  impartiality, 
declare  any  other  direct  and  indirect  interests  they  may  have  in  the  in  vitro 
diagnostic  medical  device  industry  and  update  this  declaration  whenever  a 
relevant change occurs. 

4. 

EU reference laboratories may be granted a Union financial contribution. 

5. 

6. 

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 84(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 85 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 

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Regulation,  taking  into  account  the  objectives  of  protection  of  human  health 
and safety, support of innovation and cost-effectiveness. 

7. 

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 79 

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 80 

Confidentiality 

1. 

2. 

3. 

4. 

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. 

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. 

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Article 81 

Data protection 

1. 

2. 

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 82 

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 83 

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 shall 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  this  Regulation]  and  shall  notify  it  without  delay  of  any  subsequent 
amendment affecting them. 

Chapter X 
Final provisions  

Article 84 

Committee procedure 

1. 

2. 

3. 

4. 

1. 

The Commission shall be assisted by the Committee on Medical Devices set up by 
Article 88 of Regulation (EU) [Ref. of future Regulation on medical devices]. 

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. 

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 85 

Exercise of the delegation 

The power to adopt the delegated acts referred to in Articles 4(6), 8(2), 15(4), 22(7), 
23(7), 27(2), 38(2), 39(4), 40(10), 43(5), 49(7), 51(3), 72(4) and 78(6) is conferred 
on the Commission subject to the conditions laid down in this Article. 

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2. 

3. 

4. 

5. 

1. 

2. 

1. 

2. 

The delegation of power referred to in Articles 4(6), 8(2), 15(4), 22(7), 23(7), 27(2), 
38(2),  39(4),  40(10),  43(5),  49(7),  51(3),  72(4)  and  78(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 4(6), 8(2), 15(4), 22(7), 23(7), 27(2), 
38(2), 39(4), 40(10), 43(5), 49(7), 51(3), 72(4) and 78(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 86 

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  85.  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.  

Article 87 

Transitional provisions  

From  the  date  of  application  of  this  Regulation  any  publication  of  a  notification  in 
respect of a notified body in accordance with Directive 98/79/EC shall become void.  

Certificates issued by notified bodies in accordance with Directive 98/79/EC 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 
VI of Directive 98/79/EC 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 Directive 98/79/EC after the 
entry into force of this Regulation shall become void at the latest two years after the 
date of application of this Regulation.  

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3. 

4. 

5. 

6. 

By  way  of  derogation  from  Directive  98/79/EC,  devices  which  comply  with  this 
Regulation may be placed on the market before its date of application.  

By way of derogation from Directive 98/79/EC, 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  10  and  points  (a)  and  (b)  of  Article  12(1)  of 
Directive  98/79/EC,  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 23(2) and (3) and Article 43(4) of this 
Regulation shall be considered to comply with the laws and regulations adopted by 
Member States in accordance with Article 10 and points (a) and (b) of Article 12(1) 
of Directive 98/79/EC as specified in Commission Decision 2010/227/EU. 

Authorisations granted by competent authorities of the Member States in accordance 
with  Article  9(12)  of  Directive  98/79/EC  shall  keep  the  validity  indicated  in  the 
authorisation.  

Article 88 

Evaluation 

No  later  than  five  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  this  Regulation  including  an  assessment  of  resources 
required to implement this Regulation.  

Article 89 

Repeal 

Directive  98/79/EC  of  the  European  Parliament  and  of  the  Council  is  repealed  with  effect 
from [date of application of this Regulation] with the exception of Article 10 and points (a) 
and  (b)  of  Article  12(1)  of  Directive  98/79/EC  which  are  repealed  with  effect  from  [18 
months after date of application]. 

References to the repealed Directive shall be understood as reference to this Regulation and 
shall be read in accordance with the correlation table laid down in Annex XIV. 

Article 90 

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 [five years after entry into force]. 

By way of derogation from paragraph 2, the following shall apply: 

(a)  Article 23(2) and (3) and Article 43(4) shall apply from [18 months after date 

of application referred to in paragraph 2]; 

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(b)  Articles 26 to 38 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 26 to 38 shall apply 
only to those bodies which submit an application for notification in accordance 
with Article 29 of this Regulation.  

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

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 

ANNEXES  

Technical documentation  

EU Declaration of conformity  

CE marking of conformity  

Information to be submitted with the registration of devices and economic operators 
in  accordance  with  Article  23  and  data  elements  of  the  UDI  device  identifier  in 
accordance with Article 22 

Minimum requirements to be met by Notified Bodies  

Classification criteria  

I 

II 

III 

IV 

V 

VI 

VII 

VIII 

Conformity assessment based on full quality assurance and design examination  

IX 

X 

XI 

XII 

XIII 

Conformity assessment based on type examination  

Conformity assessment based on production quality assurance 

Minimum content of certificates issued by a notified body  

Clinical evidence and post-market follow-up 

Interventional  clinical  performance  studies  and  other  clinical  performance  studies 
involving risks for the subjects of the studies 

XIV 

Correlation table 

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GENERAL SAFETY AND PERFORMANCE REQUIREMENTS  

ANNEX I  

I. GENERAL REQUIREMENTS 

1. 

2. 

3. 

4. 

The  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, directly or indirectly, the 
clinical  condition  or  the  safety  of  the  patients,  or  the  safety  or  health  of  users  or, 
where  applicable,  other  persons,  provided  that  any  risks  or  limits  to  performance 
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  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  or  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 
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. 

The devices shall be designed, manufactured and packaged in such a way that their 
characteristics  and  performance  during  their  intended  use  will  not  be  adversely 
affected by transport and storage conditions (for example, fluctuations of temperature 

EN 

85 

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and  humidity)  taking  account  of  the  instructions  and  information  provided  by  the 
manufacturer. 

5. 

All known and foreseeable risks, and any undesirable effects, shall be minimised and 
be  acceptable  when  weighed  against  the  benefits  to  the  patients  of  the  intended 
performance of the device during normal conditions of use.  

II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION 

6. 

6.1. 

Performance characteristics 

The devices shall be designed and manufactured in such a way that the performance 
characteristics  support  the  intended  purpose,  based  on  appropriate  scientific  and 
technical  methods.  They  shall  achieve  the  performances,  as  stated  by  the 
manufacturer and in particular, where appropriate: 

(a) 

the  analytical  performance,  such  as  accuracy  (trueness  and  precision), 
bias,  analytical  sensitivity,  analytical  specificity,  limits  of  detection  and 
quantitation,  measuring 
repeatability, 
reproducibility,  including  determination  of  appropriate  criteria  for 
specimen  collection  and  handling  and  control  of  known  relevant 
endogenous and exogenous interference, cross-reactions; and  

linearity, 

cut-off, 

range, 

(b) 

the  clinical  performance,  such  as  diagnostic  sensitivity,  diagnostic 
specificity,  positive  and  negative  predictive  value,  likelihood  ratio, 
expected values in normal or affected populations. 

6.2. 

The  performance  characteristics  of  the  device  need  to  be  maintained  during  the 
lifetime of the device as indicated by the manufacturer. 

6.3.  Where  the  performance  of  devices  depends on the use of calibrators and/or  control 
materials, the metrological traceability of values assigned for a given analyte to such 
calibrators  and/or  control  materials  shall  be  assured  through  available  and  suitable 
reference measurement procedures and/or available and suitable reference materials 
of  a  higher  metrological  order.  The  device  shall  be  designed  and  manufactured  to 
enable the user  to provide measurement results  in  patient  specimens metrologically 
traceable to available and suitable higher order reference materials and/or reference 
measurement procedures following the instructions and information provided by the 
manufacturer. 

7. 

7.1. 

7.2. 

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  the  possibility  of  impairment  of  analytical 
performance  due  to  incompatibility  between  the  materials  used  and  the  specimens 
and/or analyte to be detected (such as biological tissues, cells, body fluids and micro-
organisms), taking account of the intended purpose of the device. 

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. 

EN 

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7.3. 

7.4. 

8. 

8.1. 

8.2. 

8.3. 

8.4. 

8.5. 

The devices shall be designed and manufactured in such a way as to reduce as far as 
possible  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 1907/200640, 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)41

 . 

The devices shall be designed and manufactured in such a way as to reduce as far as 
possible the 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. 

Infection and microbial contamination 

The devices and their manufacturing processes shall be designed in such a way as to 
eliminate or reduce as far as possible the risk of infection to the user, professional or 
lay, or, where applicable, other persons. 

The design shall: 

(a) 

allow easy and safe 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. 

The devices labelled either as sterile or 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, until the protective packaging is damaged or opened. 

The 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. 

The  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  device  indicated  by  the  manufacturer  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. 

40 
41 

OJ L 353, 31.12.2008, p. 1. 
OJ L 136, 29.5.2007, p.3. 

EN 

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8.6. 

The  labelling  of  the  devices  shall  distinguish  between  identical  or  similar  products 
placed on the market in both sterile and non-sterile condition. 

9. 

Devices incorporating materials of biological origin 

9.1.  Where the devices include tissues, cells and substances originating from animals, the 
processing, preservation, testing and handling of tissues, cells and substances of such 
origin  shall  be  carried  out  so  as  to  provide  optimal  safety  for  user,  professional  or 
lay, or other person. 

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. This may not apply to certain devices if the 
activity of the virus and other transmissible agent are integral to the intended purpose 
of  the  device  or  when  such  elimination  or  inactivation  process  would  compromise 
the performance of the device. 

9.2.  Where  the  devices  include  human  tissues,  cells  or  substances,  the  selection  of 
sources,  donors  and/or  substances  of  human  origin,  the  processing,  preservation, 
testing  and  handling  of  tissues,  cells  and  substances  of  such  origin  shall  be  carried 
out so as to provide optimal safety for user, professional or lay, or other person. 

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. This may not apply to certain devices if the 
activity of the virus and other transmissible agent are integral to the intended purpose 
of  the  device  or  when  such  elimination  or  inactivation  process  would  compromise 
the performance of the device. 

9.3.  Where  the  devices  include  cells  or  substances  of  microbial  origin,  the  processing, 
preservation, testing and handling of cells and substances shall be carried out so as to 
provide optimal safety for user, professional or lay, or other person. 

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. This may not apply to certain devices if the 
activity of the virus and other transmissible agent are integral to the intended purpose 
of  the  device  or  when  such  elimination  or  inactivation  process  would  compromise 
the performance of the device. 

Interaction of devices with their environment 

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 performances 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 shall be designed and constructed in such a 
way as to minimise all possible risks from incorrect connection. 

10. 

10.1. 

10.2. 

The  devices  shall  be  designed  and  manufactured  in  such  a  way  as  to  remove  or 
reduce as far as possible and appropriate: 

(a) 

(b) 

the  risks  of  injury  to  user,  professional  or  lay,  or  other  person  in  connection 
with their physical and ergonomic features; 

the  risks  of  use  error  due  to  the  ergonomic  features,  human  factors  and  the 
environment in which the device is intended to be used;  

EN 

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(c) 

(d) 

(e) 

(f) 

(g) 

(h) 

the risks connected with any foreseeable external influences or environmental 
conditions,  such  as  magnetic  fields,  external  electrical  and  electromagnetic 
effects,  electrostatic  discharge,  pressure,  humidity,  temperature  variations  or 
radio signal interferences; 

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; 

the risks associated with the possible negative interaction between software and 
the environment within which it operates and interacts; 

the risks of accidental ingress of substances into the device; 

the risk of incorrect identification of specimens; 

the risks of any foreseeable interference with other devices. 

10.3. 

10.4. 

10.5. 

10.6. 

10.7. 

The  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. 

The  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. 

The 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. 

The  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, professional 
or lay, or other person. 

The  measuring,  monitoring  or  display  scale  (including  colour  change  and  other 
visual  indicators)  shall  be  designed  and  manufactured  in  line  with  ergonomic 
principles, taking account of the intended purpose of the device. 

11. 

Devices with a measuring function 

11.1. 

The  devices  having  a  primary  analytical  measuring  function  shall  be  designed  and 
manufactured in such a way as to provide sufficient accuracy, precision and stability 
of measurement within appropriate accuracy limits, taking into account the intended 
purpose  of  the  device  and  of  available  and  appropriate  reference  measurement 
procedures and materials. The accuracy limits shall be specified by the manufacturer. 

11.2. 

The  measurements  made  by  devices  with  a  measuring  function  and  expressed  in 
legal units shall conform to the provisions of Council Directive 80/181/EEC42. 

12. 

Protection against radiation 

12.1. 

The  devices  shall  be  designed,  manufactured  and  packaged  in  such  a  way  that 
exposure  of  user,  professional  or  lay,  or  other  persons  to  the  emitted  radiation 
(intended, unintended, stray or scattered) is reduced as far as possible. 

42 

OJ L 39, 15.2.1980. 

EN 

89 

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12.2.  When the devices are intended to emit potentially hazardous, visible and/or invisible 

radiation, they shall as far as possible be:  

(a)  designed and manufactured in such a way as to ensure that the characteristics 
and the quantity of radiation emitted can be controlled and/or adjusted; and 

(b) 

fitted with visual displays and/or audible warnings of such emissions. 

The  operating  instructions  for  devices  emitting  radiation  shall  give  detailed 
information  as  to  the  nature  of  the  emitted  radiation,  means  of  protecting  the  user, 
and on ways of avoiding misuse and of eliminating the risks inherent in installation. 

Software incorporated in devices and standalone software 

The  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  purpose.  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. 

For the devices that incorporate software or for standalone software that are devices 
in  themselves,  the  software  shall  be  developed  and  manufactured  according  to  the 
state  of  the  art  taking  into  account  the  principles  of  development  life  cycle,  risk 
management, verification and validation. 

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). 

Devices connected to or equipped with an energy source 

For  the  devices  connected  to  or  equipped  with  an  energy  source,  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. 

The devices where the safety of the patient depends on an internal power supply in 
the  device  shall  be  equipped  with  a  means  of  determining  the  state  of  the  power 
supply. 

The devices shall be designed and manufactured in such a way as to reduce as far as 
possible  the  risks  of  creating  electromagnetic  interference  which  could  impair  the 
operation of this or other devices or equipment in the intended environment. 

The  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. 

The 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  user,  professional  or  lay,  or 
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. 

Protection against mechanical and thermal risks 

The devices shall be designed and manufactured in such a way as to protect the user, 
professional or lay, or other person against mechanical risks.  

12.3. 

13. 

13.1. 

13.2. 

13.3. 

14. 

14.1. 

14.2. 

14.3. 

14.4. 

14.5. 

15. 

15.1. 

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15.2. 

The devices shall be sufficiently stable under the foreseen operating conditions. They 
shall be suitable to withstand stresses inherent in the foreseen working environment, 
and to retain this resistance during the expected lifetime of the devices, subject to any 
inspection and maintenance requirements as indicated by the manufacturer. 

15.3.  Where there are risks due to the presence of moving parts, risks due to break-up or 
detachment,  or  leakage  of  substances,  then  appropriate  protection  means  shall  be 
incorporated. 

15.4. 

15.5. 

15.6. 

15.7. 

Any  guards  or  other  means  included  with  the  device  to  provide  protection,  in 
particular against moving parts, shall be secure and shall not interfere with access for 
the normal operation of the device, or restrict routine maintenance  of the device as 
intended by the manufacturer. 

The  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. 

The  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 progress and of the means available to reduce noise, particularly at source, 
unless the noise emitted is part of the specified performance.  

Terminals  and  connectors  to  the  electricity,  gas  or  hydraulic  and  pneumatic  energy 
supplies  which  the  user,  professional  or  lay,  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. 

15.8.  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. 

16. 

16.1. 

Protection against the risks posed by devices intended by the manufacturer for 
self-testing or near-patient testing 

The  devices  intended  for  self-testing  or  near-patient  testing  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  the  intended  user 
and  the  influence  resulting  from  variation  that  can  be  reasonably  anticipated  in  the 
intended  user's  technique  and  environment.  The  information  and  instructions 
provided by the manufacturer shall be easy for the intended user to understand and 
apply.  

16.2. 

The  devices  intended  for  self-testing  or  near-patient  testing  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 

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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, the specimen, and also in the interpretation of the 
results. 

16.3. 

The devices intended for self-testing and near-patient testing shall, where reasonably 
possible, include a procedure by which the intended user can: 

– 

– 

verify  that,  at  the  time  of  use,  the  device  will  perform  as  intended  by  the 
manufacturer; and 

be warned if the device has failed to provide a valid result. 

III. REQUIREMENTS REGARDING INFORMATION SUPPLIED WITH THE DEVICE  

17. 

Label and instructions for use 

17.1.  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:  

(i) 

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. 

(ii) 

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.  

In duly justified and exceptional cases instructions for use may not be needed or may 
be abbreviated if the device can be used safely and as intended by the manufacturer 
without any such instructions for use. 

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. 

When the device is intended for professional use only , instructions for use may be 
provided to the user in non-paper format (e.g. electronic), except when the device is 
intended for near-patient testing. 
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. 

(iii) 

(iv) 

(v) 

(vi) 

(vii)  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 

EN 

92 

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(viii) 

symbols  and  colours  shall  be  described  in  the  documentation  supplied  with  the 
device. 

In the case of devices containing a substance or a mixture which may be considered 
as being dangerous, taking account of the nature and quantity of its constituents and 
the  form  under  which  they  are  present,  relevant  hazard  pictograms  and  labelling 
requirements of Regulation (EC) 1272/2008 shall apply. Where there is insufficient 
space to put all the information on the device itself or on its label, the relevant hazard 
pictograms  shall  be  put  on  the  label  and  the  other  information  required  by  that 
Regulation shall be given in the instructions for use. 

(ix) 

The  provisions  of  Regulation  (EC)  1907/2006  on  the  safety  data  sheet  shall  apply, 
unless  all  relevant  information  as  appropriate  is  already  made  available  by  the 
instructions for use. 

17.2. 

Information on the label 

The label shall bear the following particulars:  

(i) 

(ii) 

(iii) 

(iv) 

(v) 

(vi) 

The name or trade name of the device; 

The details strictly necessary for the user to identify the device and, where it is not 
obvious for the user, the intended purpose of the device; 

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; 

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; 

An indication that the device is for in vitro diagnostic use;  

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; 

(vii)  Where applicable, the unique device identification (UDI); 

(viii)  An  unambiguous  indication  of  the  date  until  when  the  device  may  be  used  safely, 
without  degradation  of  performance,  expressed  at  least  as  the  year,  the  month  and, 
where relevant, the day, in that order; 

(ix)  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;  

(x) 

Where relevant, an indication of the net quantity of contents, expressed in terms of 
weight  or  volume,  numerical  count,  or  any  combination  of  these,  or  other  terms 
which accurately reflect the contents of the package; 

(xi) 

An indication of any special storage and/or handling condition that applies;  

(xii)  Where appropriate, an indication of the sterile state of the device and the sterilisation 
method,  or  a  statement  indicating  any  special  microbiological  state  or  state  of 
cleanliness; 

(xiii)  Warnings  or  precautions  to  be  taken  that  need  to  be  brought  to  the  immediate 
attention  of  the  user,  professional  or  lay,  or  other  person.  This  information  may  be 

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kept  to  a  minimum  in  which  case  more  detailed  information  shall  appear  in  the 
instructions for use;  

(xiv)  Where applicable, any particular operating instructions; 

(xv) 

(xvi) 

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 intended for self-testing or near-patient testing, an indication of that 
fact; 

(xvii) 

If the device is for performance evaluation only, an indication of that fact; 

(xviii)  Where  device  kits  include  individual  reagents  and  articles  that  may  be  made 
available as separate devices, each of these devices shall comply with the labelling 
requirements contained in this Section;  

(xix)  Wherever reasonable and practicable, the devices and separate components shall be 
identified,  where  appropriate  in  terms  of  batches,  to  allow  all  appropriate  action  to 
detect any potential risk posed by the devices and detachable components.  

17.3. 

Information in the instructions for use 

17.3.1.  The instructions for use shall contain the following particulars: 

(i) 

(ii) 

The name or trade name of the device; 

The device’s intended purpose:  

– 

– 

– 

– 

– 

– 

– 

what is detected and/or measured;  

its function (e.g. screening, monitoring, diagnosis or aid to diagnosis);  

the  specific  disorder,  condition  or  risk  factor  of  interest  that  it  is  intended  to 
detect, define or differentiate;  

whether it is automated or not; 

whether it is qualitative, semi-quantitative or quantitative; 

the type of specimen(s) required; and  

where applicable, the testing population. 

(iii) 

(iv) 

(v) 

(vi) 

An indication that the device is for in vitro diagnostic use; 

The intended user, as appropriate (e.g. healthcare professionals, lay person); 

The test principle; 

A description of the reagents, calibrators and controls and any limitation upon their 
use (e.g. suitable for a dedicated instrument only); 

(vii) 

A list of materials provided and a list of special materials required but not provided; 

(viii) 

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. 

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(ix) 

(x) 

(xi) 

(xii) 

An  indication  of  any  special  storage  (e.g.  temperature,  light,  humidity,  etc.)  and/or 
handling conditions which apply; 

In-use stability which may include the storage conditions, and shelf life following the 
first  opening  of  the  primary  container,  together  with  the  storage  conditions  and 
stability of working solutions, where this is relevant; 

If  the  device  is  supplied  as  sterile,  an  indication  of  its  sterile  state,  the  sterilisation 
method and instructions in the event of the sterile packaging being damaged before 
use; 

Information  that  allows  the  user  to  be  informed  of  any  warnings,  precautions, 
measures  to  be  taken  and  limitations  of  use  regarding  the  device.  This  information 
shall cover, where appropriate:  

– 

– 

– 

– 

– 

– 

warnings, precautions and/or measures to be taken in the event of malfunction 
of the device or its degradation as suggested by changes in its appearance that 
may affect performance;  

warnings, precautions and/or measures to be taken in regards to the exposure to 
reasonably  foreseeable  external  influences  or  environmental  conditions,  such 
as magnetic fields, external electrical and electromagnetic effects, electrostatic 
discharge,  radiation  associated  with  diagnostic  or  therapeutic  procedures, 
pressure, humidity, or temperature;  

warnings,  precautions  and/or  measures  to  be  taken  in  regards  to  the  risks  of 
interference posed by the reasonably foreseeable presence of the device during 
specific  diagnostic  investigations,  evaluations,  therapeutic  treatment  or  other 
procedures  (e.g.  electromagnetic  interference  emitted  by  the  device  affecting 
other equipment);  

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; 

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  reusable,  information  on  the  appropriate  processes  to  allow 
reuse, including cleaning, disinfection, decontamination, packaging and, where 
appropriate,  the  validated  method  of  re-sterilization.  Information  shall  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. 

(xiii)  Any  warnings  and/or  precautions  related  to  potentially  infectious  material  that  is 

included in the device; 

(xiv)  Where relevant, requirements for special facilities (e.g. clean room environment) or 
special  training  (e.g.  radiation  safety),  or  particular  qualifications  of  the  device 
intended user; 

(xv) 

Conditions for collection, handling, and preparation of the specimen; 

(xvi)  Details of any preparatory treatment or handling of the device before it is ready for 

use (e.g. sterilisation, final assembly, calibration, etc.); 

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(xvii)  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, 
including cleaning and 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 mitigating the risks encountered by persons involved in installing, 
calibrating or servicing devices. 

(xviii)  Where relevant, recommendations for quality control procedures; 

(xix) 

The  metrological  traceability  of  values  assigned  to  calibrators  and  trueness-control 
materials, including identification of applicable reference materials and/or reference 
measurement procedures of higher order; 

(xx) 

Assay  procedure  including  calculations  and  interpretation  of  results  and  where 
relevant if any confirmatory testing shall be considered; 

(xxi)  Analytical performance characteristics, such as sensitivity, specificity, and accuracy, 
repeatability,  reproducibility,  limits  of  detection  and  measurement  range,  including 
information needed for the control of known relevant interferences, limitations of the 
method  and  information  about  the  use  of  available  reference  measurement 
procedures and materials by the user; 

(xxii)  Where  relevant,  clinical  performance  characteristics,  such  as  diagnostic  sensitivity 

and diagnostic specificity; 

(xxiii)  Where relevant, reference intervals; 

(xxiv) 

Information  on  interfering  substances  or  limitations  (e.g.  visual  evidence  of 
hyperlipidaemia or haemolysis, age of specimen) that may affect the performance of 
the device; 

(xxv)  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 
shall cover, where appropriate:  

– 

– 

– 

infection or microbial hazards (e.g. consumables contaminated with potentially 
infectious substances of human origin);  

environmental  hazards  (e.g.  batteries  or  materials  that  emit  potentially 
hazardous levels of radiation);  

physical hazards (e.g. explosion). 

(xxvi)  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, together with a telephone number and/or fax number and/or 
website address to obtain technical assistance;  

(xxvii)  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; 

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(xxviii)  A notice to the user, professional or lay, 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; 

(xxix) Where device kits include individual reagents and articles that may be made available 
as separate devices, each of these devices shall comply with the instructions for use 
requirements contained in this Section.  

17.3.2.  In  addition,  the  instructions  for  use  for  devices  intended  for  self-testing  or  near-

patient testing shall comply with the following principles: 

(i) 

(ii) 

(iii) 

(iv) 

(v) 

Details  of  the  test  procedure  shall  be  given,  including  any  reagent  preparation, 
specimen  collection  and/or  preparation  and  information  on  how  to  run  the  test  and 
read the results;  

The results need to be expressed and presented in a way that is readily understood by 
the intended user;  

Information  needs  to  be  provided  with  advice  to  the  user  on  action  to  be  taken  (in 
case of positive, negative or indeterminate result), on the test limitations and on the 
possibility  of  false  positive  or  false  negative  result.  Information  shall  also  be 
provided  as  to  any  factors  that  can  affect  the  test  result  (e.g.  age,  gender, 
menstruation, infection, exercise, fasting, diet or medication); 

for  devices  intended  for  self-testing,  the  information  provided  shall  include  a 
statement  clearly  directing  that  the  user  should  not  take  any  decision  of  medical 
relevance without first consulting the appropriate healthcare professional; 

for  devices  intended  for  self-testing  used  for  the  monitoring  of  an  existing  disease, 
the information shall specify that the patient should only adapt the treatment if he has 
received the appropriate training to do so. 

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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 22(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 purpose of the device which may include:  

(i)  what is detected and/or measured; 

(ii) 

its function (e.g. screening, monitoring, diagnosis or aid to diagnosis);  

(iii) 

the specific disorder, condition or risk factor of interest that it is intended 
to detect, define or differentiate;  

(iv)  whether it is automated or not;  

(v)  whether it is qualitative, semi-quantitative or quantitative;  

(vi) 

the type of specimen(s) required;  

(vii)  where applicable, the testing population;  

(viii)  the intended user. 

(d) 

(e) 

(f) 

the description of the principle of the assay method or instrument principles of 
operation;  

the  risk  class  of  the  device  and  the  applicable  classification  rule  according  to 
Annex VII;  

the description of the components and where appropriate, the description of the 
reactive  ingredients  of  relevant  components  (such  as  antibodies,  antigens, 
nucleic acid primers); 

and where applicable:  

(g) 

(h) 

(i) 

the  description  of  the  specimen  collection  and  transport  materials  provided 
with the device or descriptions of specifications recommended for use;  

for  instruments  of  automated  assays:  the  description  of  the  appropriate  assay 
characteristics or dedicated assays;  

for  automated  assays:  a  description  of  the  appropriate  instrumentation 
characteristics or dedicated instrumentation;  

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(j) 

(k) 

(l) 

a description of any software to be used with the device;  

a  description  or  complete  list  of  the  various  configurations/variants  of  the 
device that will be made available;  

a description of the accessories, other in vitro diagnostic medical devices and 
other products, which are intended to be used in combination with the device.  

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  

– 

– 

(b) 

the label(s) on the device and on its packaging; 

the instructions for use; 

a  list  of  the  language  variants  for  the  Member  States  where  the  device  is 
envisaged to be marketed.  

3. 

DESIGN AND MANUFACTURING INFORMATION 

3.1. 

Design information 

Information to allow a general understanding of the design stages applied to the device.  

This shall include: 

(a) 

(b) 

(c) 

(d) 

(e) 

the  description  of  the  critical  ingredients  of  the  device  such  as  antibodies, 
antigens, enzymes and nucleic acid primers provided or recommended for use 
with the device;  

for  instruments,  the  description  of  major  subsystems,  analytical  technology 
(e.g.  operating principles, control mechanisms), dedicated  computer  hardware 
and software;  

for instruments and software, the overview of the entire system;  

for standalone software, the description of the data interpretation methodology 
(i.e. algorithm);  

for  devices  intended  for  self-testing  or  near-patient  testing  devices  the 
description  of  the  design  aspects  that  make  them  suitable  for  self-testing  or 
near-patient testing.  

3.2.  Manufacturing information 

(a) 

Information  to  allow  a  general  understanding  of  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;  

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(b) 

identification  of  all  sites,  including  suppliers  and  sub-contractors,  where 
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) 

(c) 

(d) 

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;  

the harmonised standards or CTS applied or other method(s) employed; 

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. 
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) 

(b) 

the risk/benefit analysis referred to in Section 1 and 5 of Annex I; and  

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.  

This includes:  

6.1 Information on analytical performance 

6.1.1 Specimen type  

This  section  shall  describe  the  different  specimen  types  that  can  be  used,  including  their 
stability (e.g. storage and where applicable transport conditions) and storage conditions (e.g. 
duration, temperature limits and freeze/thaw cycles).  

6.1.2 Analytical performance characteristics  

6.1.2.1 Accuracy of measurement  

(a)  Trueness of measurement 

This section shall provide information on the trueness of the measurement procedure 
and  summarise  the  data  in  sufficient  detail  to  allow  assessment  of  the  adequacy  of 
the  means  selected  to  establish  the  trueness.  Trueness  measures  apply  to  both 

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quantitative  and  qualitative  assays  only  when  a  reference  standard  or  method  is 
available. 

(b)  Precision of measurement 

This section shall describe repeatability and reproducibility studies. 

6.1.2.2 Analytical sensitivity 

This  section  shall  include  information  about  the  study  design  and  results.  It  shall  provide  a 
description of specimen type and preparation including matrix, analyte levels, and how levels 
were established. The number of replicates tested at each concentration shall also be provided 
as well as a description of the calculation used to determine assay sensitivity. 

6.1.2.3 Analytical specificity  

This section shall describe interference and cross reactivity studies to determine the analytical 
specificity in the presence of other substances/agents in the specimen. 

Information shall be provided on the  evaluation of potentially interfering and cross  reacting 
substances/agents  on  the  assay,  on  the  substance/agent  type  and  concentration  tested, 
specimen type, analyte test concentration, and results. 

Interferents and cross reacting substances/agents, which vary greatly depending on the assay 
type and design, could derive from exogenous or endogenous sources such as: 

(a) 

(b) 

(c) 

(d) 

(e) 

substances used for patient treatment (e.g. medicinal products); 

substances ingested by the patient (e.g. alcohol, foods); 

substances added during specimen preparation (e.g. preservatives, stabilisers); 

substances  encountered  in  specific  specimens  types  (e.g.  haemoglobin,  lipids, 
bilirubin, proteins); 

analytes  of  similar  structure  (e.g.  precursors,  metabolites)  or  medical 
conditions unrelated to the test condition including specimens negative for the 
assay but positive for a condition that may mimic the test condition. 

6.1.2.4 Metrological traceability of calibrator and control material values 

6.1.2.5 Measuring range of the assay 

This  section  shall  include  information  on  the  measuring  range  (linear  and  non-linear 
measuring  systems)  including  the  limit  of  detection  and  describe  information  on  how  these 
were established.  

This information shall include a description of specimen type, number of specimen, number 
of replicates, and preparation including information on matrix, analyte levels and how levels 
were established. If applicable, a description of high dose hook effect and the data supporting 
the mitigation (e.g. dilution) steps shall be added. 

6.1.2.6 Definition of assay cut-off 

This  section  shall  provide  a  summary  of  analytical  data  with  a  description  of  the  study  design 
including methods for determining the assay cut-off, including:  

(a) 

the  population(s)  studied  (demographics  /  selection  /  inclusion  and  exclusion 
criteria / number of individuals included);  

(b)  method or mode of characterisation of specimens; and  

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(c) 

statistical  methods  e.g.  Receiver  Operator  Characteristic  (ROC)  to  generate 
results and if applicable, define grey-zone/equivocal zone.  

6.2 Information on clinical performance 

Where  applicable,  the  documentation  shall  contain  data  on  the  clinical  performance  of  the 
device. 

The  clinical  evidence  report  referred  to  in  Section  3  of  Annex  XII  shall  be  included  and/or 
fully referenced in the technical documentation. 

6.3 Stability (excluding specimen stability)  

This section shall describe claimed shelf life, in use stability and shipping stability studies.  

6.3.1 Claimed shelf life 

This section shall provide information on stability testing studies to support the claimed shelf 
life. Testing shall be performed on at least three different lots manufactured under conditions 
that are essentially equivalent to routine production  conditions (these lots  do not need to be 
consecutive lots). Accelerated studies or extrapolated data from real time data are acceptable 
for initial shelf life claim but need to be followed up with real time stability studies.  

Such detailed information shall describe:  

(a) 

the study report (including the protocol, number of lots, acceptance criteria and 
testing intervals);  

(b)  when accelerated studies have been performed in anticipation of the real time 

studies, the method used for accelerated studies;  

(c) 

the conclusions and claimed shelf life.  

6.3.2 In-use stability  

This section shall provide information on in-use stability studies for one lot reflecting actual 
routine use of the device (real or simulated). This may include open vial stability and/or, for 
automated instruments, on board stability.  

In  the  case  of  automated  instrumentation  if  calibration  stability  is  claimed,  supporting  data 
shall be included.  

Such detailed information shall describe:  

(a) 

the  study  report  (including  the  protocol,  acceptance  criteria  and  testing 
intervals);  

(b) 

the conclusions and claimed in-use stability.  

6.3.3 Shipping stability 

This section shall provide information on shipping stability studies for one lot to evaluate the 
tolerance of products to the anticipated shipping conditions.  

Shipping studies can be done under real and/or simulated conditions and shall include variable 
shipping conditions such as extreme heat and/or cold.  

Such information shall describe:  

(a) 

(b) 

(c) 

the study report (including the protocol, acceptance criteria);  

the method used for simulated conditions;  

the conclusion and recommended shipping conditions.  

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6.4 Software verification and validation  

The  documentation  shall  contain  evidence  of  the  validation  of  the  software,  as  used  in  the 
finished  device.  This  information  shall  typically  include  the  summary  results  of  all 
verification,  validation  and  testing  performed  in-house  and  as  applicable  in  an  actual  user 
environment  prior  to  final  release.  It  shall  also  address  all  of  the  different  hardware 
configurations and, where applicable, operating systems identified in the labelling.  

6.5 Additional information in specific cases 

(a) 

(b) 

(c) 

(d) 

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.  

In the case of devices containing tissues, cells and substances of animal, human 
or  microbial  origin,  information  on  the  origin  of  such  material  and  on  the 
conditions in which it was collected. 

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. 

If  the  device  is  to  be  connected  to  other  equipment  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 
equipment having regard to the characteristics specified by the manufacturer.  

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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  22(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 the rules set out in 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. 

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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. 

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ANNEX V 

INFORMATION TO BE SUBMITTED WITH THE REGISTRATION OF 
DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH 
ARTICLE 23  

AND 

DATA ELEMENTS OF THE UDI DEVICE IDENTIFIER IN 
ACCORDANCE WITH ARTICLE 22 

Part A 

Information to be submitted with the registration of devices in accordance with Article 
23 

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. 

12. 

13. 

14. 

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 18 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 B, C or D: Member States where the device is 
or shall be made available, 

in case of imported device: country of origin, 

presence of tissues, cells or substances of human origin (y/n), 

presence of tissues, cells or substances of animal origin (y/n),  

presence of cells or substances of microbial origin (y/n), 

risk class of the device according to the rules set out in Annex VII, 

where  applicable,  single  identification  number  of  the  interventional  clinical 
performance  study  and  other  clinical  performance  study  involving  risks  for  the 
subjects  of  the  study  conducted  in  relation  to  the  device  (or  link  to  the  clinical 
performance  study  registration 
the  electronic  system  regarding  clinical 
performance studies), 

in 

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, 

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15. 

16. 

in case of devices classified as class C or D, the summary of safety and performance, 

status  of  the  device  (on  the  market,  no  longer  manufactured,  withdrawn  from  the 
market, recalled), 

17. 

indication when the device is a 'new' device. 

A device shall be considered as 'new' if:  

(a) 

(b) 

there  has  been  no  such  device  continuously  available  on  the  Union  market 
during the previous three years for the relevant analyte or other parameter; 

the  procedure  involves  analytical  technology  not  continuously  used  in 
connection with a given analyte or other parameter on the Union market during 
the previous three years. 

18. 

Indication if the device is intended for self-testing or near-patient testing. 

Part B 

Data elements of the UDI device identifier in accordance with Article 22 

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. 

9. 

10. 

11. 

12. 

13. 

14. 

15. 

16. 

17. 

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, 

if applicable, device model, reference, or catalogue number, 

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), 

URL for additional information, e.g. electronic instructions for use (optional), 

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18. 

if applicable, critical warnings or contraindications. 

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MINIMUM REQUIREMENTS TO BE MET BY NOTIFIED BODIES 

ANNEX VI 

1. 

1.1. 

ORGANISATIONAL AND GENERAL REQUIREMENTS 

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  in  vitro  diagnostic  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 
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 

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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 shall 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. 

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. 

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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  in  vitro  diagnostic 
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. 

2.1. 

QUALITY MANAGEMENT REQUIREMENTS 

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;  

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 

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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  in  vitro 
diagnostic  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 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  31,  providing  sufficient  level  of  detail  for  the  required 
qualification within the subdivisions of the scope description.  

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.  This  personnel  altogether  shall  have 
proven knowledge and experience in the following: 

– 

– 

– 

– 

– 

– 

– 

Union  in  vitro  diagnostic  medical  devices  legislation  and  relevant  guidance 
documents; 

the conformity assessment procedures in accordance with this Regulation; 

a  broad  base  of  in  vitro  diagnostic  medical  device  technologies,  the  in  vitro 
diagnostic medical device industry and the design and manufacture of in vitro 
diagnostic 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  in  vitro 
diagnostic medical devices as well as the relevant qualification criteria; 

training  relevant  to  personnel  involved  in  conformity  assessment  activities  in 
relation to in vitro diagnostic medical devices; 

the  ability  to  draw  up  certificates,  records  and  reports  demonstrating  that  the 
conformity assessments have been appropriately carried out. 

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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; 

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,  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 in vitro 
diagnostic medical device standards and guidance documents; 

the  conformity  assessment 
appropriate  knowledge  and  experience  of 
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. 

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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  sciences  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 in vitro diagnostic 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 in vitro 
diagnostic medical device standards and guidance documents; 

appropriate  knowledge  of  quality  management  systems  and  related  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 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 this 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. 

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3.4. 

Subcontractors and external experts  

3.4.1.  Without prejudice to the limitations emanating from Section 3.2., the 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, 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.  

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. 

4.1. 

4.2. 

PROCESS REQUIREMENTS  

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  in  vitro  diagnostic 
medical 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, 

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– 

– 

– 

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 

1. 

1.1. 

1.2. 

1.3. 

1.4. 

1.5. 

1.6. 

1.7. 

IMPLEMENTING RULES FOR THE CLASSIFICATION RULES 

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. 

Standalone  software,  which  drives  a  device  or  influences  the  use  of  a  device,  falls 
automatically in the same class as the device. If standalone software is independent 
of any other device, it is classified in its own right.  

Calibrators intended to be used with a device shall be classified in the same class as 
the device.  

Standalone control materials with quantitative or qualitative assigned values intended 
for one specific analyte or multiple analytes shall be classified in the same class as 
the device.  

The manufacturer shall take into consideration all the rules in order to establish the 
proper classification for the device.  

1.8.  Where  a  device  has  multiple  intended  purposes  stated  by  the  manufacturer,  which 

place the device into more than one class, it shall be classified in the higher class.  

1.9. 

If several classification rules apply to the same device the rule resulting in the higher 
classification shall apply. 

2. 

CLASSIFICATION RULES 

2.1. 

Rule 1 

Devices intended for the following purposes are classified as class D:  

– 

– 

Devices  intended  to  be  used  to  detect  the  presence  of,  or  exposure  to,  a 
transmissible agent in blood, blood components, cells, tissues or organs, or in 
any  of  their  derivatives,  in  order  to  assess  their  suitability  for  transfusion  or 
transplantation. 

Devices  intended  to  be  used  to  detect  the  presence  of,  or  exposure  to,  a 
transmissible  agent  that  causes  a  life-threatening  disease  with  a  high  or 
currently undefined risk of propagation. 

This rule applies to first line assays, confirmatory assays and supplemental assays. 

2.2. 

Rule 2 

Devices intended to be used for blood grouping, or tissue typing to ensure the immunological 
compatibility  of  blood,  blood  components,  cells,  tissue  or  organs  that  are  intended  for 
transfusion  or  transplantation,  are  classified  as  class  C,  except  when  intended  to  determine 
any of the following markers: 

– 

ABO system [A (ABO1), B (ABO2), AB (ABO3)]; 

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– 

– 

– 

– 

Rhesus system [RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e)]; 

Kell system [Kel1 (K)]; 

Kidd system [JK1 (Jka), JK2 (Jkb)]; 

Duffy system [FY1 (Fya), FY2 (Fyb)]  

in which case they are classified as class D. 

2.3. 

Rule 3 

Devices are classified as class C if they are intended for:  

(a)  detecting the presence of, or exposure to, a sexually transmitted agent; 

(b)  detecting  the  presence  in  cerebrospinal  fluid  or  blood  of  an  infectious  agent 

with a risk of limited propagation;  

(c)  detecting the presence of an infectious agent, if there is a significant risk that 
an erroneous result would cause death or severe disability to the individual or 
foetus being tested, or to the individual's offspring;  

(d)  pre-natal  screening  of  women  in  order  to  determine  their  immune  status 

towards transmissible agents; 

(e)  determining infective disease status or immune status, if there is a risk that an 
erroneous  result  would  lead  to  a  patient  management  decision  resulting  in  an 
imminent life-threatening situation for the patient or for the patient's offspring; 

(f) 

selection of patients, i.e. 

(i)  Devices intended to be used as companion diagnostics; or 

(ii)  Devices intended to be used for disease staging; or 

(iii)  Devices  intended  to  be  used  in  screening  for  or  in  the  diagnosis  of 

cancer. 

(g)  human genetic testing; 

(h)  monitoring  of 

levels  of  medicinal  products,  substances  or  biological 
components, when there is a risk that an erroneous result will lead to a patient 
management decision resulting in an imminent life-threatening situation for the 
patient or for the patient's offspring; 

(i)  management of patients suffering from a life-threatening infectious disease;  

(j) 

screening for congenital disorders in the foetus.  

2.4. 

Rule 4 

(a)  Devices intended for self-testing are classified as class C, except those devices 
from  which  the  result  is  not  determining  a  medically  critical  status,  or  is 
preliminary  and  requires  follow-up  with  the  appropriate  laboratory  test  in 
which case they are Class B.  

(b)  Devices  intended  for  blood  gases  and  blood  glucose  determinations  for  near-
patient  testing  are  class  C.  Other  devices  that  are  intended  for  near-patient 
testing shall be classified in their own right. 

2.5. 

Rule 5 

The following devices are classified as class A: 

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(a) 

reagents or other articles which possess specific characteristics, intended by the 
manufacturer to make them suitable for in vitro diagnostic procedures related 
to a specific examination; 

(b) 

instruments  intended  by  the  manufacturer  specifically  to  be  used  for  in  vitro 
diagnostic procedures;  

(c) 

specimen receptacles. 

2.6. 

Rule 6 

Devices not covered by the above-mentioned classification rules are classified as class B. 

2.7. 

Rule 7 

Devices which are controls without a quantitative or qualitative assigned value are classified 
as class B. 

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ANNEX VIII 

CONFORMITY ASSESSMENT BASED ON FULL QUALITY 
ASSURANCE AND DESIGN EXAMINATION  

1. 

2. 

3. 

3.1. 

Chapter I: Full Quality Assurance System 

The  manufacturer  shall  ensure  application  of  the  quality  management  system 
approved for the design, manufacture and final inspection of the devices 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 15 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. 

Quality management system 

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  an  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  follow-up,  and  the  procedures  put  in 
place to ensure compliance with the obligations emanating from the provisions 
on vigilance set out in Articles 59 to 64, 

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 
follow-up,  and  the  procedures  ensuring  compliance  with  the  obligations 
emanating from the provisions on vigilance set out in Articles 59 to 64, as well 
as the undertaking by the manufacturer to apply these procedures. 

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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) 

(b) 

– 

– 

– 

– 

(c) 

the manufacturer's quality objectives; 

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;  

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: 

– 

– 

(e) 

the  processes  and  procedures  which  will  be  used,  particularly  as  regards 
sterilisation, purchasing and the relevant documents, 

the  product  identification  procedures  drawn  up  and  kept  up  to  date  from 
drawings,  specifications  or  other  relevant  documents  at  every  stage  of 
manufacture; 

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 system to determine whether it meets 
the requirements referred to in Section 3.2. Unless duly substantiated, it shall 

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that  quality  management  systems  which  satisfy 

presume 
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 classified as class C, 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  purpose  and  the  results 
of any previous relevant assessments 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. 

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. 

Surveillance assessment applicable to devices classified as class C and D 

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  follow-up,  as  well  as,  if  applicable,  any  findings  resulting  from  the 
application  of  the  post-market  surveillance  plan,  including  the  post-market 
follow-up, and of the provisions on vigilance set out in Articles 59 to 64, 

the  data  stipulated  in  the  part  of  the  quality  management  system  relating  to 
design,  such  as  the  results  of  analyses,  calculations,  tests  and  the  solutions 
adopted regarding the risk-management as referred to in Section 2 of Annex I, 

3.4. 

4. 

4.1. 

4.2. 

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4.3. 

4.4. 

– 

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 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 
manufacturer  and, 
the  manufacturer's  suppliers  and/or 
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 shall 
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 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. 

4.6. 

4.7. 

the  assessment  of 

In  the  case  of  devices  classified  as  class  C,  the  surveillance  assessment  shall  also 
include 
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.  

the  design  documentation  within 

the 

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 

5. 

Examination  of  the  design  of  the  device  and  batch  verification  applicable  to 
devices in class D  

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5.1. 

5.2. 

5.3. 

5.4. 

In  addition  to  the  obligation  imposed  by  Section  3,  the  manufacturer  of  devices 
classified as class D shall lodge with the notified body referred to in Section 3.1 an 
application for the 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.  

In the case of devices for self-testing or near-patient testing, the application shall also 
include the aspects referred to in Section 6.1, point b). 

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  this  Regulation.  The 
notified body shall carry out adequate physical or laboratory tests in relation to the 
device or request the manufacturer to carry out such tests.  

Before issuing an EU design-examination certificate, the notified body shall request 
a  reference  laboratory,  where  designated  in  accordance  with  Article  78,  to  verify 
compliance  of  the  device  with  the  CTS,  when  available,  or  with  other  solutions 
chosen  by  the  manufacturer  to  ensure  a  level  of  safety  and  performance  that  is  at 
least equivalent. 

The reference laboratory shall provide a scientific opinion within 30 days.  

The scientific opinion of the reference laboratory and any possible updates 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.  

5.5. 

The  notified  body  shall  provide  the  manufacturer  with  an  EU  design-examination 
report. 

5.6. 

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  this 
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.  

Where  the  changes  could  affect  compliance  with  the  CTS  or  with  other  solutions 
chosen  by  the  manufacturer  which  were  approved  through  the  EU  design-

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5.7. 

5.8. 

6. 

6.1. 

examination certificate, the notified body shall consult the reference laboratory that 
was involved in the initial consultation, in order to confirm that compliance with the 
CTS or with other solutions chosen by the manufacturer to ensure a level of safety 
and performance that is at least equivalent are maintained. 

The reference laboratory shall provide a scientific opinion within 30 days.  

The  approval  of  any  change  to  the  approved  design  shall  take  the  form  of  a 
supplement to the EU design-examination certificate.  

To verify conformity of manufactured devices classified as class D, the manufacturer 
shall carry out tests on the manufactured devices or each batch of devices. After the 
conclusion  of  the  controls  and  tests  he  shall  forward  to  the  notified  body  without 
delay  the  relevant  reports  on  these  tests.  Furthermore,  the  manufacturer  shall  make 
the samples of manufactured devices or batches of devices available to the notified 
body  in  accordance  with  pre-agreed  conditions  and  modalities  which  shall  include 
that the notified body or the manufacturer, in regular intervals, shall send samples of 
the  manufactured  devices  or  batches  of  devices  to  a  reference  laboratory,  where 
designated  in  accordance  with  Article  78,  to  carry  out  appropriate  tests.  The 
reference laboratory shall inform the notified body about its findings. 

The  manufacturer  may  place  the  devices  on  the  market,  unless  the  notified  body 
communicates  to  the  manufacturer  within  the  agreed  time-frame,  but  not  later  than 
30 days after reception of the samples, any other decision, including in particular any 
condition of validity of delivered certificates. 

Examination of the design of specific types of devices  

Examination  of  the  design  of  devices  for  self-testing  and  near-patient  testing 
classified as class A, B or C 

(a)  The manufacturer of devices for self-testing or near-patient testing classified as 
class A, B and C shall lodge with the notified body referred to in Section 3.1 an 
application for the examination of the design.  

(b)  The application shall enable the design of the device to be understood and shall 
enable conformity with the design-related requirements of this Regulation to be 
assessed. It shall include: 

– 

– 

– 

– 

test reports, including results of studies carried out with intended users; 

where  practicable,  an  example  of  the  device;  if  required,  the  device  shall  be 
returned on completion of the design examination; 

data  showing  the  handling  suitability  of  the  device  in  view  of  its  intended 
purpose for self-testing or near patient-testing; 

the information to be provided with the device on its label and its instructions 
for use. 

The  notified  body  may  require  the  application  to  be  completed  by  further  tests  or 
proof to allow assessment of conformity with the requirements of this Regulation.  

(c)  The  notified  body  shall  examine  the  application  employing  staff  with  proven 
knowledge and experience regarding the technology concerned and provide the 
manufacturer with an EU design-examination report.  

(d) 

If  the  device  conforms  to  the  relevant  provisions  of  this  Regulation,  the 
notified body shall issue an EU design-examination certificate. The certificate 

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shall contain the conclusions of the examination, the conditions of validity, the 
data  needed  for  the  identification  of  the  approved  design  and,  where 
appropriate, a description of the intended purpose of the device.  

(e)  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 this 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.  

6.2. 

Examination of the design of companion diagnostics  

(a)  The manufacturer of a companion diagnostic shall lodge with the notified body 
referred to in Section 3.1 an application for the examination of the design.  

(b)  The application shall enable the design of the device to be understood and shall 
enable conformity with the design-related requirements of this Regulation to be 
assessed, in particular, with regard to the suitability of the device in relation to 
the medicinal product concerned.  

(c)  For companion diagnostic intended to be used to assess the patient eligibility to 
a  treatment  with  a  specific  medicinal  product,  the  notified  body  shall  consult 
before  issuing  an  EU  design-examination  certificate  and  on  the  basis  of  the 
draft summary of safety and performance and the draft instructions for use, 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’)  established  by  the  Regulation  (EC)  No  726/2004  laying  down 
Community  procedures  for  the  authorisation  and  supervision  of  medicinal 
products for human and veterinary use and establishing a European Medicines 
Agency43,  regarding  the  suitability  of  the  device  in  relation  to  the  medicinal 
product  concerned.  Where  the  medicinal  product  falls  exclusively  within  the 
scope  of  the  Annex  of  Regulation  (EC)  No  726/2004,  the  notified  body  shall 
consult the EMA.  

(d)  The medicinal products competent authority or the EMA shall give its opinion, 
if any, within 60 days after receipt of valid documentation. This 60-day period 
may  be  extended  only  once  for  a  further  60  days  on  scientifically  valid 
grounds. The opinion  of  the  medicinal products authority or  of the  EMA  and 
any possible update shall be included in the documentation of the notified body 
concerning the device.  

(e)  The notified body shall give due consideration to the opinion, if any, expressed 
by  the  medicinal  products  competent  authority  concerned  or  the  EMA  when 
making its decision. It shall convey its final decision to the medicinal products 
competent  authority  concerned  or  to  the  EMA.  The  design-examination 
certificate shall be delivered in accordance with point (d) of Section 6.1. 

43 

OJ L 136, 30.4.2004, p. 1 

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(f)  Before  changes  affecting  the  suitability  of  the  device  in  relation  to  the 
medicinal  product  concerned  are  made,  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 or the EMA. 
The medicinal products competent authority or the EMA shall give its opinion, 
if  any,  within  30  days  after  receipt  of  the  valid  documentation  regarding  the 
changes. A supplement to the EU design-examination certificate shall be issued 
in accordance with point (e) of Section 6.1. 

Chapter III: Administrative provisions 

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  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 Sections 5.2 and point (b) of Section 6.1, and 

the decisions and reports from the notified body as referred to in Sections 3.3, 
4.3, 4.4, 5.5, 5.6, 5.8, points (c), (d) and (e) of Section 6.1, point (e) of Section 
6.2 and point (f) of Section 6.2. 

8. 

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 ASSESSMENT 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, 

in  the  case  of  devices  for  self-testing  or  near-patient  testing,  test  reports, 
including results of studies carried out  with  intended  users, and data showing 
the handling suitability of the device in view of its intended purpose for self-
testing or near patient-testing,  

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  equipment  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 equipment 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. 

3.5. 

3.6. 

agree with the applicant on the place where the necessary assessments and tests will 
be carried out; 

in  the  case  of  devices  classified  as  class  D,  request  a  reference  laboratory,  where 
designated in accordance with Article 78, to verify compliance of the device with the 
CTS or with other solutions chosen by the manufacturer to ensure a level of safety 
and performance that is at least equivalent. The reference laboratory shall provide a 
scientific opinion within 30 days. The scientific opinion of the reference laboratory 
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; 

For  companion  diagnostic  intended  to  be  used  to  assess  the  patient  eligibility  to  a 
treatment  with  a  specific  medicinal  product,  seek  the  opinion,  on  the  basis  of  the 
draft summary of safety and performance and the draft instructions for use, of a 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’) on 
the suitability of the device in relation to the medicinal product concerned. Where the 
medicinal product falls exclusively within the scope of the Annex of Regulation (EC) 
No  726/2004,  the  notified  body  shall  consult  the  EMA.  The  medicinal  products 
authority or the European Medicines Agency shall deliver its opinion, if any, within 
60  days  upon  receipt  of  the  valid  documentation.  This  60-day  period  may  be 
extended only once for a further 60 days on scientifically valid grounds. The opinion 
of the medicinal products authority or of 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  opinion,  if  any,  expressed  by  the 
medicinal  products  competent  authority  concerned  or  the  EMA  when  making  its 
decision.  It  shall  convey  its  final  decision  to  the  medicinal  products  competent 
authority concerned or to the EMA.  

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. 

5.1. 

5.2. 

Changes to the type 

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.  

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5.3.  Where  the  changes  could  affect  compliance  with  the  CTS  or  with  other  solutions 
chosen by the manufacturer which were approved through the EU type-examination 
certificate, the notified body shall consult the reference laboratory that was involved 
in  the  initial  consultation,  in  order  to  confirm  that  compliance  with  the  CTS,  when 
available,  or  with  other  solutions  chosen  by  the  manufacturer  to  ensure  a  level  of 
safety and performance that is at least equivalent are maintained. 

The reference laboratory shall provide a scientific opinion within 30 days. 

5.4.  Where  the  changes  affect  a  companion  diagnostic  approved  through  the  EU  type-
examination  certificate  with  regard  to  its  suitability  in  relation  to  a  medicinal 
product, the notified body shall consult the medicinal products competent authority 
that  was  involved  in  the  initial  consultation  or  the  EMA.  The  medicinal  products 
competent authority or the EMA shall give its opinion, if any, within 30 days after 
receipt  of  the  valid  documentation  regarding  the  changes.  The  approval  of  any 
change  to  the  approved  type  shall  take  the  form  of  a  supplement  to  the  initial  EU 
type-examination certificate. 

6. 

Administrative provisions 

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 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 8 of Annex VIII shall apply. 

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CONFORMITY ASSESSMENT BASED ON PRODUCTION QUALITY 
ASSURANCE  

ANNEX X 

1. 

2. 

3. 

3.1. 

3.2. 

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 15 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. 

Quality management system 

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.  

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 system ensures that the devices conform to the type described in the 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 the Section 3.4 of Annex VIII apply.  

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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. 

5. 

5.1. 

Verification of manufactured devices classified as class D 

In the case of devices classified as class D, the manufacturer shall carry out tests on 
the  manufactured  devices  or  each  batch  of  devices.  After  the  conclusion  of  the 
controls  and  tests  he  shall  forward  to  the  notified  body  without  delay  the  relevant 
reports  on  these  tests.  Furthermore,  the  manufacturer  shall  make  the  samples  of 
manufactured  devices  or  batches  of  devices  available  to  the  notified  body  in 
accordance  with  pre-agreed  conditions  and  modalities  which  shall  include  that  the 
notified  body  or  the  manufacturer,  in  regular  intervals,  shall  send  samples  of  the 
manufactured  devices  or  batches  of  devices  to  a  reference  laboratory,  where 
designated  in  accordance  with  Article  78,  to  carry  out  appropriate  tests.  The 
reference laboratory shall inform the notified body about its findings 

5.2. 

The  manufacturer  may  place  the  devices  on  the  market,  unless  the  notified  body 
communicates  to  the  manufacturer  within  the  agreed  time-frame,  but  not  later  than 
30 days after reception of the samples, any other decision, including in particular any 
condition of validity of delivered certificates. 

6. 

Administrative provisions 

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 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 8 of Annex VIII shall apply. 

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MINIMUM CONTENT OF CERTIFICATES ISSUED BY A NOTIFIED 
BODY 

ANNEX XI 

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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CLINICAL EVIDENCE AND POST-MARKET FOLLOW-UP 

ANNEX XII 

Part A: Clinical evidence  

The  demonstration  of  conformity  with  the  general  safety  and  performance  requirements  set 
out in Annex I, under the normal conditions of use of the device, shall be based on clinical 
evidence.  

The  clinical  evidence  includes  all  the  information  supporting  the  scientific  validity  of  the 
analyte,  the  analytical  performance  and,  where  applicable,  the  clinical  performance  of  the 
device for its intended purpose as stated by the manufacturer. 

1. 

1.1. 

SCIENTIFIC VALIDITY DETERMINATION AND PERFORMANCE EVALUATION 

Scientific validity determination 

1.1.1.  The scientific validity refers to the association of the analyte to a clinical condition or 

a physiological state. 

1.1.2.  The  determination  of  the  scientific  validity  may  not  be  necessary  where  the 
association  of  the  analyte  to  a  clinical  condition  or  a  physiological  state  is  well 
known,  based  on  available  information,  such  as  peer  reviewed  literature,  historical 
data and experience. 

1.1.3.  For  a  new  analyte  and/or  a  new  intended  purpose,  the  scientific  validity  shall  be 

demonstrated based on one or a combination of the following sources: 

– 

– 

– 

– 

– 

information  on  devices  measuring  the  same  analyte  with  the  same  intended 
purpose that have marketing history; 

literature; 

expert opinions; 

results from proof of concept studies; 

results from clinical performance studies. 

1.1.4.  The information supporting the scientific validity of the analyte shall be summarised 

as part of the clinical evidence report. 

1.2. 

Performance evaluation  

The performance evaluation of a device is the process by which generated data are assessed 
and  analysed  to  demonstrate  the  analytical  performance,  and  where  applicable  the  clinical 
performance of that device for its intended purpose as stated by the manufacturer. 

Interventional performance studies and other clinical performance studies involving risks for 
the  subjects  of  the  studies  shall  only  be  performed  once  the  analytical  performance  of  the 
device has been established and determined to be acceptable.  

1.2.1.  Analytical performance  

1.2.1.1 The analytical performance characteristics are described in point (a) of Section 6(1) of 
Annex I.  

1.2.1.2  As  a  general  rule,  the  analytical  performance  shall  always  be  demonstrated  on  the 
basis of analytical performance studies.  

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1.2.1.3 For novel devices, it may not be possible to demonstrate trueness since suitable higher 
order reference materials or a suitable comparative method may not be available. If there are 
no  comparative  methods,  different  approaches  may  be  used  (e.g.  comparison  to  some  other 
well-documented method, comparison to the composite reference method). In the absence of 
such  approaches,  a  clinical  performance  study  comparing  test  performance  to  the  current 
clinical standard practice would be needed. 

1.2.1.4 The analytical performance data shall be summarised as part of the clinical evidence 
report.  

1.2.2.  Clinical performance 

1.2.2.1 The clinical performance characteristics are described in point (b) of Section 6(1) of 
Annex I. 

1.2.2.2  Clinical  performance  data  may  not  be  required  for  established  and  standardised 
devices and for devices classified as class A according to the rules set out in Annex VII. 

1.2.2.3 Clinical performance of a device shall be demonstrated based on one or a combination 
of the following sources 

– 

– 

– 

clinical performance studies; 

literature; 

experience gained by routine diagnostic testing. 

1.2.2.4  Clinical  performance  studies  shall  be  performed  unless  it  is  duly  justified  to  rely  on 
other sources of clinical performance data. 

1.2.2.5 Clinical performance data shall be summarised as part of the clinical evidence report. 

1.2.2.6  When  the  clinical  performance  evaluation includes a clinical performance  study, the 
level  of  detail  of  the  clinical  performance  study  report  referred  to  in  Section  2.3.3  of  this 
Annex will vary based on the risk class of the device determined according to the rules set out 
in Annex VII:  

– 

– 

– 

For  devices  classified  as  class  B  according  to  the  rules  set  out  in  Annex  VII, 
the clinical performance study report may be limited to a summary of the study 
protocol, results and conclusion; 

For  devices  classified  as  class  C  according  to  the  rules  set  out  in  Annex  VII, 
the clinical performance study report shall include the method of data analysis, 
the study conclusion and the relevant details of the study protocol; 

For devices classified as class D according to the rules set out in Annex VII, 
the clinical performance study report shall include the method of data analysis, 
the  study  conclusion,  the  relevant  details  of  the  study  protocol  and  the 
individual data points.  

2. 

2.1. 

CLINICAL PERFORMANCE STUDIES 

Purpose of clinical performance studies  

The  purpose  of  clinical  performance  studies  is  to  establish  or  confirm  aspects  of  device 
performance which cannot be determined by analytical performance studies, literature and/or 
previous  experience  gained  by  routine  diagnostic  testing.  This  information  is  used  to 
demonstrate compliance with the relevant general safety and performance requirements with 
respect  to  clinical  performance.  When  clinical  performance  studies  are  conducted,  the  data 

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obtained  shall  be  used  in  the  performance  evaluation  process  and  be  part  of  the  clinical 
evidence for the device. 

2.2. 

Ethical considerations for clinical performance studies 

Every  step  in  the  clinical  performance  study,  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 Assembly in Helsinki, Finland, in 1964 
and last amended by the 59th World Medical Association General Assembly in Seoul, Korea, 
in 2008.  

2.3.  Methods for clinical performance studies 

2.3.1.  Clinical performance study design type 

Clinical performance studies shall be designed in such a way as to maximize the relevance of 
the  data  while  minimising  potential  biases.  The  design  of  the  study  shall  provide  the  data 
necessary to address the clinical performance of the device. 

2.3.2.  Clinical performance study protocol 

Clinical  performance  studies  shall  be  performed  on  the  basis  of  an  appropriate  'clinical 
performance study protocol'.  

The  clinical  performance  study  protocol  shall  set  out  how  the  study  is  intended  to  be 
conducted. It shall contain information about the study design such as the purpose, objectives, 
study population, description of test method(s) and interpretation of results, site training and 
monitoring, specimen type, specimen collection, preparation, handling and storage, inclusion 
and exclusion criteria, limitations, warning and precautions, data collection/management, data 
if  applicable,  clinical 
analysis, 
endpoints/outcomes, and requirements for patient follow-up. 

required  materials,  number  of  study  sites  and 

In addition, the clinical performance study protocol shall identify the key factors which may 
impact  the  completeness  and  significance  of  results,  such  as  intended  participant  follow-up 
procedures,  decision  algorithms,  discrepancy 
resolution  process,  masking/blinding, 
approaches to statistical analyses, and methods for recording endpoints/outcomes and, where 
appropriate, communication of test results. 

2.3.3.  Clinical performance study report 

A 'clinical performance study report', signed by a medical practitioner or any other authorised 
person responsible, shall  contain documented information  on the  clinical performance  study 
protocol,  results  and  conclusions  of  the  clinical  performance  study,  including  negative 
findings. The results and conclusions shall be transparent, free of bias and clinically relevant. 
The report shall contain sufficient information to enable it to be understood by an independent 
party without reference to other documents. The report shall also include as appropriate any 
protocol amendments or deviations, and data exclusions with the appropriate rationale. 

3. 

CLINICAL EVIDENCE REPORT 

3.1  The  clinical  evidence  report  shall  contain  the  scientific  validity  data,  the  analytical 
performance  data  and,  where  applicable,  the  clinical  performance  data.  If  the  analytical 
performance data is determined to be sufficient to declare conformity with the general safety and 

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performance requirements set out to in Annex I without the need for clinical performance data, 
a rationale should be documented and included in the clinical evidence report. 

3.2 The clinical evidence report shall in particular outline: 

– 

– 

– 

– 

– 

the justification for the approach taken to gather the clinical evidence;  

the technology on which the device is based, the intended purpose of the device 
and any claims made about the device’s clinical performance or safety;  

the nature and extent of the scientific validity and the performance data that has 
been evaluated;  

how  the  referenced  information  demonstrate  the  clinical  performance  and 
safety of the device in question;  

the literature search methodology, if a literature review is the approach taken to 
gathering clinical evidence. 

3.3 The clinical evidence 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(5) which shall include a plan for the device 
post-market follow-up in accordance with Part B of this Annex.  

1. 

2. 

3. 

4. 

Part B: Post-market follow-up 

Manufacturers  shall  put  in  place  procedures  to  enable  them  to  collect  and  evaluate 
information  relating  to  the  scientific  validity,  as  well  as  the  analytical  and  clinical 
performance of their devices on the basis of data obtained from post-market follow-
up.  

Where such information becomes available to the manufacturer, an appropriate risk 
assessment  shall  be  conducted  and  the  clinical  evidence  report  shall  be  amended 
accordingly. 

Where changes to devices are necessary, the conclusion of the post market follow-up 
shall  be  taken  into  account  for  the  clinical  evidence  referred  to  in  Part  A  of  this 
Annex and for the risk assessment referred to in Section 2 of Annex I. If necessary, 
the clinical evidence or risk management shall be updated and/or corrective actions 
be implemented. 

Any  new  intended  purpose  of  a  device  shall  be  supported  by  an  updated  clinical 
evidence report.  

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ANNEX XIII 

INTERVENTIONAL CLINICAL PERFORMANCE STUDIES AND 
OTHER CLINICAL PERFORMANCE STUDIES INVOLVING RISKS 
FOR THE SUBJECTS OF THE STUDIES 

I. 

Documentation 
clinical 
the  application 
performance  studies and  other  clinical performance studies involving risks for 
the subjects of the studies 

interventional 

regarding 

for 

For  devices  for  performance  evaluation  intended  to  be  used  in  the  context  of  interventional 
clinical  performance  studies  or  other  clinical  performance  studies  involving  risks  for  the 
subjects  of  the  studies  the  sponsor  shall  draw  up  and  submit  the  application  in  accordance 
with Article 49 accompanied by the documentation as laid down below:  

1. 

Application form 

The application form shall be duly filled out containing the following information:  

1.1.  Name,  address  and  contact  details  of  the  sponsor  and,  if  applicable,  name, 
address and contact details of his contact person established in the Union. 

1.2.  If  different  from  the  above,  name,  address  and  contact  details  of  the 
manufacturer  of  the  device  intended  for  performance  evaluation  and,  if 
applicable, of his authorised representative. 

1.3.  Title of the clinical performance study.  

1.4.  Single identification number in accordance with Article 49(1). 

1.5.  Status  of  the  clinical  performance  study  (e.g.  first  submission,  resubmission, 

significant amendment). 

1.6.  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. 

1.7.  If parallel submission for a clinical trial on a medicinal product in accordance 
with  Regulation  (EU)  No  [Ref.  of  future  Regulation  on  clinical  trials], 
reference to the official registration number of the clinical trial.  

1.8.  Identification  of  the  Member  States,  EFTA  countries,  Turkey  and  third 
countries in which the clinical performance study shall be conducted as part of 
a multicentre/ multinational study at the time of application.  

1.9.  Brief description of the device for performance evaluation (e.g. name, GMDN 
code  or  internationally  recognised  nomenclature  code,  intended  purpose,  risk 
class and applicable classification rule according to Annex VII). 

1.10  Summary of the clinical performance study protocol. 

1.11.  If applicable, information regarding a comparator. 

2. 

Investigator's Brochure  

The investigator's brochure (IB) shall contain the information on the device for performance 
evaluation  that  is  relevant  for  the  study  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. 

2.4.  Existing clinical data, in particular the following: 

– 

– 

relevant  scientific  literature  available  relating  to  the  safety,  performance, 
design characteristics and intended purpose of the device and/or of equivalent 
or similar devices; 

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. 

2.5.  Summary  of  the  risk/benefit  analysis  and  the  risk  management,  including 

information regarding known or foreseeable risks and warnings. 

2.6.  In  the  case  of  devices  that  include  tissues,  cells  and  substances  of  human, 
animal  or  microbial  origins  detailed  information  on  the  tissues,  cells  and 
substances,  and  on  the  compliance  with  the  relevant  general  safety  and 
performance requirements and the specific risk management in relation to the 
tissues, cells and substances.  

2.7.  Reference  to  harmonised  or  other  internationally  recognised  standards 

complied with in full or in part.  

2.8.  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. 

Clinical performance study protocol, as referred to in Section 2.3.2 of Annex XII.  

Other information 

4.1.  A  signed  statement  by  the  natural  or  legal  person  responsible  for  the 
manufacture  of  the  device  for  performance  evaluation  that  the  device  in 
question  conforms  to  the  general  safety  and  performance  requirements  apart 
from  the  aspects  covered  by  the  clinical  performance  study  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,  a  copy  of  the  opinion(s)  of  the 

ethics committee(s) concerned as soon as available. 

4.3.  Proof  of  insurance  cover  or  indemnification  of  subjects  in  case  of  injury, 

according to the national law 

4.4.  Documents and procedures to be used to obtain informed consent. 

4.5  Description  of  the  arrangements  to  comply  with  the  applicable  rules  on  the 

protection and confidentiality of personal data, in particular: 

3. 

4. 

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– 

– 

– 

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  performance 
studies; 

a  description  of  measures  that  will  be  implemented  in  case  of  data  security 
breach in order to mitigate the possible adverse effects. 

II. 

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 I 
of this Annex. If the sponsor is not the natural or legal person responsible for the manufacture 
of  the  device  intended  for  performance  evaluation,  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. 

3. The documentation mentioned in this Annex shall be kept for a period of time of at least 
five years after the clinical performance study 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.  

Each Member State shall make provision that this documentation is kept at the disposal of the 
competent authorities for the period indicated in 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 XIV 

CORRELATION TABLE 

Directive 98/79/EC 

This Regulation 

Article 1(1) 

Article 1(2) 

Article 1(3) 

Article 1(4) 

Article 1(5) 

Article 1(6) 

Article 1(7) 

Article 2 

Article 3 

Article 4(1) 

Article 4(2) 

Article 4(3) 

Article 4(4) 

Article 4(5) 

Article 5(1) 

Article 5(2) 

Article 5(3) 

Article 6 

Article 7 

Article 8 

Article 1(1) 

Article 2 

Number (36) of Article 2 

- 

Article 4(4) and (5) 

Article 1(6) 

Article 1(4) 

Article 4(1) 

Article 4(2) 

Article 20 

Article 17(1) 

Article 17(3) 

Article 8(7) 

Article 16(6) 

Article 6(1) 

- 

Article 7 

-  

Article 84 

Articles 67 to 70  

Article 9(1) 1st subparagraph 

Article 40(5) 1st subparagraph 

Article 9(1) 2nd subparagraph 

Article  40(3)  2nd  subparagraph  and  (4)  2nd 
subparagraph 

Article 9(2) 

Article 40(2) 

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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 9(11) 

Article 9(12) 

Article 9(13) 

Article 10 

Article 11(1) 

Article 11(2) 

Article 11(3) 

Article 11(4) 

Article 11(5) 

Article 12 

Article 13 

Article 14(1)(a) 

Article 14(1)(b) 

Article 14(2) 

Article 14(3) 

Article 15(1) 

Article 15(2) 

Article 40(3) 

Article 40(7) 

- 

Article 9(3) 

Article 8(4) 

Article 41(1) 

Article 41(3) 

Article 43(2) 

Article 40(8) 

Article 45(1) 

Article 5(2) 

Article 23 

Numbers  (43)  and  (44)  of  Article  2,  Article 
59(1) and Article 61(1) 

Article  59(3) 
subparagraph 

and  Article  61(1)  2nd 

Article 61(2) and (3) 

- 

Article 61(3) and Article 64 

Article 25 

Article 72 

Article 39(4) 

- 

- 

- 

Article 31 and Article 32 

Article 27 

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Article 15(3) 

Article 15(4) 

Article 15(5) 

Article 15(6) 

Article 15(7) 

Article 16 

Article 17 

Article 18 

Article 19 

Article 20 

Article 21 

Article 22 

Article 23 

Article 24 

Article 33(1) and Article 34(2) 

- 

Article 43(4) 

Article 43 (3) 

Articles 29(2) and Article 33(1) 

Article 16 

Article 71 

Article 73 

Article 80 

Article 75 

- 

- 

Article 90 

- 

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