COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
Date: 2017-03-09
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: genetics, marketing standard, medical device, medical diagnosis, quality standard, safety standard

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   EUROPEAN COMMISSION  Brussels, 9.3.2017  COM(2017) 127 final 2012/0267 (COD)   COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT  pursuant to Article 294(6) of the Treaty on the Functioning of the European Union  concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices  
 
2012/0267 (COD) 

COMMUNICATION FROM THE COMMISSION 
TO THE EUROPEAN PARLIAMENT 

pursuant to Article 294(6) of the Treaty on the Functioning of the European Union 

concerning the 

position of the Council on the adoption of a Regulation of the European Parliament and 
of the Council on in vitro diagnostic medical devices 

1. 

BACKGROUND 

Date of transmission of the proposal to the European Parliament and 
to the Council 
(document COM(2012) 541 final – 2012/0267 COD):  

Date  of  the  opinion  of  the  European  Economic  and  Social 
Committee: 

Date of the opinion of the Committee of the Regions:  

26.09.2012 

14.02.2013  

08.02.2013 

Date of the position of the European Parliament, first reading: 

02.04.2014 

Date of adoption of the position of the Council: 

07.03.2017 

2. 

OBJECTIVE OF THE PROPOSAL FROM THE COMMISSION 

In-vitro diagnostic medical devices (IVDs) (e.g. HIV blood tests, pregnancy tests, blood sugar 
monitoring  systems  for  diabetics)  are  currently  regulated  by  Directive  98/79/EC1.  This 
Directive, adopted in 1998, is based on the ‘New Approach’ and aims to ensure the smooth 
functioning of the internal market and a high level of protection of public health and patient 
safety. IVDs are not subject to a pre-market authorisation by a regulatory authority but to a 
conformity assessment procedure which, for medium and high-risk devices listed in Annex II 
of Directive 98/79/EC and a few other devices, 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  has  proved its  merits,  but  certain  significant  weaknesses 
and  divergences  in  the  interpretation  and  application  of  the  rules  have  been  revealed 
suggesting its urgent revision. In addition, the highly innovative and competitive nature of this 
sector  requires  the  EU  to  dispose  of  appropriate  and  up-to-date  regulatory  instruments  and 

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OJ L 331, 7.12.1998, p. 1 

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provide  all  relevant  economic  operators  with  the  necessary  legal  certainty.  Moreover,  there 
was  a  need  to  align  the  European  rules  on  IVDs  with  certain  consolidated  international 
principles. 

It  is  in  that  context  that  the  Commission  adopted  on  26  September  2012  a  proposal  for  a 
Regulation on in vitro diagnostic medical devices. 

The main objectives of the proposal were the following: 

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Wider and clearer scope for EU legislation, which is clarified particularly as regards 
genetic testing and companion diagnostics;  

Updated risk classification rules, as well as safety and performance requirements, to 
keep  pace  with  technological  and  scientific  progress  and  align  with  international 
principles; 

Stricter rules for designation and stronger supervision of notified bodies by national 
competent authorities; 

More  powers  for  notified  bodies,  to  ensure  thorough  testing  and  regular  checks  on 
manufacturers, including unannounced factory inspections; 

Scrutiny  mechanism  for  high-risk  devices  allowing  a  case-by-case  assessment  on 
scientifically valid grounds of the notified body’s preliminary conformity assessment 
by a committee of national experts; 

Clearer  obligations  for  manufacturers,  authorised  representatives,  importers  and 
distributors, which also apply in case of diagnostic services and internet sales; 

Stricter requirements for clinical evidence to support assessments of IVDs; 

Reinforced rules on vigilance and market surveillance; 

Improved  EU  medical  devices  database  (EUDAMED)  to  provide  comprehensive 
information on IVDs available on the EU market; 

Better  traceability  of  devices  throughout  the  supply  chain  to  enable  a  swift  and 
effective response in case of safety problems (e.g. recalls); and 

Enhanced coordination between national authorities, with the Commission providing 
scientific, technical and logistic support. 

3. 

COMMENTS ON THE POSITION OF THE COUNCIL 

The  Council’s  position  overall  endorses  the  objectives  pursued  by  the  Commission’s 
proposal, namely to ensure an increased level of patient safety and public health protection, 
facilitate  the  smooth  functioning  of  the  internal  market  and  support  innovation  in  this 
important sector. However, the Council makes certain changes as regards the manner in which 
these aims are achieved. The major changes proposed by the Council and the Commission's 
position on these changes can be summarised as follows. 

a) Information and counselling for genetic testing 
The Council’s position, building on certain elements of the EP 1st reading position, includes 
some minimum provisions requiring Member States to ensure that where a genetic test is used 
on individuals  in  the context  of healthcare, the subject to  the testing must  be provided with 
relevant information on the nature, significance and implications of the test, as appropriate. In 
particular,  there  should  be  appropriate  access  to  counselling  where  genetic  testing  provides 

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information  on diseases that  are considered to  be untreatable. The Commission  will  make  a 
statement about its future report concerning these provisions (see point 5 below).  

->  These  provisions  aim  to  ensure  a  reinforced  level  of  public  health  protection and  patient 
safety as well as enhanced information provision and can therefore be supported. 

b)  Exemption  of  devices  manufactured  and  used  in  the  same  health  institution  from  some 
requirements of the legislation 

Under  the  Council’s  position,  devices  manufactured  and  used  in  the  same  health  institution 
are  exempted  from  the  Regulation,  with  the  exception  of  the  relevant  general  safety  and 
performance requirements, if a number of conditions are fulfilled. These conditions include a 
prohibition to transfer the device to another legal entity, the requirement for manufacture and 
use  of  the  device  under  an  appropriate  quality  management  system,  the  obligation  for  the 
health institution to draw up and maintain a documentation for the device, as well as justify in 
this  documentation  that  the  patient's  needs  cannot  be  met  adequately  by  a  marketed  device. 
The exemption does not apply to devices manufactured on an industrial scale. 

-> Although this exemption is extended to all classes of IVDs, the position of the Council can 
be supported as it offers acceptable guarantees for control of these ‘in-house’ devices.  

c)  Financial  coverage  by  manufacturers  in  case  of  damage  caused  by  defective  medical 
devices 

The  Council’s  position  accepts  the  spirit  of  the  EP  1st  reading  position  introducing  a 
compulsory  liability  insurance  for  manufacturers,  as  it  recalls  the  right  of  natural  or  legal 
persons  to  claim  compensation  for  damage  caused  by  defective  devices  in  accordance  with 
applicable  Union  and  national  law.  To  this  end,  however,  the  Council's  position  does  not 
retain  the  compulsory  liability  insurance  envisaged  by  the  EP,  while  opting  instead  for  the 
manufacturers' obligation to have measures in place to provide sufficient financial coverage in 
respect  of  their  potential  liability  under  Directive  85/374/EEC  concerning  liability  for 
defective  products.  Such  financial  coverage  shall  be  proportionate  to  the  risk  class,  type  of 
device  and  the  size  of  the  enterprise.  This  obligation  introduced  by  the  Council  is  without 
prejudice to more protective measures under national law. 

-> This new feature of the legislation can be supported as it offers an important guarantee for 
patients and users of IVDs, while providing sufficient flexibility for manufacturers as regards 
the specific means to ensure such financial coverage.   

d) Liability of authorised representatives  

The  Council’s  position  reinforces  the  role  and responsibilities  for  authorised  representatives 
well  beyond  the  terms  of  the  Commission’s  proposal.  In  particular,  the  authorised 
representative  would  be  jointly  and  severally  liable  with  the  importer  and  manufacturer  in 
case of damages suffered due to defective devices.  

->  The  Commission's  proposal  had  provided  limited  legal  responsibilities  of  the  authorised 
representatives, taking into account that the authorised representatives have a limited role with 
regard to the placing on the market of a medical device and are generally not in a position to 
possess all relevant knowledge on the device design and the manufacturing process. However, 
in  the  course  of  the  legislative  negotiation  it  became  clear  that  there  are  many  specific 
enforcement problems linked to devices produced by non-EU manufacturers that the current 
horizontal liability regime  does  not  properly  address.  These enforcement  problems  could be 
highly  detrimental  to  the  protection  of  damaged  patients.  Therefore,  the  Council's    position 
can be supported in the interest of public health protection and patient safety.  

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e)  Identification  and  traceability  related  obligations  and  establishment  of  a  Unique  Device 
Identification (UDI) System  

As  in  the  Commission’s  proposal,  economic  operators  would  be  required  to  identify  any 
economic  operator  from  whom  they  have  received  a  device  and  to  whom  they  supplied  a 
device  (including  health  institutions  and  healthcare  professionals).  However,  contrary  to  the 
Commission’s  proposal  which  only  sets  out  the  legal  basis  and  the  main  principles  of  the 
future UDI system, leaving the details to the implementation stage, the Council’s position sets 
out detailed rules for the implementation of the UDI system. The main features of the position 
are the requirement for manufacturers to have the UDI code assigned to their devices by the 
date of application and the requirement for the UDI carrier to be placed on the device and all 
higher  levels  of  packaging  gradually  depending  on  the  risk  class  of  the  device.  Specific 
storage obligations can be defined by implementing acts for economic operators and imposed 
by Member States for health institutions. 

->  While  this  diverges  from  the  Commission’s  position,  it  is  overall  acceptable  in  terms  of 
device identification and traceability potential that the new system is going to ensure.  

f) European Databank on Medical Devices (‘EUDAMED’) 

The  Council’s  position  contains  more  extensive  requirements  for  information  upload  in 
EUDAMED and greater transparency of the information it contains, in particular, as regards 
clinical  data  for  devices  on  the  market.  In  addition,  it  foresees  that  the  operation  of 
EUDAMED and the application of provisions related to it should be subject to an independent 
audit of the functionality of the database.  

-> While it should be acknowledged that the Council’s position creates significant obligations 
for  the  Commission  in  establishing  a  very  extensive  database  and  in  setting  a  burdensome 
procedure  for  the  verification  of  the  database  functionality,  this  is  acceptable  as  it  would 
ensure greater transparency of information regarding devices on the market.  

g) Strengthened criteria for designation of notified bodies 

According  to  the  Council’s  position,  the  criteria  for  designation  of  notified  bodies  are 
described  in  greater  detail,  especially  as  regards  process  requirements.  In  addition,  the 
procedures  for  their  oversight  have  been  detailed  based  on  experience  of  joint  assessments 
already under the current legislation.  

->  The  Commission  supports  the  enhancement  of  the  requirements  for  the  designation  and 
oversight of notified bodies. 

h) Clinical evaluation consultation for certain high-risk devices  

The  Council’s  position,  building  on  elements  of  the  Commission  proposal’s  scrutiny 
procedure,  sets  out  the  verification  by  a  designated  reference  laboratory  of  the  performance 
claimed by manufacturers of class D IVDs and a consultation with an expert panel applicable 
to Class D IVDs devices, in the case of their first certification and when common technical 
specifications are not available. According to this procedure, an expert panel would provide a 
scientific  opinion  to  the  notified  body  on  its  assessment  of  the  manufacturer’s  clinical  file. 
While  the  notified  body  would  not  be  bound  by  the  opinion,  it  would  have  to  provide  a 
justification for not following it. All relevant documents regarding the opinion and the final 
decision  of  the  notified  body  would  be  publicly  available  in  EUDAMED.  The  concerned 
manufacturers may be subject to pay fees, the structure and level of which would be set out in 
implementing acts.  

->  The  Commission  can  support  the  position  which  is  very  much  in  line  with  the 
Commission’s objectives.  

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i) Reinforced requirements for clinical performance studies and clinical evidence 

Building  on  the  Commission’s  proposal,  the  procedures  for  authorisation  of  some 
performance  studies  have  been  further  aligned  with  the  rules  on  clinical  trials  on  medicinal 
products, particularly as regards provisions on informed consent and protection of vulnerable 
subjects.  A  longer  transitional  period  has  been  foreseen  for  the  coordinated  procedure  for 
assessment of applications for clinical investigations in more than one Member State so as to 
allow Member States to gain the necessary experience on a voluntary basis. 

->  The  Commission  can  support  the  reinforced  requirements  and  considers  appropriate  and 
well justified a longer transitional period for the coordinated assessment procedure. 

j) Post-market surveillance by manufacturers and extended scope of trend reporting 

The Council’s  position details the obligations of  manufacturers to  follow-up on the real-life 
use  of  their  devices  after  their  placing  on  the  market.  This  includes  the  requirements  for  a 
post-market surveillance system of the manufacturer and a post-market surveillance plan. The 
conclusions drawn on the basis of the analysis of all relevant post-market data are to be set out 
in a post-market surveillance report for low-risk devices and in a periodic safety update report 
for devices of a higher risk class. In addition, trend reporting obligations are no longer limited 
to the highest risk devices as was the case in the original Commission’s proposal. 

->  All  of  these  elements  can  be  supported  as  they  constitute  a  clear  improvement  of  the 
Commission’s proposal.  

k) Transitional periods 

While  the  Council’s  position  maintains  the  general  transitional  periods  of  5  years,  some 
specific  provisions  have  been  added.  In  particular,  Member  States  have  to  designate  the 
national  competent  authority  in  charge  of  medical  devices  within  12  months  after  the  entry 
into application; reference laboratories need to be designated by 18 months before the date of 
application. Certificates issued under the old legislation become void at the latest 2 years after 
the date of application. Devices lawfully placed on the market under the old directives prior to 
the date of application may continue to be made available on the market or put into service 
until 3 years after that date. 

-> The Commission supports the above outcomes. 

4. 

CONCLUSION 

The Council acted unanimously. 

In conclusion, the Commission supports the position adopted by the Council.  

5. STATEMENTS 

The Commission will make the following two statements: 

(1) 

Commission statement regarding the provisions for information and counselling 
in the field of genetic testing in Article 4 of the Regulation on in vitro diagnostic 
medical devices 

No later than five years after the date of application of the Regulation and in the framework of 
the  review  of  the  functioning  of  Article  4  foreseen  in  Article  111  of  the  Regulation,  the 
Commission  will  report  on  the  Member  States'  experience  with  the  implementation  of  the 
obligations in Article 4 for information and counselling in the context of use of genetic tests. 

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In  particular,  the  Commission  will  report  on  the  different  practices  in  place  in  light  of  the 
double  objective  pursued  by  the  Regulation,  namely  to  ensure  a  high  level  of  patient  safety 
and guarantee the smooth functioning of the internal market. 

(2) 

Commission statement regarding genetic testing used for lifestyle and wellbeing 
purposes 

With  respect  to  genetic  tests  intended  for  wellbeing  or  lifestyle  purposes,  the  Commission 
stresses  that  devices  without  any  medical  purpose,  including  those  which  are  intended  to 
directly or indirectly maintain or improve healthy behaviours, quality of life and wellbeing of 
individuals, are not covered by Article 2 (Definitions) of the Regulation on in vitro diagnostic 
medical devices. Nonetheless, the Commission intends to monitor, on the basis of the market 
surveillance  activities  carried  out  by  Member  States,  specific  safety  issues  which  might  be 
linked to the use of these devices.   

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