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 medical devices
Date: 2017-03-09
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: marketing standard, medical device, quality standard, safety standard, technical specification

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   EUROPEAN COMMISSION  Brussels, 9.3.2017  COM(2017) 129 final 2012/0266 (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 medical devices  
 
2012/0266 (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 medical devices 

1. 

BACKGROUND 

Date of transmission of the proposal to the European Parliament and 
to the Council 

(document COM(2012) 542 final – 2012/0266 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 

The medical devices sector is estimated to comprise more than 500 000 products, covering a 
huge  spectrum  of  products,  from  sticking  plasters  to  contact  lenses,  X-ray  machines, 
pacemakers or blood tests. 

Medical devices other than in-vitro diagnostic medical devices are currently regulated by two 
main  Directives:  Directive  90/385/EEC1  regarding  active  implantable  medical  devices  (e.g. 
pacemakers) and Directive 93/42/EEC2 regarding medical devices (e.g. contact lenses). These 
two Directives, adopted in the 1990s, are based on the ‘New Approach’ and aim to ensure the 
smooth functioning of the internal market and a high level of protection of public health and 
patient safety. Medical devices 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, 
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. 

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OJ L 189, 20.7.1990, p. 17 
OJ L 169, 12.7.1993, p. 1 

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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 
provide all relevant economic operators with the necessary legal certainty. 

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

The main objectives of the proposal were the following: 

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Wider  and  clearer  scope  for  EU  legislation,  which  is  extended  to  include  some 
products (e.g. implants for aesthetic purposes)  

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

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; 

Harmonised rules on reprocessing of single-use medical devices; 

Stricter requirements for clinical evidence to support assessments of devices; 

Reinforced rules on vigilance and market surveillance; 

Improved  EU  medical  devices  database  (EUDAMED)  to  provide  comprehensive 
information on devices 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 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) Inclusion of certain products without a medical purpose in the scope of the medical devices 
Regulation 

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Under  the  Council’s  position,  the  application  of  the  Regulation  to  certain  listed  groups  of 
products without a medical purpose (e.g. contact lenses; equipment for liposuction, lipolysis 
or  lipoplasty;  equipment  intended  for  brain  stimulation)  is  dependent  on  the  adoption  of 
common technical specifications (‘CS’) covering the risk management and, where necessary, 
the  clinical  evaluation  regarding  safety  aspects.  The  CS  would  apply  as  of  six  months  after 
their entry into force or date of application of the Regulation, whichever is the latest.  

-> Although the inclusion of the listed groups of products in the scope of the medical devices 
legislation is not automatic, as the Commission proposed, but is dependent on the adoption of 
the  CS,  the  position  of  the  Council  can  be  supported  as  the  specifications  may  be  useful  to 
elaborate some specific aspects concerning the application of the medical device legislation to 
these products. 

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 introduced for the first time for medical devices, 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 medical devices, 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 

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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.  

e) Reprocessing of single-use medical devices 

Under  the  Council’s  position,  the  reprocessing of  single-use  medical  devices  may  only  take 
place  when  authorised  under  national  law  and  in  accordance  with  the  provisions  of  the 
medical devices Regulation. When reprocessing is allowed, the reprocessor must assume the 
obligations  of  a  manufacturer.  However,  a  different  regime  is  applied  in  the  case  of 
reprocessing  by  health  institutions  and  by  third  parties  on  the  request  of  health  institutions. 
Under  this  regime  Member  States  may  decide  not  to  apply  certain  rules  relating  to 
manufacturers’  obligations  if  certain  conditions  are  fulfilled,  namely  compliance  with 
common specifications. The Commission is required to adopt these common specifications by 
the  date  of  application  of  the  legislation  and  if  it  fails  to  do  so,  harmonised  standards  and 
national  provisions  would  apply.  Compliance  with  the  relevant  common  specifications  or 
national provisions and harmonised standards would have to be certified by a notified body. 
Member States should encourage and may require health institutions to provide information to 
patients  on  the  use  of  the  reprocessed  device  within  the  health  institution;  they  may  adopt 
stricter provisions or ban reprocessing on their territory (so-called ‘opt-out’). 

->  This  approach  is  significantly  different  from  the  Commission’s  proposal  which  foresaw 
that  all  reprocessors  would  be  considered  as  manufacturers  and  that  single-use  devices  for 
critical use could not be reprocessed. Nevertheless, given the diversity of national approaches 
and  the  sensitivity  of  the  issue  from  a  public  health  and  patient  safety  point  of  view,  the 
Council’s position appears to be an acceptable way forward to establish EU-wide minimum 
rules  applicable  to  the  reprocessing  of  single-use  medical  devices  and  can  therefore  be 
supported.  

f) Use of hazardous substances in invasive medical devices 
The  Council’s  position  accepts  the  spirit  of  the  EP  1st  reading  position,  as  it  sets  a  stricter 
regime  for  the  use  of  certain  hazardous  substances  in  medical  devices.  According  to  the 
Council’s position, manufacturers must provide a justification to the notified body regarding 
the presence of CMR substances and/ or endocrine disruptors above a certain concentration in 
invasive  medical  devices  and  devices  that  transport  and  store  medicinal  products,  or  other 
substances  to  be  (re)administered  into  or  removed  from  the  body.  For  this  purpose,  the 
Commission is required, as soon as possible and at the latest one year after the date of entry 
into force of this regulation, to provide the relevant Scientific Committee with a mandate to 
prepare  guidelines  on  the  presence  of  phthalates.  The  Commission  shall  also  mandate  the 
relevant  Scientific  Committee  to  prepare  guidelines  in  relation  to  other  CMR  or  endocrine 
disrupting  substances,  where  necessary.  Moreover,  the  list  of  such  substances  contained  in 
such devices must appear on the label of the device and/or on the packaging for each unit or, 
where appropriate, on the sales packaging.  

->  This  approach  can  be  supported,  as  it  aims  at  an  increased  level  of  patient  and  user 
protection. 

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

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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. Storage of the 
UDI code by health institutions and economic operators is mandatory for class III implantable 
devices.  Further  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.  

h) 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 rather onerous 
procedure  for  the  verification  of  the  database  functionality,  this  is  acceptable  as  it  would 
ensure greater transparency of information regarding devices on the market.  

i) 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. 

j) Clinical evaluation consultation for certain high-risk devices  

The  Council’s  position,  building  on  the  rationale  of  the  Commission  proposal’s  scrutiny 
procedure and taking into account certain elements of the scope of this procedure as defined 
in the EP 1st reading position, sets out a consultation with an expert panel applicable to certain 
high-risk  devices.  According  to  this  procedure,  an  expert  panel  could  select  a  file  based  on 
specified criteria and 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.  

k) Reinforced requirements for clinical investigations and clinical data 

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Building  on  the  Commission’s  proposal  and  the  EP  1st  reading  position,  the  procedures  for 
authorisation  of  clinical  investigations  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.  The  obligations  for  manufacturers  to  carry  out  clinical 
investigations  for  high-risk  devices  have  been  strengthened  with  exemptions  for  well-
established  technologies.  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. 

->  These  reinforced  requirements  are  supported  by  the  Commission  and  the  Commission 
considers appropriate and well justified both the exemptions for well-established technologies 
and a longer transitional period for the coordinated assessment procedure. 

l) 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. For class III and implantable devices, manufacturers would 
be  required  to  submit  the  report  to  their  notified  body  via  EUDAMED.  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.  

m) Transitional periods 

While  the  Council’s  position  maintains  the  general  transitional  periods  of  3  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. Certificates issued under the old legislation become void at the latest 4 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 5 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.  

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