REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
Date: 2022-04-26
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: European Commission, delegated legislation, health legislation, marketing standard, medical device, medical diagnosis, patient's rights, quality standard, safety standard, transfer of competence

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 26.4.2022  COM(2022) 182 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

on the exercise of the power to adopt delegated acts conferred on the Commission 
pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 
on in vitro diagnostic medical devices 

1.  INTRODUCTION 

Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  on  medical 
devices1 and Regulation (EU) 2017/746 of the European Parliament and of the Council on in 
vitro diagnostic medical devices2 were adopted on 5 April 2017 and entered into force on 25 
May  2017.  Regulation  (EU)  2017/745  applies  since  26  May  20213.  Regulation  (EU) 
2017/746 will apply from 26 May 20224. 

Medical  devices  and  in  vitro  diagnostic  medical  devices  have  a  fundamental  role  in  saving 
lives by providing healthcare solutions for the diagnosis, prevention, monitoring, prediction, 
prognosis, treatment or alleviation of disease. Regulations (EU) 2017/745 and (EU) 2017/746 
aim to provide a robust, transparent and sustainable regulatory framework in order to ensure a 
high  level  of  safety  and  performance  of  medical  devices  and  in  vitro  diagnostic  medical 
devices, while supporting innovation.  

Regulations  (EU)  2017/745  and  (EU)  2017/746  empower  the  Commission  to  adopt  several 
delegated  acts.  The  Commission  is  required  to  report  to  the  European  Parliament  and  the 
Council on the delegations of power not later than nine months before the end of the five-year 
period. 

2.  LEGAL BASIS 

With  this  report,  the  Commission  meets  the  reporting  requirements  established  in  Article 
115(2)  of  Regulation  (EU)  2017/745  and  Article  108(2)  of  Regulation  (EU)  2017/746. 
Pursuant to those provisions, the power to adopt delegated acts referred to in the provisions 
listed  therein  (i.e.  Articles  1(5),  3,  10(4),18(3),  19(4),  27(10),  44(11),  52(5),  56(6),  61(8), 
70(8) and 106(15) of Regulation (EU) 2017/745 and Articles 10(4), 17(4), 24(10), 51(6) and 

1   Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  of  5 April  2017  on  medical 
devices, 
and 
Regulation (EC) No 1223/2009  and  repealing  Council  Directives  90/385/EEC  and  93/42/EEC,  OJ  L  117, 
5.5.2017, p. 1. 

Regulation (EC) No 178/2002 

Directive 2001/83/EC, 

amending 

3  

2   Regulation  (EU)  2017/746  of  the  European  Parliament  and  of  the  Council  of  5 April  2017  on  in  vitro 
diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU,  OJ 
L 117, 5.5.2017, p. 176. 
Its date of application had been postponed by one year due to the COVID-19 pandemic by Regulation (EU) 
2020/561  of  the  European  Parliament  and  of  the  Council  of  23  April  2020  amending  Regulation  (EU) 
2017/745  on  medical  devices,  as  regards  the  dates  of  application  of  certain  of  its  provisions,  OJ  L  130, 
24.4.2020, p. 18. 

4   Regulation  (EU)  2022/112  of  the  European  Parliament  and  of  the  Council  of  25  January  2022  amending 
Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices 
and  the  deferred  application  of  conditions  for  in-house  devices,  OJ  L  19,  28.1.2022,  p.  3,  has  introduced 
additional transitional provisions in the Regulation (EU) 2017/746. 

1 

 
 
                                                           
66(8)  of  Regulation  (EU)  2017/7465),  is  conferred  on  the  Commission  for  a  period  of  five 
years from 25 May 2017.  

Article 115(2) of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746 
lay  down  that  the  delegations  of  power  are  to  be  tacitly  extended  for  periods  of  identical 
duration, unless the European Parliament or the Council opposes such extension not later than 
three months before the end of each period. 

3.  EXERCISE OF THE DELEGATIONS 

The  Commission  has  not  yet  exercised  the  delegated  powers  conferred  to  it  under  the 
respective  provisions  of  Regulations  (EU)  2017/745  and  (EU)  2017/746.  This  is  primarily 
due  to  the  fact  that  Regulation  (EU)  2017/745  has  been  applicable  since  26  May  2021  and 
Regulation  (EU)  2017/746  will  apply  from  26  May  2022.  Hence,  there  is  at  present  only 
limited experience on their application in practice. Further explanations are provided below 
for each of the empowerments.  

  Products without an intended medical purpose 

Article  1(5)  of  Regulation  (EU)  2017/745  empowers  the  Commission  to  adopt 
delegated  acts  to  amend  Annex  XVI  to  that  Regulation.  Annex  XVI  lists  groups  of 
products  without  an  intended  medical  purpose  as  referred  to  in  Article  1(2).  The 
Commission  is  empowered  to  add  new  groups  of  products  in  order  to  protect  the 
health and safety of users, other persons or other aspects of public health. The groups 
of products listed in Annex XVI are still up to date. 

  Amendment of the definition of ‘nanomaterial’ and related definitions 

Article 3 of Regulation (EU) 2017/745 empowers the Commission to adopt delegated 
acts to amend the definition of ‘nanomaterial’ set out in Article 2(18) and the related 
definitions of ‘particle’, ‘agglomerate’ and ‘aggregate’ set out in Article 2(19), (20), 
(21)  in  light  of  technical  and  scientific  progress  and  taking  into  account  definitions 
agreed  at  Union  and  international  level.  The  before-mentioned  definitions  are  based 
on Commission  Recommendation 2011/696/EU6 which has not  yet  been updated. A 
review of that Recommendation is ongoing and is expected to result in the adoption of 
a  revised  Recommendation  and  accompanying  staff  working  document  in  the  first 
half  of  2022.  Should  the  definition  of  ‘nanomaterial’  be  amended  in  that 
Recommendation, the Commission  will assess  the need to  amend  the  corresponding 
and related definitions in Regulation (EU) 2017/745, in order to maintain consistency 
with that Recommendation. 

  Elements to be included in the technical documentation and technical documentation 

on post-market surveillance 

5  

In  addition,  Article  40(11)  of  Regulation  (EU)  2017/746,  which  is  not  mentioned  in  Article  108  of  that 
Regulation, contains an empowerment to adopt delegated acts. 

6    Commission Recommendation of 18 October 2011 on the definition of nanomaterial, OJ L 275, 20.10.2011, 

p. 38. 

2 

 
 
                                                           
Article  10(4)  of  Regulations  (EU)  2017/745  and  (EU)  2017/746  empowers  the 
Commission to adopt delegated acts to amend, in the light of technical progress, the 
elements to be included in the technical documentation and technical documentation 
on  post-market  surveillance  pursuant  to  Annexes  II  and  III  to  Regulations  (EU) 
2017/745  and  (EU)  2017/746.  Technical  progress  has  not  yet  given  rise  to  the  need 
for any amendments. 

  Exemption from the requirement of an implant card  

Article 18(3) of Regulation (EU) 2017/745 includes a list of implants exempted from 
the  requirements  of  an  implant  card  and  empowers  the  Commission  to  adopt 
delegated  acts  to  amend  that  list  by  adding  other  types  of  implants  to  it  or  by 
removing implants therefrom. To date, no need for updating the list has arisen in view 
of well-established technologies or in order to protect the health and safety of patients, 
users or other persons or other aspects of public health. 

  Minimum content of the EU declaration of conformity  

Article  19(4)  of  Regulation  (EU)  2017/745  and  Article  17(4)  of  Regulation  (EU) 
2017/746 empower the Commission to adopt delegated acts to amend, in the light of 
technical progress, the minimum content of the EU declaration of conformity set out 
in  Annex  IV  to  Regulations  (EU)  2017/745  and  (EU)  2017/746.  Technical  progress 
has not yet given rise to the need for an amendment. 

 

Information to be submitted as part of the Unique Device Identification (UDI) system  

Article  27(10)  of  Regulation  (EU)  2017/745  and  Article  24(10)  of  Regulation  (EU) 
2017/746 empower the Commission to adopt delegated acts to amend Annex VI to the 
respective Regulation in the light of technical progress or international developments 
in the field of Unique Device Identification. The Commission is currently preparing a 
delegated  act  pursuant  to  Article  27(10),  point  (b),  of  Regulation  (EU)  2017/745, 
amending  Annex  VI  to  Regulation  (EU)  2017/745  as  regards  UDI  assignment  for 
contact lenses.  

  Frequency of complete re-assessment of notified bodies 

Article  44(11)  of  Regulation  (EU)  2017/745  and  Article  40(11)  of  Regulation  (EU) 
2017/746 empower the Commission to adopt delegated acts to modify the frequency 
at which the complete re-assessment of notified bodies with regard to the fulfilment of 
the  requirements  in  Annex  VII  to  the  respective  Regulation  is  to  be  carried  out. 
Currently,  Article  44(10)  of  Regulation  (EU)  2017/745  and  Article  40(10)  of 
Regulation  (EU)  2017/746  provide  for  such  re-assessment  three  years  after 
notification  and  again  every  fourth  year  thereafter.  The  first  notified  body  under 
Regulation (EU) 2017/745 was designated in January 20197, so there is little practical 

7   Currently,  27  notified  bodies  are  designated  under  Regulation  (EU)  2017/745  (EUROPA  -  European 
Commission  -  Growth  -  Regulatory  policy  -  NANDO)  and  6  notified  bodies  are  designated  under 
Regulation (EU) 2017/746 (EUROPA - European Commission - Growth - Regulatory policy - NANDO). 

3 

 
 
                                                           
experience  which  would  have  justified  the  adaptation  of  the  frequency  of  re-
assessment laid down in the Regulations. 

  Exemption  of  certain  well-established  technologies  from  assessment  of  technical 

documentation for every single device  

Article  52(5)  of  Regulation  (EU)  2017/745  empowers  the  Commission  to  adopt 
delegated acts to amend the list of devices in Article 52(4), second subparagraph, of 
Regulation (EU) 2017/745 by adding other types of class IIb implantable devices to 
that list or removing devices therefrom. The list contains class IIb implantable devices 
exempted from the assessment of the technical documentation as specified in Section 
4 of Annex IX to Regulation (EU) 2017/745 for every single device. The assessment 
of  at  least  one  representative  device  per  generic  device  group  suffices.  It  may  be 
justified in the future in view of well-established technologies to add further devices 
to that list or to remove devices from the list in order to protect the health and safety 
of patients, users or other persons or other aspects of public health. 

  Minimum content of certificates issued by a notified body 

Article  56(6)  of  Regulation  (EU)  2017/745  and  Article  51(6)  of  Regulation  (EU) 
2017/746 empower the Commission to adopt delegated acts to amend, in the light of 
technical progress, the minimum content of certificates issued by a notified body. The 
minimum  content  of  certificates  issued  by  a  notified  body  is  listed  in  Annexes  XII 
toRegulations  (EU)  2017/745  and  (EU)  2017/746.  Both  Regulations  include 
transitional  provisions  allowing  devices  to  be  placed  on  the  market  with  certificates 
issued  in  accordance  with  the  previous  Directives.  Therefore,  there  is  not  enough 
practical experience on the issuing of certificates under the Regulations which would 
have given rise to amend their minimum content.  

  Exemption  of  certain  well-established  technologies  from  assessment  of  technical 
documentation for every single device  and from  the requirement to  perform clinical 
investigations  

Article  61(8)  of  Regulation  (EU)  2017/745  empowers  the  Commission  to  adopt 
delegated  acts  to  amend both  the list  in  Article  52(4), second subparagraph, already 
mentioned above, and the list in Article 61(6) point (b) of Regulation (EU) 2017/745 
containing  implantable  devices  exempted  from  the  requirement  to  perform  clinical 
investigations  pursuant  to  Article  61(4)  of  Regulation  (EU)  2017/745.  It  may  be 
justified in the future in view of well-established technologies to add further devices 
to  those  lists  or  to  remove  devices  from  the  lists  in  order  to  protect  the  health  and 
safety of patients, users or other persons or other aspects of public health. 

  Documentation regarding the application for clinical investigation and  interventional 

clinical performance studies 

Article  70(8)  of  Regulation  (EU)  2017/745  and  Article  66(8)  of  Regulation  (EU) 
2017/746 empower the Commission to adopt delegated acts to amend, in the light of 
technical  progress  and  global  regulatory  developments,  Annex  XV,  Chapter  II,  to 

4 

 
 
Regulation (EU) 2017/745 and Annex XIV, Chapter I, to Regulation (EU) 2017/746, 
which  lay  down  the  requirements  for  documentation  regarding  the  application  for 
clinical  investigation  and  for  interventional  clinical  performance  studies  and  other 
performance  studies  involving  risks  for  the  subjects  of  the  studies,  respectively.  To 
date, no need for updating the documentation requirements has arisen.  

  Tasks of expert panels and expert laboratories 

Article  106(15)  of  Regulation  (EU)  2017/745  empowers  the  Commission  to  adopt 
delegated acts to amend the tasks of expert panels and expert laboratories, which are 
listed in Article 106(10) of Regulation (EU) 2017/745. Expert panels were designated 
by  Commission  Implementing  Decision  (EU)  2019/13968  and  started  their  work  in 
April  2021.  Expert  laboratories  have  not  yet  been  designated.  To  date,  no  need  for 
changing the tasks of expert panels or expert laboratories has arisen.  

4.  CONCLUSION 

The Commission sees the need for a tacit extension of the delegations of power provided for 
in  Article  115(2)  of  Regulation  (EU)  2017/745  and  Article  108(2)  of  Regulation  (EU) 
2017/746 for a period of five years, in accordance with those Articles.  

The need to develop and adopt rules based on the empowerments granted by Article 115(2) 
of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746 may arise in 
the  future.  The  rationale  for  the  delegations  of  power  has  not  changed.  It  is  important  to 
maintain  the  necessary  flexibility  in  the  legal  framework,  to  supplement  or  adjust  it  to 
technical  and  scientific  developments  with  a  view  to  protect  health  and  safety  of  patients, 
users and public health in general based also on more experience gained with the application 
of the Regulations. 

The Commission invites the European Parliament and the Council to take note of this report. 

8   Commission Implementing Decision (EU) 2019/1396  of 10 September 2019 laying down the rules for the 
application  of  Regulation  (EU)  2017/745  of  the  European  Parliament  and  of  the  Council  as  regards  the 
designation of expert panels in the field of medical devices, OJ L 234, 11.9.2019, p. 23. 

5