Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions
Date: 2020-04-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EC conformity marking, epidemic, harmonisation of standards, health legislation, infectious disease, market approval, marketing standard, medical device, quality standard, safety standard

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   EUROPEAN COMMISSION  Brussels, 3.4.2020  COM(2020) 144 final 2020/0060 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions (Text with EEA relevance)  
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 

Regulation (EU) 2017/745 of the European Parliament and of the Council, adopted 
on  5  April  2017,  establishes  a  new  regulatory  framework  to  ensure  the  smooth 
functioning  of  the  internal  market  as  regards  medical  devices  covered  by  that 
Regulation,  taking  as  a  base  a  high  level  of  protection  of  health  for  patients  and 
users, and taking into account the small- and medium-sized enterprises that are active 
in this sector.  

The  COVID-19  outbreak  and  the  associated  public  health  crisis  presents  an 
unprecedented  challenge  to  the  Member  States  and  is  a  high  burden  for  national 
authorities, health institutions, EU citizens and economic operators. The COVID-19 
crisis  has  created  extraordinary  circumstances  that  demand  substantial  additional 
resources,  as  well  as  an  increased  availability  of  vitally  important  medical  devices, 
that could not reasonably have been anticipated at the time of adoption of Regulation 
(EU) 2017/745.  

Those  extraordinary  circumstances  have  a  significant  impact  on  various  areas 
covered  by  Regulation  (EU)  2017/745  and  therefore  it  is  very  likely  that  Member 
States, health institutions, economic operators and other relevant parties will not be 
in a position to ensure the proper implementation and application of that Regulation 
from 26 May 2020 as it provides for. 

In  order  to  ensure  the  smooth  functioning  of  the  internal  market,  a  high  level  of 
protection of public health and patient safety, to provide legal certainty, and to avoid 
potential  market  disruption,  it  is  necessary  to  defer  the  application  of  certain 
provisions  of  Regulation  (EU)  2017/745  by  one  year.  At  the  same  time,  it  is 
necessary  to  defer  the  date  of  repeal  of  Directives  90/385/EEC  and  93/42/EEC. 
Those  deferrals  safeguard  the  presence  of  a  functioning  regulatory  framework  on 
medical devices from 26 May  2020.  In  addition, the proposed amendment  seeks to 
ensure  that  the  Commission  is  able  to  adopt,  in  exceptional  cases,  Union-wide 
derogations in response to national derogations at the earliest date possible in order 
to address potential shortages Union wide of vitally important medical devices in an 
effective manner.  

2. 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

The proposal is based on Articles 114 and 168(4)(c) of the Treaty on the Functioning 
of the European Union (TFEU).  

Subsidiarity 

According  to  the  principle  of  subsidiarity,  Union  action  may  only  be  taken  if  the 
envisaged  aims  cannot  be  achieved  by  Member  States  alone.  Union  intervention  is 
required  to  ensure  a  high  level  of  protection  of  health  for  patients  and  users,  the 
smooth functioning of the internal market and avoid potential market disruption. In 
this regard, the legislation, that is being amended, is adopted in full compliance with 
the  principle  of  subsidiarity  and  any  amendment  thereto  must  be  made  through  a 
Commission proposal. 

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Proportionality 

This Union action is necessary to achieve the objective of the proper implementation 
and  application  of  Regulation  (EU)  2017/745  by  all  involved  parties,  taking  into 
account the magnitude of the current COVID-19 outbreak and the associated public 
health crisis. The proposed amendment aims to ensure that the intended purpose of 
Regulation (EU) 2017/745, that is, to establish a robust, transparent, predictable and 
sustainable regulatory framework for medical devices, which guarantees a high level 
of  protection  of  public  health  and  patient  safety  and  the  smooth  functioning  of  the 
internal market for such devices, can be attained. 

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

This  proposal  is  not  accompanied  by  a  separate  impact  assessment,  as  an  impact 
assessment  for  Regulation  (EU)  2017/745  has  already  been  undertaken.  This 
proposal does not alter Regulation (EU) 2017/745 on substance and does not impose 
new  obligations  on  the  concerned  parties.  It  primarily  aims  at  providing,  for 
exceptional  reasons  in  the  context  of  the  current  COVID-19  outbreak,  a  one-year 
deferral as regards the date of application of certain provisions of that Regulation. 

4. 

BUDGETARY IMPLICATIONS 

The proposal does not have a budgetary impact for the EU institutions. 

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2020/0060 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EU) 2017/745 on medical devices as regards the dates of 
application of certain of its provisions 

(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, 

After consulting the European Economic and Social Committee, 

After consulting the Committee of the Regions, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

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Regulation (EU) 2017/745 of the European Parliament and of the Council1 establishes 
a new regulatory framework to ensure the smooth functioning of the internal market as 
regards medical devices covered by that  Regulation,  taking as  a base a high  level of 
protection  of  health  for  patients  and  users,  and  taking  into  account  the  small-  and 
medium-sized enterprises  that are active in  this sector.  At the  same time, Regulation 
(EU) 2017/745 sets high standards of quality and safety for medical devices in order to 
meet  common  safety  concerns  as  regards  such  devices.  Regulation  (EU)  2017/745 
significantly  reinforces  key  elements  of  the  existing  regulatory  approach  in  Council 
Directive 90/385/EEC2 and Council Directive 93/42/EEC3, such as the supervision of 
notified bodies, conformity assessment procedures, clinical investigations and clinical 
evaluation, vigilance and  market surveillance, whilst  introducing provisions ensuring 
transparency and traceability regarding medical devices, to improve health and safety.  

The  COVID-19  outbreak  and  the  associated  public  health  crisis  presents  an 
unprecedented  challenge  to  the  Member  States  and  is  a  high  burden  for  national 
authorities,  health  institutions,  EU  citizens,  and  economic  operators.  The  COVID-19 
crisis  has  created  extraordinary  circumstances  that  demand  substantial  additional 
resources, as well as an increased availability of vitally important medical devices, that 
could not reasonably have been anticipated at the time of adoption of Regulation (EU) 

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  amending  Directive  2001/83/EC,  Regulation  (EC)  No  178/2002  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). 
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17). 
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1). 

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2017/745.  Those  extraordinary  circumstances  have  a  significant  impact  on  various 
areas  covered  by  Regulation  (EU)  2017/745,  such  as  the  designation  and  work  of 
notified bodies and the placing on the market and making available on the market of 
medical devices in the Union.  

(3)  Medical devices, such as medical gloves, surgical masks, equipment for intensive care 
and  other  medical  equipment,  play  a  crucial  role  in  the  context  of  the  COVID-19 
outbreak  and  the  associated  public  health  crisis  to  ensure  the  health  and  safety  of 
Union  citizens  and  to  enable  Member  States  to  give  patients  urgently  in  need  the 
necessary medical treatment.  

(4) 

(5) 

(6) 

(7) 

Given the unprecedented magnitude of the current challenges, and taking into account 
the  complexity  of  Regulation  (EU)  2017/745,  it  is  very  likely  that  Member  States, 
health  institutions,  economic  operators  and  other  relevant  parties  will  not  be  in  a 
position to ensure the proper implementation and application of that Regulation from 
26 May 2020 as it provides for. 

In  order  to  ensure  the  smooth  functioning  of  the  internal  market,  a  high  level  of 
protection of public health and patient safety, to provide legal certainty, and to avoid 
potential  market  disruption,  it  is  necessary  to  defer  the  application  of  certain 
provisions of Regulation (EU) 2017/745. Taking into account the COVID-19 outbreak 
and the associated public health crisis, its epidemiological development, as well as the 
additional  resources  required  in  the  Member  States,  health  institutions,  economic 
operators  and  other  relevant  parties,  it  is  appropriate  to  defer  the  application  of  the 
relevant provisions of Regulation (EU) 2017/745 by one year.  

The  application  should  be  deferred  for  provisions  of  Regulation  (EU)  2017/745  that 
would  otherwise  start  to  apply  from  26  May  2020.  To  ensure  the  continuous 
availability  of  medical  devices  on  the  Union  market,  including  medical  devices  that 
are  vitally  important  in  the  context  of  the  COVID-19  outbreak  and  the  associated 
public  health  crisis,  it  is  also  necessary  to  adapt  certain  transitional  provisions  of 
Regulation (EU) 2017/745 that would otherwise no longer apply  as from the date of 
application of those provisions.  

Both  Directives  90/385/EEC  and  93/42/EEC,  as  well  as  Regulation  (EU)  2017/745, 
empower  national  competent  authorities,  on  a  duly  justified  request,  to  authorise  the 
placing  on  the  market  of  medical  devices  for  which  the  relevant  conformity 
assessment procedures have not been carried out, but the use of which is in the interest 
of  protection  of  health,  or  in  the  interest  of  public  health  or  patient  safety  or  health 
respectively  (‘national  derogation’).  Regulation  (EU)  2017/745  also  allows  the 
Commission to extend, in exceptional cases, the validity of a national derogation for a 
limited period of time to the territory of the Union (‘Union-wide derogation’). Taking 
into  account  the  COVID-19  outbreak  and  the  associated  public  health  crisis,  the 
Commission should be able to adopt Union-wide derogations in response to national 
derogations  in  order  to  address  potential  shortages  Union  wide  of  vitally  important 
medical  devices  in  an  effective  manner.  It  is  for  this  reason  appropriate  that  the 
relevant  provision  of  Regulation  (EU)  2017/745  applies  at  the  earliest  date  possible 
and  that  the  corresponding  provisions  of  Directives  90/385/EEC  and  93/42/EEC  are 
repealed from that same date. In order to take account of the fact that the possibility to 
adopt  Union-wide  derogations  must,  for  a  transitional  period,  be  given  to  the 
Commission  in  relation  to  national  derogations  from  Directives  90/385/EEC  and 
93/42/EEC,  certain  amendments  to  the  relevant  provisions  of  Regulation  (EU) 
2017/745 are necessary.  

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(8) 

(9) 

In order to cover any national derogations granted by the Member States in accordance 
with Directives 90/385/EEC or 93/42/EEC in the context of the COVID-19 outbreak 
before  the  entry  into  force  of  this  Regulation,  it  is  also  necessary  to  provide  for  the 
possibility  for  the  Member  States  to  notify  those  national  derogations  and  for  the 
Commission to extend their validity to the territory of the Union.  

To  ensure  the  continuous  presence  of  a  functioning  and  effective  regulatory 
framework  for  medical  devices  it  is  necessary  to  also  defer  the  application  of  the 
provision repealing Directives 90/385/EEC and 93/42/EEC. 

(10)  Regulation (EU) 2017/745 should therefore be amended accordingly. 

(11)  Since  the  objectives  of  this  Regulation,  namely  to  defer  the  application  of  certain 
provisions of Regulation (EU) 2017/745 and to allow for the extension of the validity 
of  national derogations, authorised under Directives 90/385/EEC or 93/42/EEC, to the 
territory of the Union, cannot be sufficiently achieved by the Member States but can 
rather, by reason of its scale and effects, 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 those objectives. 

(12)  The  adoption  of  this  Regulation  takes  place  under  exceptional  circumstances  arising 
from  the  COVID-19  outbreak  and  the  associated  public  health  crisis.  To  attain  the 
intended  effect  of  amending  Regulation  (EU)  2017/745  as  regards  the  dates  of 
application of certain provisions, it is necessary for this Regulation to enter into force 
before  26 May  2020. It was therefore  considered  to  be appropriate to provide for an 
exception to the eight-week period referred to in Article 4 of Protocol No 1 on the role 
of  national  Parliaments  in  the  European  Union,  annexed  to  the  Treaty  on  European 
Union,  to  the  Treaty  on  the  Functioning  of  the  European  Union  and  to  the  Treaty 
establishing the European Atomic Energy Community. 

(13) 

In  light  of  the  overriding  need  to  immediately  address  the  public  health  crisis 
associated with the COVID-19 outbreak, this Regulation should enter into force as a 
matter of urgency,  

HAVE ADOPTED THIS REGULATION: 

Regulation (EU) 2017/745 is amended as follows: 

(1) 

in Article 1(2), the second subparagraph is amended as follows: 

Article 1 

(a) 

in the first sentence, ’26 May 2020’ is replaced by ’26 May 2021’,  

(b) 

in the second sentence, ’26 May 2020’ is replaced by ’26 May 2021’;  

(2) 

Article 17 is amended as follows: 

(a) 

paragraph 5 is amended as follows: 

(i) 

in the first sentence, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

(ii) 

in the third sentence, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

(b) 

in paragraph 6, ‘26 May 2020’ is replaced by ‘26 May 2021’; 

(3) 

in Article 34(1), ‘25 March 2020’ is replaced by ’25 March 2021’; 

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(4) 

Article 59 is amended as follows: 

(a) 

paragraph 1 is replaced by the following: 

‘1. 

By  way  of  derogation  from  Article  52 of  this  Regulation  or,  for  the 
period from [insert date – date of entry into force of this Regulation] to 
25  May  2021,  by  way  of  derogation  from  Article  9(1)  and  (2)  of 
Directive  90/385/EEC  or  from  Article  11(1)  to  (6)  of  Directive 
93/42/EEC, any competent authority may authorise, on a 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  applicable  procedures  referred  to  in  those  Articles  have  not  been 
carried out but use of which is in the interest of public health or patient 
safety or health.’, 

(b) 

in paragraph 2, the following subparagraph is added: 

‘The Member State may inform the Commission and the other Member States 
of  any  authorisation  granted  in  accordance  with  Article  9(9)  of  Directive 
90/385/EEC  or  Article  11(13)  of  Directive  93/42/EEC  before  [insert  date  – 
date of entry into force of this Regulation].’, 

(c) 

in paragraph 3, the first subparagraph is replaced by the following: 

‘Following  a  notification  pursuant  to  paragraph  2  of  this  Article,  the 
Commission, in exceptional cases relating to public health or patient safety or 
health,  may,  by  means  of  implementing  acts,  extend  for  a  limited  period  of 
time the validity of an authorisation granted by a Member State in accordance 
with paragraph 1 of this Article or, when granted before [insert date – date of 
entry  into  force  of  this  Regulation],  in  accordance  with  Article  9(9)  of 
Directive 90/385/EEC or Article 11(13) of Directive 93/42/EEC 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 114(3).’; 

(5) 

(6) 

in Article 113, ’25 February 2020’ is replaced by ’25 February 2021’; 

Article 120 is amended as follows: 

(a) 

in paragraph 1, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

(b)  paragraph 4 is replaced by the following: 

‘4.  Devices 

lawfully  placed  on 

the  market  pursuant 

to  Directives 
90/385/EEC and 93/42/EEC prior to 26 May 2021, and devices placed on 
the  market  from  26  May  2021  pursuant  to  paragraph 3  of  this  Article, 
may continue to be made available on the market or put into service until 
26 May 2025.’, 

(c) 

in paragraph 5, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

(d)  paragraph 6 is amended as follows: 

(i) 

in the first sentence, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

(ii) 

in the second sentence, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

in paragraph 10, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

paragraph 11 is amended as follows: 

(e) 

(f) 

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(i) 

in the first sentence, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

(ii) 

in the second sentence, ‘26 May 2020’ is replaced by ‘26 May 2021’; 

(7) 

in Article 122, the first paragraph is amended as follows: 

(a) 

in the introductory sentence, ’26 May 2020’ is replaced by ’26 May 2021’; 

(b) 

the following indent is added:  

“–  Article  11(13)  of  Directive  93/42/EEC  and  Article  9(9)  of  Directive 
90/385/EEC  which  are  repealed  with  effect  from  [insert  date  –  date  of  entry 
into force of this Regulation]”;  

(8) 

Article 123 is amended as follows: 

(a) 

in paragraph 2, ‘26 May 2020’ is replaced by ‘26 May 2021’, 

(b)  paragraph 3 is amended as follows: 

(i) 

in point (a), ‘26 May 2020’ is replaced by ‘26 May 2021’, 

(ii) 

in the first sentence of point (d), ‘26 May 2020’ is replaced by ‘26 May 
2021’, 

(iii)  point (f) is replaced by the following: 

‘(f)  Article 27(4) shall apply to class IIa and class IIb devices from 26 

May 2023 and to class I devices from 26 May 2025;’, 

(iv)  point (g) is replaced by the following: 

‘(g)  with  regard  to  reusable  devices  that  are  required  to  bear  the  UDI 

carrier on the device itself, Article 27(4) shall apply to:  

(i) 

implantable devices and class III devices from 26 May 2023; 

(ii) 

class IIa and class IIb devices from 26 May 2025; 

(iii)  class I devices from 26 May 2027;’, 

(v) 

the following point (j) is added:  

“(j)  Article 59 shall apply from [insert date – date of entry into force of 

this Regulation]’;  

(9) 

in point (h) of point 5.1 of Annex IX,’26 May 2020’ is replaced by ’26 May 2021’.  

This Regulation shall enter into force on the day of its publication in the Official Journal of 
the European Union. 

Article 2 

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

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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