Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
Date: 2023-01-06
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EC conformity marking, market approval, marketing standard, medical device, medical diagnosis, public health, quality standard, safety standard, security of supply, single market

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   EUROPEAN COMMISSION  Brussels, 6.1.2023  COM(2023) 10 final 2023/0005 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (Text with EEA relevance)  
 
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EXPLANATORY MEMORANDUM 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 
Regulation  (EU)  2017/745  (MDR)1  and  Regulation  (EU)  2017/746  (IVDR)2  of  the 
European Parliament and of the Council establish a reinforced regulatory framework 
for  medical  devices  and  in  vitro  diagnostic  medical  devices.  Their  objectives  are  a 
high level of protection of health for patients and users and the smooth functioning of 
the  internal  market  for  these  products.  To  achieve  these  objectives  and,  in  light  of 
issues  identified  with  the  previous  regulatory  framework,  the  Regulations  set  out  a 
more  robust  system  of  conformity  assessment  to  ensure  the  quality,  safety,  and 
performance of devices placed on the EU market.  
The MDR  has been applicable since 26 May 20213. The transition  period  provided 
for in Article 120(3) will end on 26 May 2024. 

The  IVDR has been applicable since 26 May 2022.  In January 2022, the  European 
Parliament  and  the  Council  adopted  a  staggered  extension  of  its  transition  period, 
ranging  from  26  May  2025  for  high  risk  in  vitro  diagnostics  to  26  May  2027  for 
lower risk in vitro diagnostics, and to 26 May 2028 for certain provisions concerning 
devices manufactured and used in health institutions4. 

Despite considerable progress over the past years, the overall capacity of conformity 
assessment (‘notified’) bodies remains insufficient to carry out the tasks required of 
them.  In  addition,  many  manufacturers  are  not  sufficiently  prepared  to  meet  the 
strengthened  requirements  of  the  MDR  by  the  end  of  the  transition  period.  This  is 
threatening the availability of medical devices on the EU market. 

At  present,  36  notified  bodies  are  designated  under  Regulation  (EU)  2017/745. 
Further  26  applications  for  designation  as  notified  body  are  currently  being 
processed; three of them are at an advanced stage5.  

In  October  2022,  notified  bodies  reported  they  had  received  altogether  8,120 
applications  from  manufacturers  for  certification  under  the  MDR  and  had  issued 
1,990 certificates in accordance with the MDR. According to an estimation presented 

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). 
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). 
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)  had  postponed  the  date  of  application  of  Regulation  (EU) 
2017/745 from 26 May 2020 to 26 May 2021 due to the COVID-19 outbreak and the associated public 
health crisis. 
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 9, 28.1.2022, p. 3). 
In  those  three  cases,  the  joint  assessment  team  has  already  reviewed  the  applicants’  corrective  and 
preventive action plan. The length of the overall designation process varies considerably from case to 
case. Based on data from December 2021, the average length of the overall process was 842 days for a 
designation in accordance with the MDR. 

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by  notified  bodies  to  the  Medical  Device  Coordination  Group  (MDCG)6  on  17 
November  2022,  the  number  of  certificates  issued  by  May  2024  may  reach  around 
7,000 if the current rate of certificate issuance remains the same with no changes to 
current  conditions.  Notified  bodies  estimate  that  the  transition  of  all  Directives’ 
certificates to MDR certificates could possibly be completed by December 20277. 

Source: European Commission, based on data provided by 30 notified bodies in October 2022. 

This  is  in  stark  contrast  to  21,376  valid  certificates  issued  under  Council  Directive 
90/385/EEC on active implantable medical devices (AIMDD)8 and Council Directive 
93/42/EEC  on medical  devices (MDD)9 that will  expire  between January  2023 and 
26 May 2024. Of those 21,376 certificates, 4,311 certificates will expire in 2023 and 
17,095  certificates  will  expire  in  the  first  five  months  of  2024.  Of  note,  3,509 
certificates  issued  under  the  AIMDD  or  MDD  have  already  expired  between  May 
2021 and December 2022. 

Year of expiry 

Number of expired/expiring certificates 
issued under Council Directives 
90/385/EEC and 93/42/EEC 

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The  MDCG  has  been  established  by  Article  103  of  Regulation  (EU)  2017/745.  It  is  composed  of 
representatives  appointed  by  Member  States  and  chaired  by  a  representative  of  the  Commission.  The 
MDCG is listed in the Commission’s register of expert groups with the code X03565.  
Based  on  the  results  of  a  survey  among  notified  bodies  conducted  end  of  November/beginning  of 
December  2022;  the  respondents  represent  notified  bodies  that  have  issued  around  80%  of  all 
certificates  issued  under  Council  Directives  90/385/EEC  and  93/42/EEC  that  were  valid  in  October 
2022. This estimation does not take into account the number of first MDR certification of devices for 
which no certificates have been issued under Council Directives 90/385/EEC and 93/42/EEC and which 
require notified body involvement under the MDR. 
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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2021 (from 26 May) 

2022 

2023 

2024 (until 26 May 2024) 

1,139 

2,370 

4,311 

17,095 

Source: European Commission, based on data provided by notified bodies in 2021 and 2022.  

After  the  expiry  of  the  certificates  issued  under  the  Directives  and  without  a  valid 
MDR certificate, manufacturers are no longer allowed to place these medical devices 
on  the  EU  market.  This  may  cause  shortages  of  medical  devices,  putting  patient 
safety at risk. It is also likely to have a significant negative impact on innovation and 
business  activity  in  the  medical  technology  sector  within  the  EU.  The  situation  is 
exacerbated by the impact of the COVID-19 pandemic on clinical investigations, on-
site  audits  and  global  supply  chains,  on  which  Russia’s  war  of  aggression  against 
Ukraine is having a further negative impact. 

The  overall  goal  of  the  proposed  amendments  is  to  maintain  patients’  access  to  a 
wide range of medical devices while ensuring the transition to the new framework. 
The extension will be staggered depending on the risk class of the device, i.e. until 
December 2027 for devices with a higher risk and until December 2028 for medium 
and lower risk devices. 

This proposal thus aims to extend the current transition period  laid down in Article 
120 of the MDR, based on certain conditions, so that only devices that are safe and 
for  which  manufacturers  have  already  taken  steps  to  transition  to  the  MDR  will 
benefit from the additional time. This would give manufacturers and notified bodies 
more time to conduct the conformity assessment procedures in accordance with  the 
MDR,  if  those  conditions  are  fulfilled.  It  also  proposes  to  delete  the  ‘sell-off’ 
deadline in the relevant MDR and IVDR provisions, i.e. the end date for the further 
making  available  of  devices  which  are  placed  on  the  market  before  or  during  the 
transition period and which are still in the supply chain when the extended transition 
period is over. This would prevent unnecessary disposal of safe medical devices that 
are already on the market but not yet with the final user. 

The  extension  of  the  transition  period  is  complemented  by  an  extension  of  the 
validity of certificates issued under the previous Council Directives 90/385/EEC and 
93/42/EEC  for  the  devices  benefiting  from  the  extended  transition  period.  Also  the 
validity  of  certificates  that  have  already  expired  since  26  May  2021  would  be 
extended, subject to certain conditions.  

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Consistency with existing policy provisions in the policy area 

The  proposal  is  coherent  with  existing  policy  provisions  as  well  as  on-going  non-
legislative actions, which will complement the proposed amendment. On 25 August 
2022, the MDCG endorsed its position paper MDCG 2022-1410. The paper lays out 
19 non-legislative actions with a view to enhancing notified body capacity, access to 
notified  bodies  and  manufacturers’  preparedness  and  thereby  support  a  successful 
transition  to  the  MDR  and  IVDR.  Several  of  the  actions  listed  in  MDCG  2022-14 

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MDCG 2022-14 MDCG position paper Transition to the MDR and IVDR - Notified body capacity and 
availability of medical devices and IVDs (August 2022). 

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have already been implemented, such as a MDCG position paper on hybrid audits11, 
new MDCG guidance on appropriate surveillance12, and a revision of MDCG 2019-
6, removing obstacles to the employment of qualified personnel by notified bodies13. 

On  1  December  2022,  the  Commission  adopted  two  delegated  acts  deferring  the 
timing  of  the  first  complete  re-assessment  of  notified  bodies14.  This  is  expected  to 
free capacities both for designating authorities and notified bodies.  

Work  is  ongoing  to  implement  the  remaining  actions  listed  in  MDCG  2022-14,  as 
they remain important also if the transition period is extended. 

Further  actions  to  support  implementation  of  the  two  Regulations  are  also  (co-
)funded under the 2022 and 2023 work programmes of the EU4Health Programme15. 
On 9 December 2022, the MDCG issued its position paper MDCG 2022-1816 which 
sets out a uniform approach of competent authorities to applying market surveillance 
measures to bridge the gap between the expiry of MDD or AIMDD certificates and 
the issuance of MDR certificates. That approach is meant to be a temporary measure 
until  the  legislative  changes  in  this  proposal  take  effect.  It  contributes  to  avoiding 
disruption of supply of medical devices on the EU market. However, having regard 
to  the  number  of  certificates  expiring  in  2023  and  2024,  it  is  not  considered  a 
sustainable solution for addressing the expected bottleneck of expiring certificates by 
26 May 2024. 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

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

MDCG 2022-17 MDCG position paper on ‘hybrid audits’ (December 2022). 
MDCG  2022-15  Guidance  on  appropriate  surveillance  regarding  the  transitional  provisions  under 
Article  110  of  the  IVDR  with  regard  to  devices  covered  by  certificates  according  to  the  IVDD 
(September  2022);  MDCG  2022-4  rev.  1  Guidance  on  appropriate  surveillance  regarding  the 
transitional  provisions  under  Article  120  of  the  MDR  with  regard  to  devices  covered  by  certificates 
according to the MDD or the AIMDD (December 2022). 
MDCG 2019-6 Rev.4 Questions and answers: Requirements relating to notified bodies (October 2022). 
Commission Delegated Regulation (EU) …/... of 1.12.2022 amending Regulation (EU) 2017/745 of the 
European Parliament and of the Council as regards the frequency of complete re-assessments of notified 
bodies,  C(2022)  8640,  and  Commission  Delegated  Regulation  (EU)  …/...  of  1.12.2022  amending 
Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of 
complete  re-assessments  of  notified  bodies,  C(2022)  8649.  The  delegated  acts  are  available  in  the 
interinstitutional register of delegated acts and are subject to a three months scrutiny procedure by the 
European Parliament and the Council. 
E.g. under the 2022 EU4Health Work Programme: a call for proposals aimed to foster capacity-building 
of existing and new notified bodies, to facilitate access of small and medium-sized enterprises (SMEs) 
and first-time applicants to notified bodies and to increase preparedness of manufacturers (see HS-g-22-
19.03),  various actions supporting the implementation of  Regulations on  medical  devices and  in vitro 
diagnostic medical devices (see HS-p-22-19.04, 06, 07, 08, 09, 10 and 11) and direct grants to Member 
States’  authorities:  reinforced  market  surveillance  of  medical  devices  and  in  vitro  diagnostic  medical 
devices  (HS-g-22-19.01).  Under  the  2023 EU4Health  Programme:  support  to  the  technical  secretariat 
for  Notified  Bodies  Coordination  Group  (see  HS-p-23-63)  and  call  for  proposals  for  a  program  on 
orphan medical devices, in particular targeting paediatric patients (see HS-g-23-65). 
MDCG  2022-18  MDCG  position  paper  on  the  application  of  Article  97  MDR  to  legacy  devices  for 
which the MDD or AIMDD certificate expires before the issuance of a MDR certificate. 

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Subsidiarity 

According to the principle of subsidiarity, EU action may only be taken if the aims of 
the envisaged measure cannot be achieved by Member States alone. The legislation 
being  amended  was  adopted  at  EU  level  in  line  with  the  subsidiarity  principle  and 
any amendment must be made through an act adopted by the EU legislators. In the 
case  of  the  current  proposal  for  an  amendment,  EU  action  is  required  to  avoid 
disruption in the supply of devices across the EU, to ensure the smooth functioning 
of the internal market, and to ensure a high level of health protection for patients and 
users. 

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Proportionality 

The proposed EU action is necessary to avert the risk of shortages of medical devices 
across the EU. The proposed amendments aim to ensure that the intended purpose of 
the  MDR  and  IVDR  can  be  attained.  That  purpose  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  these  products.  The  proposal 
maintains  the  objective  of  both  Regulations  to  ensure  a  high  level  of  safety  and 
performance  of  devices  by  enhancing  their  oversight  by  notified  bodies.  It  only 
provides for the necessary additional time to achieve this objective. The proposal is 
proportionate in that it aims to address the identified issue, i.e. that due to shortage of 
notified  body  capacity  and  insufficient  preparedness  among  manufacturers  a  large 
number of existing devices may disappear from the market. Therefore, the proposed 
amendments  to  the  MDR  are  limited  to  allowing  a  gradual  phase-in  of  the 
requirements, limited to ‘legacy’ devices that need notified body involvement in the 
conformity assessment, without altering the substance of those requirements, and the 
deletion  of  the  ‘sell-off’  deadline.  The  amendment  of  the  IVDR  is  limited  to  the 
deletion of the ‘sell-off’ deadline in order to be consistent with the proposed change 
in the MDR. The Commission proposes to differentiate between higher risk devices 
(i.e. class  III  and  class  IIb  implantable) and lower  risk devices  (i.e.  other class  IIb, 
class IIa and class Im, Is, Ir17), with shorter transition periods for higher risk devices 
and longer periods for lower risk ones. This approach aims to balance the available 
notified body capacity and the level of manufacturers’ preparedness with high level 
of public health protection. 

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Choice of the instrument 

The proposed act is a Regulation to be adopted by the European Parliament and the 
Council, given that the acts to be amended are Regulations adopted by the European 
Parliament and the Council. 

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RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Given the urgent nature of this proposal, it is not accompanied by a dedicated impact 
assessment.  An  impact  assessment  was  already  carried  out  when  preparing  the 
proposals for the MDR  and the IVDR and this proposal does not alter the MDR or 
IVDR in substance and does not impose new obligations on the concerned parties. It 

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Class Im means class I devices with a measuring function; class Is means class I devices that are placed 
on the market in sterile condition; class Ir means class I devices that are reusable surgical instruments. 

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primarily  aims to  amend the transitional provisions, allowing for  additional time to 
transition to the MDR’s requirements to avoid shortages. The need to act quickly to 
ensure  certainty  ahead  of  the  Regulation’s  current  end  of  transition  period  did  not 
allow  for  a  broad  public  consultation.  The  Commission  therefore  collected  the 
necessary input from Member States and stakeholders through targeted exchanges. 

The  initiative  aims  to  assure  that  patients  throughout  Europe  have  access  to  safe 
medical  devices.  As  more  and  more  certificates  will  expire  before  the  May  2024 
deadline, the Commission has committed to adopt a proposal in January 2023. This is 
backed  up  by  urgent  calls  from  the  European  Parliament,  Member  States  and 
stakeholders,  namely  healthcare  professionals,  patients,  academia,  scientific  bodies, 
industry  and  notified  bodies.  Input  from  Member  States  and  stakeholders  has  been 
sought through targeted interaction, mainly in the framework of the Medical Device 
Coordination Group (MDCG) with meetings on 24-25 August, 24-25 October and 17 
November 2022, dedicated to capacity and preparedness issues.  Following a debate 
in  the  European  Parliament  on  24  November  2022  (oral  question  O-43/2022),  the 
European Parliament’s  Committee on Environment,  Public Health and  Food Safety 
requested  an  urgent  targeted  amendment  in  a  letter  of  5  December  2022.  An 
exchange of views with  Member States  took place on 9 December 2022 during the 
EPSCO Health Council18; almost all Member States took the floor and supported the 
urgent adoption of a targeted amendment of the MDR and IVDR as suggested by the 
Commission. 

The Commission will continue to closely monitor the developments and the impact 
of the proposed amendments on the market. It will also consult with the MDCG and 
stakeholders about the need for complementary actions. 

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BUDGETARY IMPLICATIONS 

The proposed action has no budgetary implications. 

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OTHER ELEMENTS 

Detailed explanation of the specific provisions of the proposal 

Article  1  contains  the  proposed  amendments  to  Article  120(2),  (3)  and  (4)  and  to 
Articles  122  and  123  of  the  MDR.  Article  2  contains  the  amendments  to  Article 
110(4) and to Article 112 of the IVDR. 

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Article 1(1), point (a), of the proposal – extension of the validity of certificates 

This  provision  amends  Article  120(2)  MDR.  It  extends  the  validity  of  certificates 
issued  under  Council  Directives  90/385/EEC  or  93/42/EEC  that  were  valid  on  the 
day of the MDR’s date of application (26 May 2021) and have not been withdrawn 
by  a  notified  body.  The  extension  is  directly  applicable,  so  that  notified  bodies  are 
not  required  to  change  the  date  on  the  individual  certificates.  The  length  of  the 
extension  of  the  certificate’s  validity  corresponds  to  the  length  of  the  extended 
transition period laid down in the proposed Article 120(3a) to (3c) of the MDR. As 
regards certificates that have already expired when the proposed amendment comes 
into force, the extension would be subject to the condition that, at the moment of the 
expiry,  the  manufacturer  has  signed  a  contract  with  a  notified  body  for  the 

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See Commission information note circulated as Council document 15520/22 of 6.12.2022. 

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conformity  assessment  of  the  device  in  question.  Alternatively,  if  no  such  contract 
has  been  signed  at  the  moment  when  the  certificate  expired,  a  national  competent 
authority may have granted a derogation from the applicable conformity assessment 
procedure  in  accordance  with  Article  59  of  the  MDR  or  have  required  the 
manufacturer to carry out the conformity assessment procedure within a specific time 
period in accordance with Article 97 of the MDR.    

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Article 1(1), point (b), of the proposal – extension of the transition period 

This  provision  amends  Article  120(3)  MDR.  Due  to  the  length  of  the  provision, 
paragraph  3  is  replaced  by  paragraphs  3a  to  3g.  The  transition  period  is  extended 
from  26  May  2024  until  31  December  2027  for  higher  risk  devices  (class  III  and 
class  IIb  implantable  devices  except  certain  devices  for  which  the  MDR  provides 
exemptions, given that these devices are considered to be based on well established 
technologies) and until 31 December 2028 for medium and lower risk devices (other 
class IIb devices and class IIa, class Im, Is and Ir devices). 

In the same way as  the current Article 120(3) MDR, the extended transition period 
applies only to ‘legacy devices’, i.e. those covered by a certificate or declaration of 
conformity  issued  under  Council  Directives  90/385/EEC  or  93/42/EEC  before  26 
May 2021. 

Moreover,  the  application  of  the  extended  transition  period  is  subject  to  several 
cumulative conditions, which are: 

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● 

● 

the devices  must  continue to  comply with  Directive 90/385/EEC or Directive 
93/42/EEC, as applicable. This condition is already part of the current Article 
120(3) MDR; 

the  devices  do  not  undergo  significant  changes  in  the  design  and  intended 
purpose. This condition is already part of the current Article 120(3) MDR; 

the  devices  do  not  present  an  unacceptable  risk  to  the  health  or  safety  of 
patients, users or other persons, or to other aspects of the protection of public 
health.  The  concept  of  “unacceptable  risk  to  health  and  safety”  is  set  out  in 
Article 94 and 95  of the  MDR.  No systematic check of the device’s safety is 
required, as devices covered by a certificate issued under the Directives will be 
under  ‘appropriate  surveillance’  by  the  body  that  issued  the  certificate  or  a 
notified  body  designated  under  the  MDR.  Where,  as  part  of  their  market 
surveillance  activities,  a  competent  authority  finds  that  a  device  presents  an 
unacceptable risk to the health or safety of patients, users or other persons, or 
to other aspects of the protection of public health, the transition period ceases 
to apply for that device; 

no  later  than  26  May  2024,  the  manufacturer  has  put  in  place  a  quality 
management system (QMS) in accordance with Article 10(9) of the MDR. This 
condition  aims  to  ensure  that  manufacturers  gradually  move  towards  full 
compliance  with  the  MDR  requirements.  No  specific  attestation,  i.e.  no  self-
declaration  nor  verification  of  the  appropriateness  of  the  QMS  by  a  notified 
body,  is  required  at  this  stage.  However,  by  submitting  an  application  for 
conformity  assessment 
the 
manufacturer implicitly confirms that its QMS is in compliance with the MDR; 

to  a  notified  body  (see  next  condition), 

● 

no later than 26 May 2024, the manufacturer, or its authorised representative, 
has lodged a formal application in accordance with Annex VII, Section 4.3, of 
the MDR for conformity assessment in respect of a ‘legacy device’ covered by 

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a Directive’s certificate or declaration of conformity, or in respect of a device 
intended  to  substitute  that  device  under  the  MDR,  and  no  later  than  26 
September 2024 the notified body and the manufacturer have signed a written 
agreement in accordance with Annex VII, Section 4.3, of this Regulation. This 
condition  aims  to  ensure  that  only  devices  that  the  manufacturer  intends  to 
transition  to  the  MDR  will  benefit  from  the  extended  transition  period.  The 
extension should, however, also apply to ‘legacy devices’ that the manufacturer 
intends  to  replace  by  a  ‘new’  device  for  which  it  applies  for  conformity 
assessment  before  26  May  2024.  In  this  way,  unnecessary  applications  for 
certification of devices that  will in  any  case be  phased out  and  replaced by  a 
new generation of devices will be avoided, whist keeping the existing models 
available until the end of the transition period. 

The  devices  covered  by  a  certificate  issued  under  the  AIMDD  or  MDD  remain 
subject  to  ‘appropriate surveillance’ by the notified body that issued the certificate. 
Alternatively, the manufacturer can agree with a notified body designated under the 
MDR  that  the  latter  becomes  responsible  for  the  surveillance.  At  the  latest  by  the 
date when the written agreement between the manufacturer and the notified body for 
conformity assessment in accordance with the MDR needs to be signed, that notified 
body would by default become responsible for the appropriate surveillance.  

The  amendment  introduces  a  transition  period  until  26  May  2026  also  for  class  III 
custom-made implantable devices, which are currently not covered by Article 120(3) 
MDR.  While  manufacturers  of  class  III  implantable  custom-made  devices  are 
required to comply with all applicable MDR requirements since 26 May 2021, they 
will  now  be  given  more  time  to  obtain  certification  of  their  quality  management 
system by a notified body. Also in this case, the transition period only applies if the 
manufacturer has lodged an application before 26 May 2024 resulting in the signing 
of a contract with the notified body before 26 September 2024. 

Article 1(1), point (c), of the proposal – deletion of the ‘sell-off’ deadline in the 
MDR 

This  provision  deletes  the  current  ‘sell-off’  date  (27  May  2025)  in  Article  120(4) 
MDR.  Consequently,  devices  placed  on  the  market  before  the  end  of  the  transition 
period can be made further available on the market without a legal time restriction. 

Article 1(2) and (3) of the proposal – adaptation of Articles 122 and 123 MDR 

This  provision  adapts  Articles  122  and  123  MDR  to  reflect  the  extended  transition 
period and the deletion of the ‘sell-off’ deadline. 

Article 2(1) of the proposal – deletion of the ‘sell-off’ deadlines in the IVDR 

This provision deletes the current ‘sell-off’ dates (25 May 2025 to 26 May 2028) in 
Article 110(4) IVDR. Consequently, devices placed on the market before the end of 
the transition period laid down in Article 110(3) IVDR can be made further available 
on the market without a legal time restriction. 

• 

• 

• 

• 

Article 2(2) of the proposal – adaptation of Article 112 IVDR 

This  provision  adapts  Article  112  IVDR  to  reflect  the  deletion  of  the  ‘sell-off’ 
deadlines. 

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2023/0005 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional 
provisions for certain medical devices and 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), point (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) 

Regulations  (EU)  2017/7451  and  (EU)  2017/7462  of  the  European  Parliament  and  of 
the Council establish a new regulatory framework to ensure the smooth functioning of 
the internal market as regards medical devices and in vitro diagnostic medical devices, 
taking as a base a high level of protection of health for patients and users. At the same 
time, Regulations (EU) 2017/745 and (EU) 2017/746 set high standards of quality and 
safety  for  medical  devices  and  in  vitro  diagnostic  medical  devices  in  order  to  meet 
common  safety  concerns  as  regards  such  devices.  Furthermore,  both  Regulations 
significantly reinforce key elements of the previous regulatory framework in Council 
Directives  90/385/EEC3  and  93/42/EEC4  and  Directive  98/79/EC  of  the  European 
Parliament and of the Council5, such as the supervision of notified bodies, conformity 
assessment  procedures,  clinical  evidence  requirements,  vigilance  and  market 
surveillance,  whilst  introducing  provisions  ensuring  transparency  and  traceability 
regarding medical devices and in vitro diagnostic medical devices. 

1 

2 

3 

4 
5 

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). 
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). 
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). 
Directive  98/79/EC  of  the  European  Parliament  and  of  the  Council  of  27  October  1998  on  in  vitro 
diagnostic medical devices (OJ L 331, 7.12.1998, p. 1). 

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(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

Due to the impact of the COVID-19 pandemic, the date of application of Regulation 
(EU) 2017/745 has been postponed by one year to 26 May 2021 by Regulation (EU) 
2020/561  of the European Parliament and of the Council6, while the  date of 26 May 
2024  was  maintained  as  end  of  the  transition  period  by  which  certain  devices  that 
continue to comply with Directive 90/385/EEC or Directive 93/42/EEC may be placed 
on the market or put into service. 

Also due to the impact of the COVID-19 pandemic, the transition period provided for 
in Regulation (EU) 2017/746 has already been extended by Regulation (EU) 2022/112 
of the European Parliament and of the Council7.      

Despite the steady increase in the number of notified bodies designated in accordance 
with  Regulation  (EU)  2017/745,  the  overall  capacity  of  notified  bodies  is  still  not 
sufficient to ensure the conformity assessment of the large number of devices covered 
by certificates issued under Directive 90/385/EEC or  Directive  93/42/EEC  before 26 
May  2024.  It  appears  that  a  large  number  of  manufacturers,  especially  small  and 
medium-sized  enterprises,  are  not  sufficiently  prepared  to  demonstrate  compliance 
with  the  requirements  of  Regulation  (EU)  2017/745,  taking  into  account  also  the 
complexity of those new requirements. Therefore, it is very likely that many devices 
that  may  be  placed  on  the  market  in  accordance  with  the  transitional  provisions 
provided for in Regulation (EU) 2017/745 are not going to be certified in accordance 
with that Regulation before the end of the transition period, which leads to the risk of 
shortages of medical devices in the Union. 

In light of reports from healthcare professionals about the imminent risk of shortages 
of devices, it is necessary, as a matter of urgency, to extend the validity of certificates 
issued  under  Directives  90/385/EEC  and  93/42/EEC  and  to  extend  the  transition 
period during which devices that are in conformity with those Directives can be placed 
on  the  market.  The  extension  should  be  sufficiently  long  to  give  notified  bodies  the 
time needed to carry out the conformity assessments required of them. The extension 
aims at ensuring a high level of public health protection, including patient safety and 
an  avoidance  of  shortages  of  medical  devices  needed  for  the  smooth  functioning  of 
health services, without lowering current quality and safety requirements. 

The extension should be subject to certain conditions to ensure that only devices that 
are  safe  and  for  which  the  manufacturers  have  taken  steps  to  transition  towards 
compliance with Regulation (EU) 2017/745 will benefit from the additional time. 

To  ensure  progressive  transition  to  Regulation  (EU)  2017/745,  the  appropriate 
surveillance regarding devices benefiting from the transition period should eventually 
pass  over  from  the  body  that  has  issued  the  certificate  in  accordance  with  Directive 
90/385/EEC  or  Directive  93/42/EEC  to  a  notified  body  designated  under  Regulation 
(EU) 2017/745.  For reasons of legal  certainty it  should be provided that  the notified 
body should not  be responsible for  conformity assessment and surveillance activities 
carried out by the outgoing body.        

6 

7 

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). 
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). 

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(8) 

(9) 

As  regards  the  period  of  time  needed  to  allow  manufacturers  and  notified  bodies  to 
carry out the conformity assessment in accordance with Regulation (EU) 2017/745 of 
medical devices that had been CE marked in accordance with Directive 90/385/EEC or 
Directive  93/42/EEC,  a  balance  should  be  struck  between  the  limited  available 
capacity of notified bodies and ensuring a high level of patient safety and public health 
protection.  Therefore,  the  length  of  the  transition  period  should  depend  on  the  risk 
class  of  the  medical  devices  concerned,  so  that  the  period  is  shorter  for  devices 
belonging to a higher risk class and longer for devices belonging to a lower risk class. 

Contrary  to  Directives  90/385/EEC  and  93/42/EEC,  Regulation  (EU)  2017/745 
requires the involvement of a notified body in the conformity assessment of class III 
custom-made  implantable  devices.  Having  regard  to  insufficient  notified  body 
capacity  and  the  fact  that  manufacturers  of  custom-made  devices  are  often  small  or 
medium-sized enterprises that did not have access to a notified body under Directives 
90/385/EEC and 93/42/EEC, a transition period should be provided during which class 
III custom-made implantable devices may be placed on the market or put into service 
without a certificate issued by a notified body.     

(10)  Article  120(4)  of  Regulation  (EU)  2017/745  and  Article  110(4)  of  Regulation  (EU) 
2017/746  prohibit  the  further  making  available  of  devices  which  are  placed  on  the 
market by the end of the applicable transition period and which are still in the supply 
chain one year after the end of that transition period. To prevent unnecessary disposal 
of  safe  medical  devices  and  in  vitro  diagnostic  medical  devices  that  are  still  in  the 
supply  chain,  thus  adding  to  the  imminent  risk  of  shortages  of  devices,  such  further 
making available of devices should be unlimited in time. 

(11)  The adoption of this Regulation takes place  due to exceptional circumstances arising 
from  an  imminent  risk  of  shortages  of  medical  devices  and  the  associated  risk  of  a 
public  health  crisis.  In  order  to  attain  the  intended  effect  of  the  amendments  to 
Regulations  (EU)  2017/745  and  (EU)  2017/746 and  to  ensure  availability  of  devices 
whose certificates have  already  expired or are due to  expire before 26  May 2024, to 
provide  legal  certainty  for  economic  operators  and  healthcare  providers,  and  for 
reasons of consistency as regards the amendments to both Regulations, it is necessary 
for this Regulation to  enter into force as soon as possible. For the same reasons it is 
also  considered  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, 

HAVE ADOPTED THIS REGULATION: 

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

(1) 

Article 120 is amended as follows: 

Article 1 

(a) 

in paragraph 2, the second subparagraph is replaced by the following: 

issued  by  notified  bodies 

‘Certificates 
in  accordance  with  Directives 
90/385/EEC and 93/42/EEC as from 25 May 2017 that were valid on 26 May 
2021 and that have not been withdrawn afterwards shall remain valid after the 
end of the period indicated on the certificate until the dates set out in paragraph 
3b for the relevant risk class of the devices. Certificates referred to in the first 

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sentence  that  have  expired  before  [OP  please  insert  the  date  –  date  of  entry 
into force of this Regulation] shall be considered to be valid until the dates set 
out in paragraph 3b only if one of the following conditions is fulfilled:  

(a) 

(b) 

before  the  date  of  expiry  of  the  certificate,  the  manufacturer  and  a 
notified  body  have  signed  a  written  agreement  in  accordance  with 
Section  4.3,  second  subparagraph,  of  Annex  VII  for  the  conformity 
assessment in respect of the device covered by the expired certificate or 
in respect of a device intended to substitute that device;  

a competent authority of a Member State has  granted a derogation from 
the  applicable  conformity  assessment  procedure  in  accordance  with 
Article  59(1)  or  has  required  the  manufacturer,  in  accordance  with 
Article  97(1),  to  carry  out  the  applicable  conformity  assessment 
procedure’; 

(b)  paragraph 3 is replaced by the following: 

‘3a. By way of derogation from Article 5 and provided the conditions set out in 
paragraph 3d of this Article are met, devices referred to in paragraphs 3b and 
3c of this Article may be placed on the market or put into service until the dates 
set out in those paragraphs. 

3b.  Devices  which  have  a  certificate  that  was  issued  in  accordance  with 
Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of 
paragraph  2  of  this  Article  may  be  placed  on  the  market  or  put  into  service 
until the following dates: 

(a) 

31  December  2027,  for  class  III  devices  and  for  class  IIb  implantable 
devices,  except  sutures,  staples,  dental  fillings,  dental  braces,  tooth 
crowns, screws, wedges, plates, wires, pins, clips and connectors; 

(b)  31  December  2028,  for  class  IIb  devices  other  than  those  covered  by 
point  (a),  for  class  IIa  devices,  and  for  class  I  devices  placed  on  the 
market in sterile condition or having a measuring function. 

3c.  Devices  for  which  the  conformity  assessment  procedure  pursuant  to 
Directive  93/42/EEC  did  not  require  the  involvement  of  a  notified  body,  for 
which the declaration of conformity was drawn up prior to 26 May 2021 and 
for  which  the  conformity  assessment  procedure  pursuant  to  this  Regulation 
requires  the  involvement  of  a  notified  body,  may  be  placed  on  the  market  or 
put into service until 31 December 2028. 

3d.  Devices  may  be  placed  on  the  market  or  put  into  service  until  the  dates 
referred  to  in  paragraphs  3b  and  3c  of  this  Article  only  if  the  following 
conditions are met: 

(a) 

those  devices  continue  to  comply  with  Directive  90/385/EEC  or 
Directive 93/42/EEC, as applicable; 

(b) 

there are no significant changes in the design and intended purpose; 

(c) 

the devices do not present an unacceptable risk to the health or safety of 
patients,  users  or  other  persons,  or  to  other  aspects  of  the  protection  of 
public health; 

(d)  no  later  than  26  May  2024,  the  manufacturer  has  put  in  place  a  quality 

management system in accordance with Article 10(9); 

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(e) 

no  later  than  26  May  2024,  the  manufacturer,  or  an  authorised 
representative,  has  lodged  a  formal  application  in  accordance  with 
Section 4.3, first subparagraph, of Annex VII for conformity assessment 
in respect of a device referred to in paragraphs 3b and 3c of this Article 
or in  respect  of  a  device  intended to  substitute  that device, and no later 
than  26  September  2024  the  notified  body  and  the  manufacturer  have 
signed  a  written  agreement  in  accordance  with  Section  4.3,  second 
subparagraph, of Annex VII. 

3e.  By  way  of  derogation  from  paragraph  3a,  the  requirements  of  this 
Regulation relating to post-market surveillance, market surveillance, vigilance, 
registration  of  economic  operators  and  of  devices  shall  apply  to  devices 
referred to in paragraphs 3b and 3c of this Article in place of the corresponding 
requirements in Directives 90/385/EEC and 93/42/EEC. 

3f.  Without  prejudice  to  Chapter  IV  and  paragraph  1  of  this  Article,  the 
notified  body  that  issued  the  certificate  referred  to  in  paragraph  3b  of  this 
Article  shall  continue  to  be  responsible  for  the  appropriate  surveillance  in 
respect  of  the  applicable  requirements  relating  to  the  devices  it  has  certified, 
unless  the  manufacturer  has  agreed  with  a  notified  body  designated  in 
accordance with Article 42 that the latter shall carry out that surveillance.  

No later than 26 September 2024, the notified body that has signed the written 
agreement  referred  to  in  paragraph  3d,  point  (e),  shall  be  responsible  for  the 
surveillance in respect of the devices covered by the written agreement. Where 
the written agreement covers a device intended to substitute a device which has 
a  certificate  that  was  issued  in  accordance  with  Directive  90/385/EEC  or 
Directive  93/42/EEC,  the  surveillance  shall  be  conducted  in  respect  of  the 
device that is being substituted.  

The  arrangements  for  the  transfer  of  the  surveillance  from  the  notified  body 
that  issued  the  certificate  to  the  notified  body  designated  in  accordance  with 
Article  42  shall  be  defined  in  an  agreement  between  the  manufacturer,  the 
notified body designated in accordance with Article 42 and, where practicable, 
the  notified  body  that  issued  the  certificate.  The  notified  body  designated  in 
accordance with Article 42 shall not be responsible for conformity assessment 
activities carried out by the notified body that issued the certificate.        

3g.  By  way  of  derogation  from  Article  5,  class  III  custom-made  implantable 
devices  may  be  placed  on  the  market  or  put  into  service  until  26  May  2026 
without  a  certificate  issued  by  a  notified  body  in  accordance  with  the 
conformity  assessment  procedure  referred  to  in  Article  52(8),  second 
subparagraph,  provided  that  no  later  than  26  May  2024,  the  manufacturer,  or 
the  authorised  representative  of  the  manufacturer,  has  lodged  a  formal 
application  in  accordance  with  Section  4.3,  first  subparagraph,  of  Annex  VII 
for the applicable conformity assessment, and no later than 26 September 2024 
the  notified  body  and  the  manufacturer  have  signed  a  written  agreement  in 
accordance with Section 4.3, second subparagraph, of Annex VII.’; 

(c) 

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 

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26  May  2021  pursuant  to  paragraphs  3a,  3b,  3c  and  3g  of  this  Article,  may 
continue to be made available on the market or put into service.’ 

(2) 

Article 122 is amended as follows: 

(1) 

in the first paragraph, the introductory wording is replaced by the following: 

‘Without  prejudice  to  Article  120(3a)  to  (3f)  and  (4)  of  this  Regulation,  and 
without prejudice to the obligations of the Member States and manufacturers as 
regards vigilance and to the obligations of manufacturers as regards the making 
available  of  documentation,  under  Directives  90/385/EEC  and  93/42/EEC, 
those Directives are repealed with effect from 26 May 2021, with the exception 
of:’; 

(2) 

the second paragraph is replaced by the following: 

‘As  regards  the  devices  referred  to  in  Article  120(3a)  to  (3f)  and  (4)  of  this 
Regulation,  the  Directives  referred  to  in  the  first  paragraph  shall  continue  to 
apply to the extent necessary for the application of those paragraphs.’; 

(3) 

In Article 123(3), point (d), the twenty-fourth indent is replaced by the following: 

‘- Article 120(3e).’. 

Regulation (EU) 2017/746 is amended as follows: 

(1) 

in Article 110, paragraph 4 is replaced by the following: 

Article 2 

‘4. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 
May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to 
paragraph 3 of this Article may continue to be made available on the market or put 
into service.’; 

(2) 

in Article 112, the second paragraph is replaced by the following: 

‘As  regards  the  devices  referred  to  in  Article  110(3)  and  (4)  of  this  Regulation, 
Directive 98/79/EC shall continue to apply to the extent necessary for the application 
of those paragraphs.’. 

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

Article 3 

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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