Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices
Date: 2024-01-23
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EC conformity marking, exchange of information, information system, market approval, medical device, medical diagnosis, public health, security of supply, single market

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   EUROPEAN COMMISSION  Brussels, 23.1.2024  COM(2024) 43 final 2024/0021 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain 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  (the  ‘Medical  Devices  Regulation’  (MDR))1  and 
Regulation  (EU)  2017/746  (the  ‘In  Vitro  Diagnostic  Medical  Devices  Regulation’ 
(IVDR))2  of  the  European  Parliament  and  of  the  Council  set  a  strengthened 
regulatory  framework  for  medical  devices  and  in  vitro  diagnostic  medical  devices 
(IVDs). Their objectives are a high level of protection of health for patients and users 
and the smooth functioning of the single market for these products. To achieve these 
objectives  and  to  address  issues  identified  with  the  previous  regulatory  framework, 
the Regulations set up a more robust system of conformity assessment to ensure the 
quality, safety and performance of devices placed on the EU market.  
The  MDR  has  applied  since  26 May 20213.  The  transitional  period  provided  for  in 
Article 120 has been extended by Regulation (EU) 2023/6074 and will end on either 
31 December 2027  or  31 December 2028,  depending  on  the  device’s  risk  class  and 
subject to certain conditions.  

The IVDR has applied since 26 May 2022. In January 2022, the European Parliament 
and the Council adopted a staggered extension of its transitional period, ranging from 
26 May 2025  for  high-risk  IVDs  to  26 May 2027  for  lower-risk  IVDs,  and  to 
26 May 2028  for  certain  provisions  concerning  devices  manufactured  and  used  in 
health institutions5. This extension was not subject to conditions similar to the ones 
laid down for medical devices by Regulation (EU) 2023/607.  

This proposal for targeted amendments addresses two urgent issues. Firstly, it aims 
to  further  extend  the  transitional  period  for  certain  IVDs  to  mitigate  the  risk  of 
shortages  of  these  products,  especially  of  high-risk  IVDs,  which  are  used,  for 
example, to test for infections in blood or organ donations or for blood grouping for 
transfusions.  

Secondly,  the  proposal  aims  to  enable  a  gradual  roll-out  of  the  electronic  systems 
integrated  into  the  European  database  on  medical  devices  (‘Eudamed’)  that  are 
finalised, instead of deferring the mandatory use of Eudamed until the last of the six 

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) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending 
Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical 
devices and in vitro diagnostic medical devices (OJ L 80, 20.3.2023, p. 24). 
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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modules  is  completed.  The  use  of  Eudamed  –  and  especially  its  systems  for  the 
registration  of  economic  operators,  devices  and  certificates  –  will  improve 
transparency  and  provide  information  on  devices  on  the  EU  market,  helping  to 
monitor the availability of devices.  

In  addition,  the  proposal  aims  to  impose  a  requirement  on  manufacturers  to  give 
prior  notice  before  interrupting  the  supply  of  certain  critical  medical  devices  and 
IVDs.  

a)  Transition of devices to the IVDR   

There is a wide variety of IVDs, including HIV tests for blood donation screening or 
individual diagnosis, cancer tests, pregnancy tests or SARS-CoV-2 tests. Around two 
thirds  of  all  clinical  decisions  are  based  on  information  provided  by  IVDs6.  It  is 
paramount to ensure both a high level of safety and performance of IVDs and their 
availability to healthcare systems.  

The IVDR has introduced very substantial changes to the regulatory framework for 
IVDs  with  significant  resource  and  capacity  implications.  According  to  the  IVDR, 
IVDs are classified into different risk classes from class A (low risk) to class D (high 
risk). One of the most profound changes is the increased involvement of independent 
conformity assessment bodies (‘notified bodies’) in conformity assessment, in a way 
that  is  proportionate  to  the  device’s  risk  class.  Under  the  previous  Directive 
98/79/EC7, only a relatively small number of high-risk devices, i.e. about 8% of the 
more than 40 000 IVDs on the EU market covered by the Directive8, were subject to 
scrutiny  by  notified  bodies.  In  October  2022,  there  were  1 551  valid  certificates 
issued  by  notified  bodies  under  Directive  98/79/EC9.  Some  of  these  have  already 
expired (38 in 2022 and 165 in 2023); 482 certificates will expire in 2024 and 866 
certificates will expire in 2025 (by 26 May)10.  

Under the IVDR, around 80% of IVDs will be subject to scrutiny by notified bodies, 
most of them for the first time8. As a consequence, the number of certificates under 
the IVDR is expected to be significantly higher than the number of certificates issued 
under Directive 98/79/EC. The relationship  between the number of devices  and the 
number  of  certificates  covering  them  is  complex,  so  no  precise  calculation  can  be 
made, but numbers in the order of 15 000 certificates and higher could reasonably be 
expected. More than 1 000 devices are in the highest risk class (class D)11. Under the 
IVDR,  these  devices  require  the  issuance  of  both  a  quality  management  system 
certificate and an individual device technical documentation assessment certificate.  

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in  May 

Rohr,  Ulrich-Peter,  et  al.,  ‘The  Value  of  In  Vitro  Diagnostic  Testing  in  Medical  Practice:  A  Status 
Report’, PLOS ONE 11(3): e0149856 (2016). 
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). 
MedTech  Europe  Survey  Report  –  Analysing  the  availability  of  In  vitro  Diagnostic  Medical  Devices 
(IVDs) 
applies, 
https://www.medtecheurope.org/resource-library/medtech-europe-survey-report-analysing-the-
availability-of-in-vitro-diagnostic-medical-devices-ivds-in-may-2022-when-the-new-eu-ivd-regulation-
applies/. 
Based on data received from notified bodies in October 2022. 
Based on data received from notified bodies in October 2022. 
Transition 
https://www.medtecheurope.org/wp-content/uploads/2023/02/230220_public-report-ivdr-
survey_di35.pdf. 

the  IVD  Regulation  –  MedTech  Europe  Survey  Results 

for  October  2022, 

Regulation 

when 

2022 

IVD 

new 

EU 

the 

to 

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Those  figures  are  in  stark  contrast  to  the  low  number  of  certificates  already  issued 
and ongoing applications under the IVDR. In fact, the vast majority of IVDs have not 
yet  transitioned  to  the  IVDR.  As  of  end  of  October  2023,  manufacturers  had 
submitted 1 378 applications for conformity assessment under the IVDR, resulting in 
677  certificates  issued  by  notified  bodies  across  all  risk  classes.  For  class  D  IVDs, 
only 335 applications had been submitted and 117 certificates had been issued12.  

While  there  are  still  several  years  of  transitional  period  remaining  for  classes  C,  B 
and A sterile, the transitional period for class D devices ends on 26 May 2025. Given 
the  low  number  of  certificates  and  applications  for  class  D  IVDs,  and  the  long 
duration  of  the  conformity  assessment  process  as  explained  below,  there  is  a  high 
risk of shortages of many of these devices. Class D devices are used, for example, to 
test  for  infections  in  blood  or  organ  donations,  to  test  patients  for  life-threatening 
infectious diseases, or for blood grouping for transfusions. Therefore, there is a high 
risk of a public health crisis if there is a shortage of such devices.  

As  explained  above,  in  January  2022,  the  European  Parliament  and  the  Council 
adopted  a  staggered  extension  of  the  transitional  period  due  to  the  impact  of  the 
COVID-19  pandemic.  The  slow  rate  of  transition  has  made  this  extension 
insufficient.  The  reasons  are  multifaceted;  however,  they  are  underpinned  by  the 
far-reaching  nature  of  changes  introduced  by  the  IVDR  and  the  resulting  increased 
need for scientific, technical and regulatory expertise and capacity at all levels in the 
system, which require time to be built up. 
At present, only 12 notified bodies13 are designated under the IVDR, compared to 22 
notified bodies designated under Directive 98/79/EC (18 after the UK’s withdrawal 
from the EU). A further 8 applications for designation as notified body are currently 
in  progress.  The  staggering  of  the  transitional  periods  by  risk  class  in  2022  meant 
that  the  workload  on  notified  bodies  could  be  distributed  over  time,  and  provided 
relief to the sector14. Nevertheless, access to notified bodies has remained an issue, 
especially for small to medium-sized enterprises (SMEs)11.  

Notified bodies are also facing challenges due to the extensive changes introduced by 
the IVDR. They must apply new requirements for types of devices that they have not 
handled previously. The duration of the notified body’s assessment is affected by the 
often  insufficient  quality  of  manufacturers’  applications15.  As  of  July  2023,  the 
the  conformity  assessment  process  combining  quality 
average  duration  of 
management  system  and  technical  documentation  assessment  was  around  18 
months15. 

Thus,  the  overall  notified  body  capacity  in  the  EU  is  limited,  due  to  both  low 
numbers  of  notified  bodies  and  challenges  to  their  efficient  and  smooth  operation. 
Additional  transition  time  is  needed  to  help  address  this  persisting  problem.  More 

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Based on preliminary data received from notified bodies in December 2023. 
See  list  of  designated  notified  bodies  in  the  NANDO  (new  approach  notified  and  designated 
organisations) information system, EUROPA – European Commission – Growth – Regulatory policy - 
SMCS. 
The  MedTech  Europe  survey  indicates  that  ~91%  of  companies  report  having  benefited  from  the 
change in IVDR transitional periods in early 2022. Transition to the IVD Regulation – MedTech Europe 
Survey 
https://www.medtecheurope.org/wp-
content/uploads/2023/02/230220_public-report-ivdr-survey_di35.pdf. 
Notified bodies survey on certifications and applications, https://health.ec.europa.eu/system/files/2023-
11/md_nb_survey_certifications_applications_en.pdf. 

October 

Results 

2022, 

for 

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notified  bodies  will  be  designated  over  time  and  the  efficiency  in  processing 
applications  will  improve  as  both  manufacturers  and  notified  bodies  gain  more 
experience  with  the  IVDR.  In  the  short  term,  it  is  also  important  to  maintain  the 
staggering  of  transitional  periods  by  risk  class  to  avoid  a  bottleneck  at  the  level  of 
notified bodies.  

Furthermore,  it  appears  that  many  manufacturers  are  not  sufficiently  prepared  to 
demonstrate  compliance  with  the  requirements  of  the  IVDR.  This  may  be  due  to 
various  causes,  including  the  complexity  of  these  new  requirements,  lack  of 
experience of interaction with notified bodies, and the continuous development of the 
IVDR  framework,  such  as  ongoing  designation  of  notified  bodies,  and  for  class  D 
IVDs  adoption  of  common  specifications  and  designation  of  EU  reference 
laboratories.  Around  90%  of  medical  device  companies  are  SMEs16,  for  which 
managing the transition can be especially challenging. More and more tools are being 
put in place to support manufacturers, with particular attention to SMEs, including: 
(i)  guidance  by  the  Medical  Device  Coordination  Group  (MDCG)  and  by  notified 
bodies;  (ii)  webinars  and  training  by  notified  bodies;  (iii)  structured  dialogue  with 
notified  bodies17;  or  (iv)  EU-funded  work  to  make  notified  body  capacity  more 
visible18.  Additional  transition  time  is  necessary  to  allow  manufacturers  to  make 
greater use of these tools and therefore support the transition of their devices to the 
IVDR.  

This proposal aims to mitigate the risk of shortages of IVDs by giving manufacturers 
and  notified  bodies  more  time,  under  certain  conditions,  to  complete  the  necessary 
conformity assessment procedures, without lowering the requirements. 

The  need  for  additional  time  is  most  acute  for  mitigating  shortages  of  class  D 
devices. They constitute about 4% of the market16 but their conformity assessment is 
intensive due to  the requirement for individual technical  documentation  assessment 
and,  where  relevant,  involvement  of  the  scientific  bodies  (expert  panel  and  EU 
reference  laboratories).  With  only  12  notified  bodies  currently  designated,  capacity 
in the system to perform the required third party assessments remains limited, so an 
extension of the transitional period for class D IVDs should be combined with a shift 
in the transition deadlines for the other device groups as well to avoid a bottleneck in 
the certification process  and to  prevent  shortages of these devices too.  Class C and 
class  B  are  large  device  groups  (representing  26%  and  49%  of  the  market, 
respectively),  and  some  of  them  are  also  subject  to  special  requirements  such  as 
individual technical documentation assessment. It is also logical from the perspective 
of protection of public health that higher risk classes should be subject to the more 
stringent rules earlier than lower risk classes. 

The extension should be subject to conditions to support the transition to the IVDR, 
similar  to  the  approach  adopted  in  Regulation  (EU)  2023/607,  which  extended  the 
MDR  transitional period. These conditions  will ensure that only  manufacturers  that 
are actively taking the necessary steps to transition to the new rules and continue to 
place  on  the  market  devices  meeting  high  safety  standards  will  benefit  from  the 
additional time. In addition, at the latest by 26 May 2025, all manufacturers will have 

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https://www.medtecheurope.org/wp-content/uploads/2023/10/the-european-medical-technology-
industry-in-figures_2023-1.pdf.  
See action 15 in MDCG position paper MDCG 2022-14, Transition to the MDR and IVDR – Notified 
body capacity and availability of medical devices and IVDs (August 2022). 
https://nobocap.eu/  

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to put in place a quality management system in accordance with Article 10(8) IVDR. 
Such an approach respects the work of those manufacturers that have already taken 
the necessary steps to comply with the IVDR.  

Finally,  it  is  clear  that  an  extension  of  the  transitional  period  will  provide  only  a 
short-term  solution  to  mitigate  the  risk  of  shortages.  It  will  not  solve  certain 
underlying  structural  problems  related  to  the  implementation  of  the  IVDR,  notably 
with  regard  to  the  specific  situation  of  SMEs.  Moreover,  the  transition  must  be 
completed  to  ensure  the  credibility  and  robustness  of  the  EU  medical  device 
regulatory system and to provide the necessary legal certainty for a stable, innovative 
and  safe  environment.  It  is  necessary  to  analyse  problems  related  to  the 
implementation  of  the  IVDR  and  the  MDR,  and  their  root  causes,  to  identify 
shortcomings  of  the  regulatory  framework  and  remedy  them  in  the  medium  term 
with a view to ensuring patient safety and access to safe and performant devices in a 
sustainable manner. 

b)  European database on medical devices (Eudamed) 

In accordance with Article 33 MDR and Article 30 IVDR, the Commission must set 
up,  maintain  and  manage  the  European  database  on  medical  devices  (Eudamed). 
Eudamed must include seven electronic systems including  the UDI database19. It  is 
being  developed  in  accordance  with  functional  specifications  drawn  up  by  the 
Commission in collaboration with the MDCG and endorsed by the MDCG. Pursuant 
to  these  specifications,  Eudamed  will  consist  of  six  modules20,  covering  all  the 
the  Regulations:  UDI/Devices,  Actors,  Notified 
features 
bodies/Certificates,  Post-Market  Surveillance  and  Vigilance,  Market  Surveillance, 
and Clinical investigations/Performance studies. 

specified  by 

to  be 

completed 

Three Eudamed modules have been available for voluntary use since December 2020 
(Actors) and October 2021 (UDI/Devices; Notified bodies/Certificates). Two further 
modules  (Market  Surveillance;  Post-Market  Surveillance  and  Vigilance)  are 
expected 
(Clinical 
investigations/Performance studies) will not be completed before Q3/2026. Pursuant 
to the current MDR rules, Eudamed can only be used mandatorily from a certain date 
after the Commission has verified that Eudamed is fully functional and has published 
a notice to that effect. Therefore, the delayed development of the last module holds 
back the mandatory use of the electronic systems that have been completed already. 
The mandatory use of all six modules thus cannot be expected before Q4/2027, with 
additional transitional periods not ending before Q2/2029.  

in  Q2/2024.  The 

last  module 

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UDI stands for unique device identification. The UDI system and the UDI database are being set up in 
accordance with Articles 27 and 28 MDR.    
The  electronic  systems  for  registration  of  devices  and  for  the  UDI  database  are  merged  into  one 
UDI/Devices module to increase efficiency. As a consequence, Eudamed is composed of six modules. 

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However, the use of Eudamed is key for effective and efficient implementation of the 
MDR and IVDR and of high value to the work of the competent authorities and the 
Commission  in  monitoring  the  market.  Moreover,  the  deployment  of  Eudamed  has 
profound and beneficial implications in terms of resource savings for manufacturers 
as it prevents multiple registrations or instances of communication of data at national 
level. This proposal aims to enable a gradual implementation of individual Eudamed 
modules  once  they  have  been  audited  and  declared  functional.  Mandatory  use  of 
several modules could then start as early as Q4/2025. Consequently, also the specific 
transitional  provisions  in  the  MDR  and  IVDR  related  to  Eudamed  need  to  be 
amended  to  enable  a  smooth  progressive  transfer  from  multiple  registrations  in 
national databases to a single registration in Eudamed. 

In addition, having regard to the delay in the development of the module for clinical 
investigations  /  performance  studies,  the  timelines  for  the  application  of  the 
coordinated assessment of clinical investigations and performance studies need to be 
adapted.  Keeping  the  approach  provided  for  in  the  MDR  and  the  IVDR,  the 
coordinated  assessment  should  first  be  applied  by  Member  States  on  an  ‘opt-in’ 
basis.  Five  years  after  its  voluntary  application,  the  coordinated  assessment  should 
become mandatory for all Member States.  

c) 

Prior  notice  if  supply  of  certain  medical  devices  and  in  vitro  diagnostic 
medical devices is stopped  

Healthcare  professionals,  industry  and  competent  authorities  have  reported  that 
during the transitional period of the MDR and the IVDR, the supply of many medical 
devices and IVDs has or is likely to be stopped. In certain cases, especially if no or 
few alternative devices are available, the interruption of supply can result in serious 
harm or a risk of serious harm to patients or public health.  

This proposal aims to impose an obligation on manufacturers to inform their relevant 
competent  authority  and  health  institutions  before  they  cease,  temporarily  or 
permanently, the supply of a critical device. If manufacturers do not supply directly 
to  health  institutions  or  healthcare  professionals,  they  should  inform  the  relevant 
economic  operators  in  the  supply  chain,  which  then  can  inform  the  health 

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institutions.  This  mechanism  will  enable  the  authority  and  health  institutions  to 
consider mitigating measures to ensure patient health and safety. In accordance with 
Article 105 MDR, the MDCG may decide to provide guidance with the aim to ensure 
effective and harmonised implementation of this prior notice mechanism.  

• 

Consistency with existing policy provisions in the policy area 

The  proposal  is  consistent  with  existing  policy  provisions  as  well  as  ongoing 
non-legislative measures, which will supplement the proposed amendment. To avert 
the  risk  of  shortages  of  medical  devices,  the  European  Parliament  and  the  Council 
adopted in March 2023 Regulation (EU) 2023/60721 extending the MDR transitional 
period until 31 December 2027 or 31 December 2028, depending on the device’s risk 
class and subject to certain conditions. On 25 August 2022, the MDCG endorsed its 
position  paper  MDCG  2022-1422.  The  paper  sets  out  19  non-legislative  measures 
with  a  view  to  increasing  notified  body  capacity,  access  to  notified  bodies,  and 
manufacturers’ preparedness. This should support a successful transition to the MDR 
and  IVDR.  Several  of  the  measures  listed  in  MDCG  2022-14  have  already  been 
implemented,  such  as  a  MDCG  position  paper  on  hybrid  audits23,  new  MDCG 
guidance on appropriate  surveillance24, and a revision  of  MDCG 2019-6, removing 
obstacles to the employment of qualified personnel by notified bodies25. 

On 1 December 2022, the Commission adopted two delegated acts deferring the first 
complete  reassessment  of  notified  bodies26.  This  has  freed  up  capacity  of  both 
designating authorities and notified bodies.  

Work is ongoing to implement the remaining measures listed in MDCG 2022-14, as 
they  remain  important  also  under  an  extended  transitional  period.  Measures  to 
support  the  implementation  of  the  two  Regulations  are  regularly  (co-)funded  under 
annual work programmes of the EU4Health Programme27. Among other measures, in 

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Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending 
Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical 
devices and in vitro diagnostic medical devices (OJ L 80, 20.3.2023, p. 24). 
MDCG position paper MDCG 2022-14, Transition to the MDR and IVDR – Notified body capacity and 
availability of medical devices and IVDs (August 2022). 
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  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 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)  2023/502  of  1  December  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  (OJ  L  70,  8.3.2023,  p.  1);  Commission  Delegated  Regulation  (EU) 
2023/503 of 1 December 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 (OJ L 70, 8.3.2023, 
p. 3). 
E.g. under the 2022 EU4Health work programme: a call for proposals aiming to foster capacity building 
of  existing  and  new  notified  bodies,  to  facilitate  access  of  SMEs  and  first-time  applicants  to  notified 
bodies,  and  to  increase  preparedness  of  manufacturers  (see  HS-g-22-19.03);  various  measures 
supporting the implementation of the MDR and the IVDR (see HS-p-22-19.04, 06, 07, 08, 09, 10 and 
11);  and  direct  grants  for  Member  State  authorities:  strengthened  market  surveillance  of  medical 
devices  and  in  vitro  diagnostic  medical  devices  (HS-g-22-19.01).  Under  the  2023  EU4Health  work 
programme: support to the technical secretariat of the Notified Bodies Coordination Group (see HS-p-

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April  2023,  the  Commission  has  ordered  a  study  on  regulatory  governance  and 
innovation, which should provide preliminary results in Q3/2024.  

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

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

• 

Subsidiarity (for non-exclusive competence)  

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.  As 
regards  the  current  proposal  for  an  amendment,  EU  action  is  required  to:  (i)  avoid 
any potential disruption  in  the supply of  IVDs;  (ii) enable timely use of  completed 
Eudamed  modules;  (iii)  ensure  the  smooth  functioning  of  the  single  market;  and 
(iv) ensure a high level of health protection for patients and users. 

• 

Proportionality 

The proposed EU action is necessary to mitigate the risk of shortages of IVDs across 
the  EU  and  the  serious  impact  of  such  shortages  on  public  health.  The  proposed 
targeted amendments thus aim to help achieve the intended purpose of the MDR and 
the  IVDR.  This  purpose  is  to  set  a  robust,  transparent,  predictable  and  sustainable 
regulatory framework for medical devices and IVDs that guarantees a high level of 
protection  of  public  health  and  patient  safety  and  the  smooth  functioning  of  the 
single market for these products.  

The proposal maintains the objective of the IVDR to ensure a high level of safety and 
performance of devices by strengthening their scrutiny by notified bodies. It provides 
the  additional  time  needed  to  build the  necessary  capacity  and  expertise  to  achieve 
this  objective,  while  safeguarding  a  high  level  of  protection  of  public  health  and 
patient safety.  

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  IVDs  may  disappear  from  the  market. 
Therefore, the proposed amendments to the IVDR are limited to enabling a gradual 
implementation  of  the  requirements,  limited  to  ‘legacy’  devices28  that  require 
notified  body  involvement  in  the  conformity  assessment,  without  changing  the 
substance of these requirements. In addition, the extension of the transitional period 
is  subject  to  conditions  that  set  milestones  for  manufacturers  and  help  them  and 
notified  bodies  structure  the  transition.  The  Commission  proposes  to  differentiate 
between  higher-risk  devices  (i.e.  class  D)  and  medium-  to  lower-risk  devices  (i.e. 

28 

23-63);  and  call  for  proposals  for  a  programme  on  orphan  medical  devices,  in  particular  targeting 
paediatric patients (see HS-g-23-65). Under the 2024 EU4Health work programme: support to Eudamed 
(see HS-p-24-62); and studies supporting the evaluation of the MDR and the IVDR (HS-p-24-65). 
The term ‘legacy’ devices refers to devices placed on the market after the IVDR’s date of application in 
accordance with its transitional provisions in Article 110. For further explanations see  MDCG 2022-8, 
Regulation  (EU)  2017/746  -  application  of  IVDR  requirements  to  ‘legacy  devices’  and  to  devices 
placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC (May 2022).  

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class C, class B and class A sterile), with shorter transitional periods for higher-risk 
devices  and  longer  periods  for  lower-risk  ones.  This  approach  aims  to  balance  the 
available  notified  body  capacity  and  manufacturers’  level  of  preparedness  with  a 
high level of public health protection. 

As regards Eudamed, the proposal  is  proportionate as it enables faster achievement 
of the objective to increase transparency of the regulatory system. 

• 

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. 

3. 

• 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

Ex post evaluations / fitness checks of existing legislation 

Given the urgent nature of this proposal and the limited changes related only to the 
gradual roll-out of Eudamed and the extension of the IVDR transitional period, 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  primarily  aims  to  amend  the  transitional 
provisions,  giving,  under  certain  conditions,  additional  time  to  transition  to  the 
IVDR’s  requirements  to  avoid  shortages  and  protect  public  health  in  the  EU.  By 
enabling  an  earlier  mandatory  use  of  available  Eudamed  modules,  sometimes 
multiple  national  registrations  or  notifications  will  be  replaced  by  a  single 
registration/notification at EU level. The proposal will also increase transparency and 
traceability of medical devices and IVDs, facilitating monitoring of their availability 
and their safe performance by national competent authorities via EU-wide electronic 
means. The need to act  quickly to ensure certainty ahead of the end of the IVDR’s 
current  transitional  period  made  it  impossible  to  carry  out  a  broad  public 
consultation. Therefore, the Commission collected the necessary input from Member 
States and stakeholders through targeted exchanges. 

Input  from  Member  State  authorities  and  stakeholders  has  been  sought  through 
targeted interaction, mainly during the MDCG meetings on 10-11 October and 11-12 
and  18 December 2023  and  related  discussions 
in  MDCG  subgroups.  An 
extraordinary  MDCG  meeting  with  stakeholders  was  held  on  20 December 2023  to 
discuss issues related to possible amendments. An exchange of views with Member 
States took place on 30 November 2023 during the EPSCO Health Council. 

The Commission will continue to closely monitor the progress in the implementation 
of the Regulations and the impact of the proposed amendments. It will also consult 
with the MDCG and stakeholders about the need for supplementary action. 

In  accordance  with  Article  121  MDR  and  Article  111  IVDR,  the  Commission  is 
required to assess the application of the Regulations and produce an evaluation report 
at the latest by 27 May 2027. Having regard to the multiple challenges related to the 
implementation of the two Regulations, the Commission will start preparatory works 
for  a  targeted  evaluation  already  in  2024.  The  targeted  evaluation  will  assess  in 
particular whether the legislation has delivered results as intended, and whether it is 
(still) fit for purpose or underperforming in ensuring availability of devices for small 

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9 

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patient  populations  (i.e.  ‘orphan  devices’)  and  fostering  the  development  and 
availability of innovative devices in the EU. The implementation of the prior notice 
mechanism  for  monitoring  device  shortages  will  deserve  special  attention  in  the 
assessment,  as  well  as  costs  and  administrative  burdens  stemming  from  the 
implementation of the legislation, especially for SMEs.  

4. 

BUDGETARY IMPLICATIONS 

The proposed action has no budgetary implications 

5. 

• 

OTHER ELEMENTS 

Detailed explanation of the specific provisions of the proposal 

Article 1: amendments to the MDR  

Article 1 introduces a new Article 10a laying down an obligation on manufacturers to 
give  prior  notice  about  interruption  of  supply  of  certain  critical  medical  devices. 
Besides notification to the relevant competent authorities, manufacturers should also 
inform  health  institutions  or  healthcare  professionals  and  economic  operators  to 
whom  the  directly  supply  the  device.  The  relevant  economic  operators  should 
provide  the  information  in  the  downstream  supply  chain  until  it  reaches  the  health 
institutions or healthcare professionals. This mechanism will enable the authority and 
health  institutions  to  consider  mitigating  measures  to  ensure  patient  health  and 
safety. 

It also amends several provisions related to Eudamed. The changes to Article 34(1) 
and  (2)  remove  the  concept  that  the  use  of  Eudamed  can  only  become  mandatory 
when all its modules have been declared  fully functional. Instead, the new wording 
of  the  provisions  enable  a  gradual  implementation  of  individual  Eudamed  modules 
once they have been audited and declared functional.  

As the application of the coordinated assessment of clinical investigations depend on 
the  functionality  of  the  Eudamed  module  on  clinical  investigations  /  performance 
studies,  the  timeline  for  the  application  of  the  coordinated  assessment  has  been 
adapted  in  Article  78(14).  The  approach  is  kept  that  the  coordinated  assessment 
procedure should, during the first five years, apply only to Member States on an ‘opt-
in’ basis, before it will become mandatory for all Member States.  

Consequently, also the specific transitional provisions in Article 120(8), Article 122 
and Article 123(3) related to Eudamed are amended to enable a smooth progressive 
transfer  from  multiple  registrations  in  national  databases  to  a  single  registration  in 
Eudamed.  The  amendments  make  sure  that  national  registration  requirements  end 
when the registration requirements in Eudamed start to apply. Moreover, the changes 
clarify  which  devices  and  which  certificates  must  be  registered  in  Eudamed  and  in 
which timeframe.  

Article 2: amendments to the IVDR 

Article 2 contains the amendments to the IVDR, which mirror to a large extend the 
changes made to the MDR. A new Article 10a provides for a prior notice mechanism 
when a manufacturer anticipates the interruption of supply of certain critical in vitro 
diagnostic medical devices. The provisions concerning the timing of the application 
of  the  coordinated  assessment  of  performance  studies  (Article  74(14))  and  the 

EN 

10 

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specific transitional provisions related to Eudamed in Article 110(8), Article 112 and 
Article 113(3) are amended in a similar way as it is done in the MDR. 

In  addition,  Article  110(2)  and  (3)  are  amended  to  extend  the  IVDR’s  transitional 
periods.  For  that  purpose,  the  changes  in  Article  110(2)  extend  the  validity  of 
certificates  issued  under  Directives  98/79/EC  that  were  valid  on  the  day  of  the 
IVDR’s  date  of  application  (26  May  2022)  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  transitional 
period laid down in the proposed Article 110(3) to (3b). As regards certificates that 
have already expired when the proposed amendment comes into force, the extension 
will be subject to the condition that, at the moment of the expiry, the manufacturer 
has  signed  a  contract  with  a  notified  body  for  the  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 54 or have required the manufacturer to carry out the conformity assessment 
procedure within a specific time period in accordance with Article 92. 

The  changes  to  Article  110(3)  extend  the  transitional  periods  that  are  applicable  to 
‘legacy  devices’,  i.e.  those  covered  by  a  certificate  or  declaration  of  conformity 
issued  under  Directive  98/79/EC  before  26  May  2022.  Due  to  the  length  of  the 
provision,  paragraph  3  is  replaced  by  paragraphs  3  to  3e.  The  staggering  of  the 
transition  periods is  kept,  extending  the timeline  until  31 December 2027 for  IVDs 
covered by  a certificate  that was issued in  accordance with  Directive 98/79/EC and 
for  class  D  devices,  until  31  December  2028  for  class  C  devices  and  until  31 
December 2029 for class B and A sterile devices.  

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

○ 

○ 

○ 

the devices must continue to comply with Directive  98/79/EC. This condition 
is already part of the current Article 110(3);  

the  devices  do  not  undergo  significant  changes  in  the  design  and  intended 
purpose. This condition is already part of the current Article 110(3);  

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 89 and 90 of the IVDR. No systematic check of the device’s safety is 
required,  as  devices  covered  by  a  certificate  issued  under  Directive  98/79/EC 
will be under ‘appropriate surveillance’ by the body that issued the certificate 
or a notified body designated under the  IVDR. 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  2025,  the  manufacturer  has  put  in  place  a  quality 
management  system  (QMS)  in  accordance  with  Article  10(8)  of  the  IVDR. 
This condition aims to ensure that manufacturers gradually move towards full 
compliance  with  the  IVDR  requirements.  No  specific  attestation,  i.e.  no  self-

EN 

11 

  EN 

○ 

declaration  nor  verification  of  the  appropriateness  of  the  QMS  by  a  notified 
body, is required at this stage; 

by a specific date (26 May 2025, 26 May 2026 or 26 May 2027, depending on 
the risk class), the manufacturer, or its authorised representative, has lodged a 
formal application in accordance with Annex VII, Section 4.3, of the IVDR for 
conformity  assessment  in  respect  of  the  ‘legacy  device’  covered  by  a 
Directive’s  certificate  or  declaration  of  conformity,  or  in  respect  of  a  device 
intended to substitute that device under the IVDR. Within four months, such an 
application must be covered by a written agreement between the notified body 
and the manufacturer. This condition aims to ensure that only devices that the 
manufacturer intends to transition to the IVDR 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  the  relevant  deadline  set  in  Article 
110(3c). 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 Directive 98/79/EC 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 
IVDR  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 IVDR needs to be signed, that notified 
body would by default become responsible for the appropriate surveillance. 

Article 3: entry into force 

Article  3  provides  for  the  entry  into  force  of  the  Regulation  on  the  date  of  its 
publication and a deferred application of the prior notice mechanism.   

EN 

12 

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2024/0021 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of 
Eudamed, information obligation in case of interruption of supply and the transitional 
provisions for certain 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, 
Having regard to the opinion of the European Economic and Social Committee1,  
Having regard to the opinion of the Committee of the Regions2, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

1 
2 
3 

4 

5 

6 

Regulations  (EU) 2017/7453 and  (EU) 2017/7464 of  the  European  Parliament  and  of 
the Council establish a 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  set  out  in 
Council  Directives 90/385/EEC5 and 93/42/EEC6 and  Directive 98/79/EC  of 
the 

OJ C , , p. . 
OJ C , , p. . 
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, 
ELI: http://data.europa.eu/eli/reg/2017/745/oj). 
Regulation  (EU) 2017/746  of  the  European  Parliament  and  of  the  Council  of  5 April  2017  on in 
vitro diagnostic  medical 
and  Commission 
Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176, ELI: http://data.europa.eu/eli/reg/2017/746/oj). 
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States 
relating 
(OJ  L  189,  20.7.1990,  p.  17,  ELI: 
http://data.europa.eu/eli/dir/1990/385/oj).  
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1, 
ELI: http://data.europa.eu/eli/dir/1993/42/oj).  

implantable  medical  devices 

repealing  Directive 98/79/EC 

to  active 

devices 

and 

EN 

13 

  EN 

 
European Parliament and of the Council7, such as the supervision of notified bodies, 
risk classification, conformity assessment procedures, clinical evidence requirements, 
vigilance and market surveillance, and require the setting up of the European database 
on medical devices (‘Eudamed’) to enable transparency and traceability in respect of 
medical devices and in vitro diagnostic medical devices. 

Regulations  (EU) 2017/745 and  (EU) 2017/746  require  the  Commission  to  set  up, 
maintain  and  manage  Eudamed,  which  includes  seven  interconnected  electronic 
systems.  The  development  of  four  electronic  systems  has  been  completed  and  the 
completion  of  two  further  electronic  systems  is  expected  in  2024.  However,  the 
development  of  the  electronic  system  on  clinical  investigations  and  performance 
studies  is  significantly  delayed,  due  to  the  technical  complexity  of  requirements  and 
workflows to be implemented.  

Pursuant  to  Regulations  (EU) 2017/745  and  (EU) 2017/746,  the  obligations  and 
requirements  that  relate  to  Eudamed  are  to  apply  from  a  certain  date  after  the 
Commission has verified the full functionality of Eudamed and published a notice  to 
that effect. The delayed development of the last electronic system therefore holds back 
the mandatory use of the electronic systems that are available.  

The use of the electronic systems that are completed or that are about to be completed 
would  largely  support  the  effective  and  efficient  implementation  of  Regulations 
(EU) 2017/745 and (EU) 2017/746, decreasing the administrative burden for economic 
operators. A gradual roll-out of the individual electronic systems of Eudamed should 
therefore be allowed once their functionality has been verified in accordance with the 
procedure laid down in Regulation (EU) 2017/745. 

Having  regard  to  the  gradual  roll-out  of  Eudamed’s  electronic  systems  and  to  avoid 
overlapping periods of registration in national databases and in Eudamed, the dates of 
application of the obligations and requirements that relate to Eudamed and the dates of 
application  of  the  corresponding  national  registration  requirements  based  on 
Directives 90/385/EEC, 93/42/EEC and 98/79/EC should be aligned.  

Due to the delay of the development of the electronic system on clinical investigations 
and performance studies, the timeline for the application of the coordinated assessment 
for clinical investigations and performance studies should also be adapted, keeping the 
approach  that  Member  States  should  first  have  the  possibility  to  opt-in  before 
participation in the coordinated assessment becomes mandatory for all Member States.  

Despite  the  increase  in  the  number  of  notified  bodies  designated  in  accordance  with 
Regulation (EU) 2017/746, the overall capacity of notified bodies is still not sufficient 
to  ensure  the  certification  of  the  large  number  of  devices  which  are  to  undergo 
conformity assessment involving a notified body under that Regulation.  

The  number  of  applications  for  conformity  assessment  submitted  by  manufacturers 
and the number of certificates issued by notified bodies to date show that transition to 
the  Regulation  (EU) 2017/746  has  not  progressed  in  a  way  to  ensure  a  smooth 
transition to the new rules.  

It is very likely that many safe and critical in vitro diagnostic medical devices, which 
are essential for medical diagnosis and treatment of patients would not be certified in 

Directive 98/79/EC  of  the  European  Parliament  and  of  the  Council  of  27 October  1998  on in 
ELI: 
devices 
vitro diagnostic 
http://data.europa.eu/eli/dir/1998/79/oj).  

7.12.1998, 

medical 

331, 

(OJ 

1, 

p. 

L 

(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

7 

EN 

14 

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(10) 

accordance with Regulation (EU) 2017/746 before the end of the transitional periods. 
This leads to a risk of shortages especially of highest-risk (class D) devices by the end 
of the current transitional period on 26 May 2025. It is therefore necessary to ensure 
that there is an uninterrupted market supply of  in vitro diagnostic medical devices in 
the Union. 

In order to ensure a high level of protection of public health and patient safety, while 
safeguarding the smooth functioning of the internal market, as well as to provide legal 
certainty  and  avoid  potential  market  disruption,  it  is  therefore  necessary  to  extend 
further  the  transitional  periods  laid  down  in  Regulation  (EU)  2017/746  for  devices 
covered  by  certificates  issued  by  notified  bodies  in  accordance  with  Directive 
98/79/EC  and  for  devices  which  are  to  undergo  conformity  assessment  involving  a 
notified  body  for  the  first  time  under  Regulation  (EU)  2017/746.  To  achieve  those 
objectives, the extended transitional period should concern all device classes so as to 
guarantee  a  manageable  distribution  of  workload  on  notified  bodies  across  time  and 
avoid any impediment to the certification process.  

(11)  The  extension  should  be  of  sufficient  duration  to  give  manufacturers  and  notified 
bodies  the  time  necessary  to  carry  out  the  required  conformity  assessments.  The 
extension  should  aim  to  ensure  a  high  level  of  public  health  protection,  including 
patient  safety  and  an  avoidance  of  shortages  of  in  vitro diagnostic  medical  devices 
needed  for  the  smooth  functioning  of  healthcare  services,  without  lowering  current 
quality or safety requirements.  

(12)  The extension should be subject to certain conditions to ensure that only devices that 
are safe and for which the manufacturers have taken certain steps to transition towards 
compliance with Regulation (EU) 2017/746 are to benefit from the additional period. 

(13)  To  ensure  a  progressive  transition  to  Regulation  (EU) 2017/746,  the  appropriate 
surveillance  regarding  devices  benefiting  from  the  transitional  period  should  be 
transferred  from  the  notified  body  that  issued  the  certificate  in  accordance  with 
Directive 98/79/EC  to  a  notified  body  designated  under  Regulation  (EU) 2017/746. 
For  reasons  of  legal  certainty,  the  notified  body  designated  under  Regulation 
(EU) 2017/746 should not be responsible for conformity assessment and surveillance 
activities carried out by the notified body that issued the certificate. 

(14)  As regards the periods needed to allow manufacturers and notified bodies to carry out 
the  conformity  assessment  in  accordance  with  Regulation  (EU) 2017/746  of  in  vitro 
diagnostic  medical  devices  that  are  covered  by  a  certificate  or  a  declaration  of 
conformity  that  was  issued  in  accordance  with  Directive 98/79/EC,  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 
transitional 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. 

(15)  Having  regard  to  the  impact  that  shortages  of  certain  medical  devices  may  have  on 
patient  safety  and  public  health,  a  prior  notice  mechanism  should  be  introduced  to 
enable  in  particular  competent  authorities  and  health  institutions  to  take  mitigating 
measures  where  necessary  to  ensure  patient  health  and  safety.  Therefore,  where 
manufacturers for any reason anticipate the interruption of supply of medical devices 
or  in  vitro diagnostic  medical  devices  and  it  is  reasonably  foreseeable  that  the 
interruption may result in serious harm or a risk of serious harm to patients or public 
health  in  one  or  more  Member  States,  the  manufacturer  should  notify  the  relevant 

EN 

15 

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competent authorities as well as the economic operators to whom they directly supply 
the device and, where applicable, the health institutions or healthcare professionals to 
whom they directly supply the device, thereof. The risk of serious harm to patients or 
public  health  may,  for  example,  be  due  to  the  relevance  of  the  device  for  ensuring 
essential healthcare services in one or more Member States, the dependency of patient 
health and safety on the continuous availability of the device in one or more Member 
States, or the absence of suitable alternatives, also considering the expected length of 
the supply interruption, the quantities of devices already made available on the market 
and  available  stocks  or  timelines  for  procuring  alternative  devices.  The  information 
should  be  provided  by  the  manufacturer  and  other  economic  operators  in  the 
downstream supply chain until it reaches the relevant health institutions or healthcare 
professionals.  As  the  risk  of  shortages  is  particularly  relevant  during  the  transition 
from Directives 90/385/EEC, 93/42/EEC and 98/79/EC to Regulations (EU) 2017/745 
and (EU) 2017/746, the prior notice mechanism should also apply to devices placed on 
the market in accordance with the transitional provisions laid down in Article 120 of 
Regulation (EU) 2017/745 and Article 110 of Regulation (EU) 2017/746. 

(16)  Regulations  (EU) 2017/745  and  (EU) 2017/746  should 

therefore  be  amended 

accordingly. 

(17)  Since the objectives of this Regulation, namely to address risks of shortages of in vitro 
diagnostic medical devices in the Union and the timely roll-out of Eudamed, cannot be 
sufficiently achieved by the Member States but can rather, by reason of their 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 (‘TEU’). 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. This Regulation is being adopted in view of the exceptional 
circumstances  arising  from  an  imminent  risk  of  shortages  of  in  vitro  diagnostic 
medical  devices  and  the  associated  risk  of  a  public  health  crisis,  as  well  as  the 
significant delay in the development of the last electronic system of Eudamed. In order 
intended  effect  of  amending  Regulations  (EU) 2017/745  and 
to  attain 
(EU) 2017/746  and  to  ensure  availability  of  devices  whose  certificates  have  already 
expired  or  are  due  to  expire  before  26 May  2025,  to  provide  legal  certainty  for 
economic operators and healthcare providers, and for reasons of consistency as regards 
the  amendments  to  both  Regulations,  this  Regulation  should  enter  into  force  as  a 
matter  of  urgency.  For  the  same  reasons,  it  is  also  considered  to  be  appropriate  to 
invoke  the  exception  to  the  eight-week  period  provided  for  in  Article 4  of  Protocol 
No 1 on the role of national Parliaments in the European Union, annexed to the TEU, 
to the Treaty on the Functioning of the European Union and to the Treaty establishing 
the European Atomic Energy Community. 

the 

(18)  To allow manufacturers and other economic operators time to adapt to the obligation 
to  provide  notice  of  an  anticipated  interruption  of  supply  of  certain  devices,  it  is 
appropriate to defer the application of the provisions related to such obligation, 

HAVE ADOPTED THIS REGULATION: 

Article 1 

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

Amendments to Regulation (EU) 2017/745 

EN 

16 

  EN 

(1) 

the following Article 10a is inserted: 

‘Article 10a 

Obligations in case of interruption of supply of certain devices  

1.  Where  a  manufacturer  anticipates  an  interruption  of  the  supply  of  a  device, 
other  than  a  custom-made  device,  and  where  it  is  reasonably  foreseeable  that 
this interruption may result in serious harm or a risk of serious harm to patients 
or public health in one or more Member States, the manufacturer  shall inform 
the  competent  authority  of  the  Member  State  where  it  or  its  authorised 
representative  is  established,  as  well  as  the  economic  operators,  health 
institutions  and  healthcare  professionals  to  whom  the  manufacturer  directly 
supplies the device, of the anticipated interruption. 

2. 

3. 

The  information  referred  to  in  the  first  subparagraph  shall,  other  than  in 
exceptional  circumstances,  be  provided  at  least  six  months  before  the 
anticipated  interruption.  The  information  provided  to  the  competent  authority 
shall specify the reasons for the interruption. 

The  competent  authority  that  has  received  the  information  referred  to  in 
paragraph 1 shall inform without undue delay the competent authorities of the 
other Member States and the Commission of the anticipated interruption. 

The  economic  operators  who  have  received  the  information  from  the 
manufacturer  in  accordance  with  paragraph  1,  shall  inform  without  undue 
delay  any  other  economic  operators,  health  institutions  and  healthcare 
professionals  to  whom  they  directly  supply  the  device  of  the  anticipated 
interruption.’  

(2) 

Article 34 is amended as follows: 

(a) 

in paragraph 1, the third sentence is deleted; 

(b)  paragraph 2 is replaced by the following: 

‘2.  The  Commission  shall  inform  the  MDCG  when,  on  the  basis  of 
independent  audit  reports,  it  has  verified  that  one  or  more  of  the 
electronic systems referred to in Article 33(2) are functional and meet the 
functional  specifications  drawn  up  pursuant  to  paragraph  1  of  this 
Article.’; 

(3) 

in Article 78, paragraph 14 is replaced by the following: 

‘14.  All  Member  States  shall  be  required  to  apply  the  procedure  set  out  in  this 
Article from the date corresponding to  five years after the date of publication 
of  the  notice  referred  to  in  Article  34(3)  informing  thatthe  electronic  system 
referred  to  in  Article  33(2),  point  (e),  is  functional  and  meets  the  functional 
specifications drawn up pursuant to Article 34(1). 

Before that date and at the earliest six months after the date of publication of 
the  notice  referred  to  in  the  first  subparagraph,  the  procedure  set  out  in  this 
Article  shall  be  applied  only  by  those  Member  States  in  which  the  clinical 
investigation is to be conducted which have agreed to apply it.’; 

(4) 

Article 120 is amended as follows: 

(a) 

paragraph 8 is deleted; 

(b) 

the following paragraph 13 is added: 

EN 

17 

  EN 

’13.  Article 10a shall apply also to devices referred to in paragraphs 3, 3a and 

3b of this Article.’; 

(5) 

in Article 122, first paragraph, the first, second, third and fourth indents are replaced 
by the following: 

‘-  Articles 8 and 10, Article 10b(1), points  (b) and (c),  Article 10b(2) and (3) of 
Directive 90/385/EEC  and  Article 10,  Article 14a(1),  points  (c)  and  (d), 
Article 14a(2)  and  (3)  and  Article 15  of  Directive 93/42/EEC,  and  the 
obligations relating to vigilance and clinical investigations provided for in the 
corresponding Annexes to those Directives, which are repealed, as applicable, 
with  effect  from  the  date  referred  to  in  Article 123(3),  point (d),  of  this 
Regulation  in  respect  of  the  application  of  the  obligations  and  requirements 
that relate to the electronic systems referred to in Article 33(2), points (e) and 
(f), respectively; 

- 

Article 10a,  Article 10b(1),  point (a),  and  Article 11(5)  of  Directive 
90/385/EEC  and  Article 14(1)  and  (2),  Article 14a(1),  points (a)  and  (b),  and 
Article 16(5)  of  Directive  93/42/EEC,  and 
to 
registration of devices and economic operators, and to certificate notifications, 
provided  for  in  the  corresponding  Annexes  to  those  Directives,  which  are 
repealed, as applicable, with effect from the date referred to in Article 123(3), 
point (d), of this Regulation in respect of the application of the obligations and 
requirements  that  relate  to  the  electronic  systems  referred  to  in  Article  33(2), 
points (a), (c) and (d), respectively;’;  

the  obligations  relating 

(6) 

Article 123(3) is amended as follows: 

(a) 

point (d) is amended as follows:  

(i) 

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

‘without  prejudice  to  the  obligations  of  the  Commission  pursuant  to 
Article  34,  the  obligations  and  requirements  that  relate  to  any  of  the 
electronic systems  referred to in  Article 33(2)  shall apply  from  the date 
corresponding  to  six  months  after  the  date  of  publication  of  the  notice 
referred to in Article 34(3) informing that the relevant electronic system 
is functional and meets the functional specifications drawn up pursuant to 
Article 34(1).’;  

(ii) 

after the twelfth indent, the following indent is inserted: 

‘- Article 56(5),’; 

(iii) 

the fourteenth indent is replaced by the following: 

‘- Article 78(1) to (13), without prejudice to Article 78(14),’; 

(iv) 

the second paragraph is replaced by the following: 

of 

‘Until  the  date  of  application  of  the  provisions  referred  to  in  the  first 
of 
provisions 
the 
this 
paragraph 
Directives 90/385/EEC  and  93/42/EEC 
information  on 
vigilance  reporting,  clinical  investigations,  registration  of  devices  and 
economic operators, and certificate notifications shall continue to apply.’; 

corresponding 
regarding 

point, 

(b)  point (e) is replaced by the following: 

EN 

18 

  EN 

‘(e)  no  later  than  6  months  after  the  date  referred  to  in  point  (d)  of  this 
paragraph, manufacturers shall ensure that the information to be entered 
in  Eudamed  in  accordance  with  Article 29  is  entered  in  the  electronic 
system referred to in Article 33(2), point (a), also regarding the following 
devices,  provided  that the same devices  are placed  on market also from 
the date referred to in point (d) of this paragraph: 

(i) 

(ii) 

devices,  other 
than  custom-made  devices,  for  which 
manufacturer  has  undertaken  a  conformity  assessment 
accordance with Article 52; 

the 
in 

devices,  other  than  custom-made  devices,  placed  on  the  market 
pursuant  to  Article  120(3),  (3a)  or  (3b),  unless  the  device,  for 
which the manufacturer has undertaken a conformity assessment 
in  accordance  with  Article  52, 
in 
Eudamed;’; 

is  already  registered 

(c) 

the following points are inserted after point (e): 

‘(ea)  no  later  than  12  months  after  the  date  referred  to  in  point  (d)  of  this 
paragraph, notified bodies shall ensure that the information to be entered 
in Eudamed in accordance with Article 56(5) is entered in the electronic 
system  referred  to  in  Article  33(2),  point  (d),  also  regarding  devices 
referred to in point (e), (i), of this paragraph. For those devices, only the 
latest  relevant  certificate  and,  if  applicable,  any  decision  taken  by  the 
notified body related to such certificate shall be entered;  

(eb)  by  way  of  derogation  from  the  first  paragraph  of  point  (d)  of  this 
paragraph,  the  obligations  to  upload  the  summary  of  safety  and  clinical 
performance  in  accordance  with  Article  32(1)  and  to  notify  competent 
authorities  in  accordance  with  Article  55(1),  through  the  electronic 
system referred in Article 33(2), point (d), shall apply to devices referred 
to  in  point  (e)  of  this  paragraph  when  the  certificate  is  entered  in 
Eudamed in accordance with point (ea) of this paragraph; 

(ec)  without  prejudice  to  the  first  paragraph  of  point  (d)  of  this  paragraph, 
when  a  manufacturer  has  to  submit  a  PSUR  in  accordance  with  Article 
86(2)  or  report  a  serious  incident,  a  field  safety  corrective  action  in 
accordance  with  Article  87  or  submit  a  trend  report  in  accordance  with 
Article  88  through  the  electronic  system  referred  to  in  Article  33(2), 
point (f), it shall also register the device, which is subject of the PSUR or 
the vigilance report, in the electronic system referred to in Article 33(2), 
point (a), except if such device was placed on the market in accordance 
with Directive 90/385/EEC or Directive 93/42/EEC;’; 

(d)  point (h) is deleted. 

Article 2 

Amendments to Regulation (EU) 2017/746  

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

(1) 

the following Article 10a is inserted: 

EN 

19 

  EN 

‘Article 10a 

Obligations in case of interruption of supply of certain devices  

1.  Where a manufacturer anticipates an interruption of the supply of a device and 
where  it  is  reasonably  foreseeable  that  this  interruption  may  result  in  serious 
harm  or  a  risk  of  serious  harm  to  patients  or  public  health  in  one  or  more 
Member  States,  the  manufacturer  shall  inform  the  competent  authority  of  the 
Member State where it or its authorised representative is established, as well as 
the  economic  operators,  health  institutions  and  healthcare  professionals  to 
whom it directly supplies the device, of the anticipated interruption.  

2. 

3. 

The  information  referred  to  in  the  first  subparagraph  shall,  other  than  in 
exceptional  circumstances,  be  provided  at  least  six  months  before  the 
anticipated  interruption.  The  information  provided  to  the  competent  authority 
shall specify the reasons for the interruption.  

The  competent  authority  that  has  received  the  information  referred  to  in 
paragraph 1 shall inform without undue delay the competent authorities of the 
other Member States and the Commission of the anticipated interruption.  

The  economic  operators  who  have  received  the  information  from  the 
manufacturer  in  accordance  with  paragraph  1,  shall  inform  without  undue 
delay  any  other  economic  operators,  health  institutions  and  healthcare 
professionals  to  whom  they  directly  supply  the  device  of  the  anticipated 
interruption.’  

(2) 

in Article 74, paragraph 14 is replaced by the following: 

‘14.  All  Member  States  shall  be  required  to  apply  the  procedure  set  out  in  this 
Article from the date corresponding to 5 years after the date of publication of 
the notice referred to in Article 34(3) of Regulation (EU) 2017/745 informing 
that  the  electronic  system  referred  to  in  Article  33(2),  point  (e),  of  that 
Regulation  is  functional  and  meets  the  functional  specifications  drawn  up 
pursuant to Article 34(1) of that Regulation. 

Before that date and at the earliest six months after the date of publication of 
the  notice  referred  to  in  the  first  subparagraph,  the  procedure  set  out  in  this 
Article shall be applied only by those Member States in which the performance 
study is to be conducted which have agreed to apply it.’; 

(3) 

Article 110 is amended as follows: 

(a) 

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

‘Certificates  issued  by  notified  bodies  in  accordance  with  Directive  98/79/EC 
from 25 May 2017 that were still valid on 26 May 2022 and that have not been 
withdrawn  afterwards  shall  remain  valid  after  the  end  of  the  period  indicated 
on  the  certificate  until  31  December  2027.  Certificates  issued  by  notified 
bodies in accordance with that Directive from 25 May 2017 that were still valid 
on  26 May  2022  and  that  have  expired  before  [OP:  please  insert  the  date  = 
date of entry into force of this amending Regulation] shall be considered to be 
valid  until  31  December  2027  only  if  one  of  the  following  conditions  is 
fulfilled: 

(a) 

before  the  date  of  expiry  of  the  certificate,  the  manufacturer  and  a 
notified  body  have  signed  a  written  agreement  in  accordance  with 

EN 

20 

  EN 

Section 4.3, second subparagraph of Annex VII to this Regulation 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; 

(b) 

a competent authority of a Member State has granted a derogation from 
the  applicable  conformity  assessment  procedure  in  accordance  with 
Article 54(1)  of  this  Regulation  or  has  required  the  manufacturer,  in 
accordance  with  Article 92(1)  of  this  Regulation,  to  carry  out  the 
applicable conformity assessment procedure.’; 

(b)  paragraph 3 is replaced by the following: 

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

(c) 

the following paragraphs 3a to 3e are inserted: 

‘3a.  Devices  which  have  a  certificate  that  was  issued  in  accordance  with 
Directive 98/79/EC  and  that  is  valid  by  virtue  of  paragraph  2  of  this 
Article  may  be  placed  on  the  market  or  put  into  service  until  31 
December 2027. 

3b.  Devices  for  which  the  conformity  assessment  procedure  pursuant  to 
Directive  98/79/EC  did  not  require  the  involvement  of  a  notified  body, 
for  which  a  declaration  of  conformity  was  drawn  up  prior  to  26 May 
2022  in  accordance  with  that  Directive,  and  for  which  the  conformity 
assessment  procedure  pursuant 
the 
to 
involvement of a notified body, may be placed on the market or put into 
service until the following dates: 

this  Regulation 

requires 

(a) 

31 December 2027, for class D devices; 

(b)  31 December 2028, for class C devices; 

(c) 

31  December  2029,  for  class  B  devices  and  for  class  A  devices 
placed on the market in sterile condition.  

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

(a) 

those devices continue to comply with Directive 98/79/EC; 

(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  2025,  the  manufacturer  has  put  in  place  a 
quality management system in accordance with Article 10(8); 

(e) 

the  manufacturer  or  the  authorised  representative  has  lodged  a 
formal application with a notified body in accordance with Section 
4.3, first subparagraph of Annex VII for conformity assessment in 
respect of a device referred to in paragraph 3a or 3b of this Article 

EN 

21 

  EN 

or in respect of a device intended to substitute that device, no later 
than: 

(i) 

26  May  2025,  for  devices  referred  to  in  paragraph  3a  and 
paragraph 3b, point (a); 

(ii)  26 May 2026, for devices  referred to  in  paragraph 3b, point 

(b); 

(iii)  26 May 2027, for devices  referred to  in  paragraph 3b, point 

(c); 

(f) 

the  notified  body  and  the  manufacturer  have  signed  a  written 
agreement in accordance with Section 4.3, second subparagraph of 
Annex VII no later than: 

(i) 

26  September 2025, for  devices referred to  in  paragraph 3b, 
point (a); 

(ii)  26  September 2026, for  devices referred to  in  paragraph 3b, 

point (b); 

(iii)  26  September 2027, for  devices referred to  in  paragraph 3b, 

point (c). 

3d.  By  way  of  derogation  from  paragraph  3,  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 the paragraphs 3a and 3b of this Article, instead 
of the corresponding requirements in Directive 98/79/EC. 

3e.  Without  prejudice  to  Chapter  IV  and  paragraph  1  of  this  Article,  the 
notified body that issued the certificate referred to in paragraph 3a 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 
latter  shall  carry  out  such 
surveillance. 

that 

the 

No  later  than  26  September  2025,  the  notified  body  that  has  signed  the 
written  agreement  referred  to  in  paragraph  3c,  point  (f),  shall  become 
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 98/79/EC, 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 38  shall  be  clearly  defined  in  an  agreement 
between the manufacturer and 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.’; 

(d)  paragraph 8 is deleted;  

EN 

22 

  EN 

(e) 

the following paragraph 11 is added: 

‘11.  Article 10a shall apply also to devices referred to in paragraphs 3, 3a and 

3b of this Article.’;  

(4) 

Article 112 is amended as follows:  

(a) 

the first paragraph is replaced by the following:  

‘Without  prejudice  to  Article 110(3)  to  (3e)  and (4),  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 Directive 98/79/EC, that Directive is repealed with effect 
from 26 May 2022, with the exception of: 

(a)  Article 11, Article 12(1), point (c), and Article 12(2) and (3) of Directive 
98/79/EC,  and  the  obligations  relating  to  vigilance  and  performance 
studies  provided  for  in  the  corresponding  Annexes  to  that  Directive, 
which are repealed, as applicable, with effect from the date referred to in 
Article 113(3), point (f), of this Regulation in respect of the application 
of the obligations  and  requirements  that  relate to the electronic systems 
referred to in, respectively, Article 33(2), points (e) and (f), of Regulation 
(EU) 2017/745; 

(b)  Article  10,  Article  12(1),  points  (a)  and  (b),  and  Article  15(5)  of 
Directive 98/79/EC, and the obligations relating to registration of devices 
and economic operators, and certificate notifications provided for in the 
corresponding  Annexes  to  that  Directive,  which  are  repealed,  as 
applicable,  with  effect  from  the  date  referred  to  in  Article 113(3), 
point (f),  of  this  Regulation  in  respect  of  the  application  of  the 
obligations and requirements that relate to the electronic systems referred 
to  in,  respectively,  Article  33(2),  points  (a),  (c)  and  (d),  of  Regulation 
(EU) 2017/745.’; 

(b) 

the second paragraph is replaced by the following: 

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

(5) 

Article 113(3) is amended as follows: 

(a) 

point (a) is deleted;  

(b)  point (f) is amended as follows:   

(i) 

the first paragraph is amended as follows: 

(1) 

the  first  sentence  of  the  introductory  wording  is  replaced  by  the 
following: 

‘without prejudice to the obligations of the Commission pursuant to 
Article  34  of  Regulation  (EU)  2027/745,  the  obligations  and 
requirements that relate to any of the electronic systems referred to 
in  Article  33(2)  of  that  Regulation  shall  apply  from  the  date 
corresponding  to  six  months  after  the  date  of  publication  of  the 
notices  referred  to  in  Article  34(3)  of  that  Regulation  informing 
that  the  relevant  electronic  system  is  functional  and  meets  the 

EN 

23 

  EN 

functional specifications drawn up pursuant to Article 34(1) of that 
Regulation.’; 

(2) 

after the tenth indent, the following indent is inserted: 

‘- Article 51(5),’; 

(3) 

the twelth indent is replaced by the following: 

‘- Article 74(1) to (13), without prejudice to Article 74(14),’; 

(4) 

the last indent is replaced by the following: 

‘- Article 110(3d).’; 

(ii) 

the second paragraph is replaced by the following: 

‘Until  the  date  of  application  of  the  provisions  referred  to  in  the  first 
paragraph  of  this  point,  the  corresponding  provisions  of  Directive 
98/79/EC  regarding  information  on  vigilance  reporting,  performance 
studies,  registration  of  devices  and  economic  operators,  and  certificate 
notifications shall continue to apply.’; 

(c) 

the following points are inserted after point (f): 

‘(fa)  no  later  than  6  months  after  the  date  referred  to  in  point  (f)  of  this 
paragraph, manufacturers shall ensure that the information to be entered 
in Eudamed in accordance with Article 26 is entered in the the electronic 
system  referred  to  in  Article  33(2),  point  (a),  of  Regulation  (EU) 
2027/745  also  regarding  the  following  devices  ,  provided  that  the  same 
devices are placed on market also from the date referred to in point (f) of 
this paragraph: 

(i) 

devices  for  which  the  manufacturer  has  undertaken  a  conformity 
assessment in accordance with Article 48; 

(ii)  devices  placed  on  the  market  pursuant  to  Article  110(3),  (3a)  or 
(3b), unless the device, for which the manufacturer has undertaken 
a conformity  assessment  in  accordance with  Article  48, is  already 
registered in Eudamed; 

(fb)  no  later  than  12  months  after  the  date  referred  to  in  point  (f)  of  this 
paragraph, notified bodies shall ensure that the information to be entered 
in  Eudamed  in  accordance  with  Article 51(5)  of  this  Regulation  is 
entered in the electronic system referred to in Article 33(2), point (d), of 
Regulation  (EU)  2027/745  also  regarding  devices  referred  to  in  point 
(fa),  (i),  of  this  paragraph.  For  those  devices,  only  the  latest  relevant 
certificate  and,  if  applicable,  any  decision  taken  by  the  notified  body 
related to such certificate shall be entered;  

(fc)  by  way  of  derogation  from  the  first  paragraph  of  point  (f)  of  this 
paragraph,  the  obligations  to  upload  the  summary  of  safety  and 
performance  in  accordance  with  Article  29(1)  of  this  Regulation  and  to 
notify  competent  authorities  in  accordance  with  Article  50(1)  of  this 
Regulation, through the electronic system referred in Article 33(2), point 
(d),  of  Regulation  (EU)  2017/745  shall  apply  to  devices  referred  to  in 
point (fa) of this paragraph when the certificate is entered in Eudamed in 
accordance with point (fb) of this paragraph; 

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(fd)  without  prejudice  to  the  first  paragraph  of  point  (f)  of  this  paragraph, 
when  a  manufacturer  has  to  submit  a  PSUR  in  accordance  with  Article 
81(2)  or  report  a  serious  incident,  a  field  safety  corrective  action  in 
accordance  with  Article  82  or  submit  a  trend  report  in  accordance  with 
Article  83  through  the  electronic  system  referred  to  in  Article  33(2), 
point (f), of Regulation  (EU) 2017/745,  it shall also  register the device, 
which  is  subject  of  the  PSUR  or  the  vigilance  report,  in  the  electronic 
system referred to in Article 33(2), point (a), of that Regulation, except if 
such  device  was  placed  on  the  market  in  accordance  with  Directive 
98/79/EC;’; 

(d)  point (g) is deleted; 

(e) 

in point (j), the date ‘26 May 2028’ is replaced by ‘31 December 2030’.  

Article 3 

Entry into force 

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

Article 1, point (1), and Article 2, point (1), shall apply from [OP: please insert the date = 6 
months after entry into force of this amending Regulation].  

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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