Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices
Date: 2021-10-14
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: coronavirus disease, epidemic, marketing standard, medical device, medical diagnosis, public health, quality standard, safety standard, single market

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   EUROPEAN COMMISSION  Brussels, 14.10.2021  COM(2021) 627 final 2021/0323 (COD)  Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices (Text with EEA relevance)  
 
1. 

• 

EXPLANATORY MEMORANDUM 

CONTEXT OF THE PROPOSAL 

Reasons for and objectives of the proposal 
Regulation  (EU)  2017/746  of  the  European  Parliament  and  of  the  Council1 
establishes a new regulatory framework for in vitro diagnostic medical devices, such 
as HIV tests, pregnancy tests or SARS-CoV-2 tests. It is estimated that around 70% 
of clinical decisions are made using in vitro diagnostic medical devices2. 

The new Regulation (EU) 2017/746 will replace the current Directive 98/79/EC on in 
vitro  diagnostic  medical  devices3  from  26 May 2022  and  introduce  substantial 
changes in the sector. The Regulation aims to ensure the smooth functioning of the 
internal  market  and  a  high  level  of  protection  of  public  health,  patients  and  users, 
taking into account the high number of small and medium-sized enterprises (SMEs)  
active in this sector. 

One  of  the  main  changes  concerns  the  involvement  of  independent  conformity 
assessment  bodies  (‘notified  bodies’).  Currently,  only  a  relatively  small  number  of 
high-risk  devices  (about  8%  of  all  in  vitro  diagnostics  on  the  market)  is  subject  to 
notified body control under Directive 98/79/EC4. Under the Regulation, around 80% 
of in vitro diagnostic medical devices will be under the control of notified bodies, the 
vast majority of them for the first time5. That means that manufacturers will need to 
apply to a notified body and obtain one or more certificates after completion of the 
appropriate  conformity  assessment  procedure,  before  being  able  to  place  their 
devices on the market. On average, a conformity assessment procedure takes around 
1  year,  after  which  additional  time  (around  6  months)  is  needed  to  produce  the 
devices  and  prepare  them  for  release  on  the  market,  according  to  information 
provided by the medical device industry6. 

Article 110 of Regulation (EU) 2017/746 contains transitional provisions for devices 
with  a  certificate  issued  by  a  notified  body  in  accordance  with  Directive  98/79/EC 
prior  to  26 May 2022.  Only  devices  that  require  a  notified  body  certificate  already 
under  Directive  98/79/EC  (around  8%)  will  benefit  from  these  transitional 

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. 

the 

2022  when 

2  MedTech Europe Survey Report analysing the availability of In vitro Diagnostic Medical Devices (IVDs) in 
May 
2021 
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/ 
(hereafter 
referred  to  as  Medtech  Europe  Survey  Report);  Rohr  U-P,  Binder  C,  Dieterle  T,  Giusti  F,  Messina  CGM, 
Toerien E, et al. (2016), The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PLoS 
ONE 11(3): e0149856. https://doi.org/10.1371/journal.pone.0149856 

Regulation 

September 

applies, 

IVD 

new 

EU 

8 

3  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. 

4  Those listed in Annex II to Directive 98/79/EC and devices for self-testing. 
5  MedTech Europe Survey Report (see footnote 2), p. 4. The impact assessment accompanying the Commission 
proposal for a Regulation on in vitro diagnostic medical devices, COM(2012)541 final, estimated that nearly 
90-95% of in vitro diagnostic medical devices would fall in classes B, C or D and would therefore be subject 
to notified body involvement, see SWD(2012)273 final, part III, Annex 2, Sections 4.4 and 4.5. 

6  Medtech Europe Survey Report (see footnote 2), p. 8. 

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provisions.  This  Commission  proposal  builds  on  those  existing  transitional 
provisions by extending their scope and timelines.  

The  COVID-19  pandemic  has,  on  the  one  hand,  confirmed  the  need  for  a  robust 
regulatory framework for in vitro diagnostic medical devices in the EU. For instance, 
it has illustrated how essential it is for tests placed on the EU market to be accurate, 
reliable and safe when detecting the presence of viruses such as SARS-CoV-2. 

On the other hand, the COVID-19 pandemic and the associated public health crisis 
have given rise to additional and unprecedented challenges for the implementation of 
Regulation  (EU)  2017/746.  These  extraordinary  circumstances  have  demanded 
substantial  additional  resources  from  Member  States’  competent  authorities,  health 
institutions, notified bodies, manufacturers and other economic operators to increase 
the availability of vitally important medical diagnostics. This was due not only to a 
shift  in  priorities,  new  tasks  and  a  significant  workload,  but  also  to  induced  travel 
restrictions and quarantine orders. 

the  proper 

implementation  and  application  of 

These  extraordinary  circumstances  have  had  a  significant  impact  on  various  areas 
covered  by  Regulation  (EU)  2017/746.  Data  on  market  readiness  collected  by  the 
European Commission during the first half of 20217 show that Member States, health 
institutions,  notified  bodies  and  economic  operators  will  not  be  in  a  position  to 
the  Regulation  from 
ensure 
26 May 2022. 
In particular, with only six notified bodies designated8 so far under Regulation (EU) 
2017/746, there is a grave shortage of notified body capacity, making it impossible 
for manufacturers to conduct the legally required conformity assessment procedures 
in  time.  As  the  currently  designated  notified  bodies  are  established  in  only  three 
countries  (Germany,  France  and  the  Netherlands),  the  situation  is  particularly 
problematic for SMEs established in other Member States, which have a tendency to 
apply  to  notified  bodies  in  their  own  or  neighbouring  Member  States.  In  addition, 
due  to  COVID-19  travel  restrictions,  notified  bodies  were  not  able  to  carry  out  the 
required  on-site  audits  at  the  manufacturers’  premises  to  verify  the  manufacturing 
and other relevant processes9. Travel restrictions are still in place in various regions 
of the EU and still significantly hamper the proper conduct of conformity assessment 
by notified bodies. 

If not addressed, this situation would lead to a significant disruption in the supply of 
a  multitude  of  in  vitro  diagnostic  medical  devices  on  the  market  both  for  health 
institutions and for the public. 

7  In accordance with the Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro 
diagnostic medical devices (see below footnote 16), Commission departments requested regular updates from 
industry and notified bodies  on the  preparedness of  various stakeholders  with  the aim of detecting possible 
barriers that could lead to shortages of devices on the market. 

8  See  list of designated notified bodies in the  NANDO  (new approach  notified and designated organisations) 
https://ec.europa.eu/growth/tools-

information 
databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35 

system. 

9  The Commission Notice on the application of Sections 2.3 and 3.3 of Annex IX to Regulation (EU) 2017/745 
and  Regulation  (EU)  2017/746  with  regard  to  notified  bodies’  audits  performed  in  the  context  of  quality 
management system assessment (OJ C 8, 11.1.2021, p.1) addresses the possibility to carry out remote audits 
instead  of  on-site  audits  as  temporary  extraordinary  measures  taken  in  response  to  the  exceptional 
circumstances of the COVID-19 pandemic.  

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The  European  Parliament,  in  a  cross-party  letter  of  11 May 2021  signed  by  several 
political groups (EPP, S&D, Renew, ECR, GUE/NGL, Greens),  and the Council of 
Health  Ministers  (EPSCO)  of  15 June 202110,  called  on  the  Commission  to  present 
an  urgent  legislative  proposal  to  smooth  the  transition  to  the  new  regulatory 
framework and to ensure the availability of in vitro diagnostic medical devices on the 
EU  market.  Stakeholders  representing  the  medical  device  industry,  notified  bodies, 
healthcare  professionals  and  researchers  in  the  field  of  clinical  chemistry  and 
laboratory  medicine,  and  not-for-profit  blood  establishments  also  called  for  urgent 
action. 

The  Commission  recognises  the  need  to  ensure  both  a  high  level  of  safety  and 
performance  of  devices,  and  their  availability  on  the  EU  market.  The  proposal 
therefore  aims  to  extend  the  existing  transitional  period  for  devices  covered  by  a 
certificate  issued  under  Directive  98/79/EC  and  to  introduce  tailored  transitional 
periods for devices that have to undergo a conformity assessment involving notified 
bodies  for  the  first  time  under  Regulation  (EU)  2017/746.  As,  since  its  outbreak, 
many health institutions, in particular hospitals, have had to focus all their efforts on 
dealing  with  COVID-19,  the  Commission  proposes  to  also  introduce  a  transitional 
period  for  the  requirements  for  devices  manufactured  and  used  within  the  same 
health institution (‘in-house devices’). This will give health institutions extra time to 
comply  with  the  new  requirements  and  ensure  that  in-house  tests,  which  are  often  
essential  –especially  for  rare  diseases,  can  continue  to  be  developed  in  clinical 
laboratories11.  

• 

Consistency with existing policy provisions in the policy area 

Regulation (EU) 2017/746 was adopted together with Regulation (EU) 2017/745 on 
medical devices12. In April 2020, due to the extraordinary circumstances caused by 
the COVID-19 pandemic and to prevent shortages or delays in the supply of medical 
devices  needed  for  patients  and  healthcare  professionals,  the  European  Parliament 
and  the  Council  adopted  a  Regulation13  postponing  the  date  of  application  of 
Regulation (EU) 2017/745 by 1 year until 26 May 2021, keeping the end date of the 
transitional  period  for  the  validity  of  certain  EC  declarations  of  conformity  and 
notified  body  certificates  issued  under  the  repealed  Directives  90/385/EEC  and 
93/42/EEC as 26 May 2024. 

For Regulation (EU) 2017/746, postponing the date of application by 1  year would 
not  resolve  the  challenges  linked  to  its  implementation.  As  the  main  challenge  to 

10  See  point  29  of  the  Council  Conclusions  on  Access  to  medicines  and  medical  devices  for  a  stronger  and 

resilient EU, approved by the Council (EPSCO) at its meeting of 15 June 2021, 9750/21.  

11  According  to  a  study  conducted  at  the  university  hospital  (UZ)  Leuven  (Belgium),  47%  tests  used  by  the 
clinical laboratory are in house tests, 42% are CE marked tests and 11% are modified or off-label CE marked 
tests. However nearly 98% of the results were generated with CE marked tests. See Vermeersch P, Van Aelst 
T, Dequeker EMC. The new IVD Regulation 2017/746: a case study at a large university hospital laboratory 
in  Belgium  demonstrates  the  need  for  clarification  on  the  degrees  of  freedom  laboratories  have  to  use  lab-
developed tests to improve patient care. Clin Chem Lab Med. 2020 Jul 21;59(1):101-106. doi: 10.1515/cclm-
2020-0804. PMID: 32692695.  

12  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. 

13  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. 

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market  readiness  is  the  limited  notified  body  capacity,  the  number  of  devices  that 
need to undergo a conformity assessment involving a notified body should be spread 
over  a  longer  period,  allowing  for  a  gradual  phase-in  of  the  new  Regulation’s 
requirements  while  prioritising  high-risk  in  vitro  diagnostics.  This  can  be  achieved 
by  amending  Article  110  of  the  Regulation  on  transitional  provisions,  providing  a 
period for existing higher risk class devices that is shorter than the one for existing 
lower risk class devices. At the same time, the existing transitional period for devices 
covered  by  notified  body  certificates  issued  under  Directive  98/79/EC  should  be 
extended  by  1  year  until  26 May 2025.  This  will  avoid  that  the  transitional  periods 
under  Regulation  (EU)  2017/745  and  Regulation  (EU)  2017/746  end  at  the  same 
time and lessen the strain on Member States’ competent authorities, notified bodies, 
manufacturers,  health  institutions  and  other  actors  who  deal  with  both  medical 
devices and in vitro diagnostics. 

2. 

• 

LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY 

Legal basis 

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

• 

Subsidiarity 

According  to  the  principle  of  subsidiarity,  EU  action  may  only  be  taken  if  the 
envisaged  aims  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  any 
potential disruption in the supply of devices, to ensure the smooth functioning of the 
internal market, and to ensure a high level of health protection for patients and users. 

• 

Proportionality 

The  proposed  EU  action  is  necessary  to  ensure  that  all  involved  parties  fully 
implement and apply Regulation (EU) 2017/746, taking into account the magnitude 
of  the  COVID-19  pandemic  and  the  associated  public  health  crisis.  The  proposed 
amendments  aim  to  ensure  that  the  intended  purpose  of  Regulation  (EU)  2017/746 
can  be  attained.  That  purpose  is  to  establish  a  robust,  transparent,  predictable  and 
sustainable  regulatory  framework  for  in  vitro  diagnostic  medical  devices,  which 
guarantees  a  high  level  of  protection  of  public  health  and  patient  safety  and  the 
smooth functioning of the internal market for such devices. 

The proposal maintains the objective of Regulation (EU) 2017/746 to ensure a high 
level of safety and performance of devices by enhancing their oversight by notified 
bodies  and,  in  the  case  of  in-house  devices,  by  setting  uniform  requirements  for 
health institutions. It only provides for the necessary additional time to achieve this 
objective. The proposal is proportionate in that it aims to address the main problem, 
i.e. that due to shortage of notified body capacity a large number of existing in vitro 
diagnostics may disappear from the market. Therefore, the proposed amendments are 
limited  to  allowing  a  gradual  phase-in  of  the  requirements,  without  altering  the 
substance  of  Regulation  (EU)  2017/746.  They  focus  on  existing  devices  that  need 
notified body involvement and on in-house devices. The proposed amendments will 
not delay the application of the Regulation to CE marked in vitro diagnostic medical 
devices that do not require the involvement of a notified body (i.e. class A non-sterile 

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devices  which  represent  around  20%  of  the  market14)  and  to  ‘new’  in  vitro 
diagnostics (i.e. those not covered by a certificate or declaration of conformity issued 
under Directive 98/79/EC). Regulation (EU) 2017/746 is envisaged to apply in full to 
those devices from 26 May 2022. 

The  Commission  proposes  to  differentiate  between  higher  (i.e.  class  D  and  C 
devices)  and  lower  (i.e.  class  B  and  A  sterile  devices)  risk  devices,  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  with  high  level  of 
public health protection. 

It  also  takes  into  consideration  the  interest  of  notified  bodies  to  continue  receiving 
applications  for  certification,  rewarding  the  investment  they  have  made  to  be 
designated under Regulation (EU) 2017/746. 

• 

Choice of the instrument 

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

3. 

RESULTS 
CONSULTATIONS AND IMPACT ASSESSMENTS 

EX-POST 

EVALUATIONS, 

OF 

STAKEHOLDER 

This  proposal  is  not  accompanied  by  a  separate  impact  assessment,  as  an  impact 
assessment was already carried out when preparing Regulation (EU) 2017/746. This 
proposal does not alter Regulation (EU) 2017/746 in substance and does not impose 
new obligations on the concerned parties. It primarily aims to amend the transitional 
provisions,  allowing  for  a  progressive  rollout  of  the  Regulation’s  requirements,  for 
exceptional reasons in the context of the COVID-19 pandemic. 

The exceptional circumstances and the need to act quickly to ensure certainty ahead 
of  the  Regulation’s  application  date  did  not  allow  for  a  broad  public  consultation. 
The  Commission  therefore  collected  the  necessary  input  from  Member  States  and 
stakeholders through targeted exchanges.  
In  cooperation  with  the  Medical  Device  Coordination  Group  (MDCG)15,  the 
Commission’s  Directorate-General  for  Health  and  Food  Safety  (DG  SANTE)  drew 
up  a  joint  implementation  plan16  identifying  essential  and  high-priority  actions  for 
the  implementation  of  Regulation  (EU)  2017/746.  The  plan  includes  monitoring 
activities  and  contingency  planning  to  address  potential  bottlenecks  and  other 
transitional  issues.  The  plan  will  be  continuously  implemented  and  updated,  also 
after the adoption of the proposed amendment to Regulation (EU) 2017/746. 

14  MedTech Europe Survey Report, see footnote 2. 
15  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 
code  X03565. 
of 
is 
https://ec.europa.eu/transparency/expert-groups-register/screen/expert-
groups/consult?lang=en&groupID=3565 

the  Commission’s 

groups  with 

register 

expert 

listed 

the 

in 

16  Joint  implementation  and  preparedness  plan  for  Regulation  (EU)  2017/746  on  in  vitro  diagnostic  medical 
devices  (IVDR)  (June  2021).  https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_joint-impl-
plan_en.pdf. 

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The market surveys conducted in 2021 demonstrated the need for legislative action. 
Data  available  to  the  Commission,  provided  by  notified  bodies  and  by  the  trade 
association MedTech Europe, covering around 90% of the in vitro diagnostic market 
revenue, showed the following situation: 

Directive 98/79/EC 

Regulation (EU) 2017/746 

around  40 000  different  in  vitro  diagnostic 
medical devices available on the market 

around  31 000  different  in  vitro  diagnostic 
medical  devices  expected  to  be  available  on 
the  market  (the  industry  expects  that  nearly 
9 000  devices  currently  available  on  the 
market  will  not  be  CE  marked  under 
Regulation (EU) 2017/746, which would be a 
drop of 22%) 

around  3 300  in  vitro  diagnostic  medical 
devices needed the involvement of a notified 
body (i.e. about 8% of IVDs on the market)  

  around  2 500  IVDs  falling  under 

over  24 000  in  vitro  diagnostic  medical 
devices  will  need  the  involvement  of  a 
notified  body  (i.e.  about  78%  of  all  IVDs 
expected to enter the market) 

Annex II to Directive 98/79/EC 

  around 1 200 class D IVDs (=4%) 

  around 800 IVDs for self-testing 

  around 7 860 class C IVDs (=25%) 

1 545 certificates issued by notified bodies  

  around 14 890 class B IVDs (=49%) 

  around  340  class  A  sterile  IVDs 

(=0.01%) 

31  certificates  issued  by  notified  bodies 
covering roughly 1 300 devices (mainly class 
B  and  C  devices;  no  certificates  issued  for 
class D devices)17; 

around  520  applications  for  certification 
received by  notified bodies covering roughly 
9 600 devices (mainly class B and C devices);  

for  about  95%  of  IVDs  requiring 
the 
involvement  of  a  notified  body  certificates 
are yet to be issued, including for all class D 
devices 

(state of play 9.9.2021)  

22 notified bodies designated (18 after UK’s 
withdrawal from the EU) 

6  notified  bodies  designated,  11  applications 
pending (September 2021) 

17  The  MedTech Europe Survey Report states that 2 848  in vitro diagnostic  medical devices  were covered by 
certificates, including 156 class D devices, 1 491 class C devices, 1 220 class B devices and 11 class A sterile 
devices.  

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On 28 January and 27 July 2021, DG SANTE organised meetings with the MDCG to 
discuss  the  joint  implementation  plan,  in  particular  the  challenges  to  implementing 
the Regulation and the most suitable approach to take for a legislative initiative.  

In addition to the regular exchanges with stakeholders throughout the year, targeted 
discussions  on  a  possible  legislative  initiative  were  held  in  September  2021  with 
representatives  of  notified  bodies,  the  European  medical  device  industry,  health 
institutions, health professionals, laboratories, patients and consumers. 

Comments  received  from  all  those  involved  have  been  considered  and  taken  into 
account to the extent possible while balancing various interests at stake. 

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. 

4. 

BUDGETARY IMPLICATIONS 

The proposed action has no budgetary implications. 

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2021/0323 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EU) 2017/746 as regards transitional provisions for certain in 
vitro diagnostic medical devices and deferred application of requirements for in-house 
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) 

(2) 

1 

2 

Regulation (EU) 2017/746 of the European Parliament and of the Council1 establishes 
a new regulatory framework to ensure the smooth functioning of the internal market as 
regards  in  vitro  diagnostic  medical  devices  covered  by  that  Regulation,  taking  as  a 
base a high level of protection of health for patients and users, and taking into account 
the  small-  and  medium-sized  enterprises  that  are  active  in  this  sector.  At  the  same 
time, Regulation (EU) 2017/746 sets high standards of quality and safety for  in vitro 
diagnostic medical devices in order to meet common safety concerns as regards such 
devices. Furthermore, Regulation (EU) 2017/746 significantly reinforces key elements 
of the existing regulatory approach in Directive 98/79/EC of the European Parliament 
and of the Council2, such as the supervision of notified bodies, conformity assessment 
procedures,  performance  evaluation  and  performance  studies,  vigilance  and  market 
surveillance,  whilst  introducing  provisions  ensuring  transparency  and  traceability 
regarding in vitro diagnostic medical devices. 

The  COVID-19  pandemic  and  the  associated  public  health  crisis  presented  and  still 
presents  an  unprecedented  challenge  to  Member  States  and  constitutes  an  immense 
burden for national authorities, health institutions, Union citizens, notified bodies and 
economic operators. The public health crisis  has created extraordinary circumstances 

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). 
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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(3) 

(4) 

that demand substantial additional resources, as well as increased availability of vitally 
important  in  vitro  diagnostic  medical  devices,  that  could  not  reasonably  have  been 
anticipated at the time of adoption of Regulation (EU) 2017/746. Those extraordinary 
circumstances have a significant impact on various areas covered by that Regulation, 
such as the designation and work of notified bodies and the placing on the market and 
making available on the market of in vitro diagnostic medical devices in the Union. 

In  vitro  diagnostic  medical  devices  are  essential  for  the  health  and  safety  of  Union 
citizens  and  SARS-CoV-2  tests,  in  particular,  are  vital  for  the  fight  against  the 
pandemic. Therefore, it is necessary to ensure an uninterrupted market supply of such 
devices in the Union. 

Given the unprecedented magnitude of the current challenges, the additional resources 
needed  from  Member  States,  notified  bodies,  economic  operators,  health  institutions 
and  other  relevant  parties  in  order  to  fight  the  COVID-19  pandemic  and  the  current 
limited  capacity  of  notified  bodies,  and  taking  into  account  the  complexity  of 
Regulation  (EU)  2017/746,  it  is  very  likely  that  Member  States,  health  institutions, 
notified bodies, economic operators and other relevant parties will not be in a position 
to  ensure  the  proper  implementation  and  full  application  of  that  Regulation  from  26 
May 2022 as laid down therein. 

(5)  Moreover,  the  current  transitional  period  provided  for  in  Regulation  (EU)  2017/746 
regarding  the  validity  of  certificates  issued  by  notified  bodies  for  in  vitro  diagnostic 
medical devices under Directive 98/79/EC will end on the same day as the transitional 
period provided for in Regulation (EU) 2017/745  of the European Parliament and of 
the  Council3  regarding  the  validity  of  certain  EC  declarations  of  conformity  and 
certificates issued by notified bodies for medical  devices  under the repealed Council 
Directives 90/385/EEC4 and 93/42/EEC5, that is on 26 May 2024. This puts a strain on 
actors who deal with both medical devices and in vitro diagnostic medical devices. 

(6) 

(7) 

In  order  to  ensure  the  smooth  functioning  of  the  internal  market  and  a  high  level  of 
protection of public health and patient safety, as well as to provide legal certainty and 
avoid potential market disruption, it is necessary to extend the transitional periods laid 
down  in  Regulation  (EU)  2017/746  for  devices  covered  by  certificates  issued  by 
notified bodies under Directive 98/79/EC. For the same reasons, it is also necessary to 
provide  a  sufficient  transitional  period  for  devices  which  are  to  undergo  conformity 
assessment  involving  a  notified  body  for  the  first  time  under  Regulation  (EU) 
2017/746. 

For  the  period  of  time  needed  to  expand  the  capacity  of  notified  bodies,  a  balance 
should  be  struck  between  the  limited  available  capacity  and  a  high  level  of  public 
health  protection.  Therefore,  the  transitional  periods  for  in  vitro  diagnostic  medical 
devices  that  are  to  undergo  conformity  assessment  involving  a  notified  body  for  the 
first  time  under  Regulation  (EU)  2017/746  should  differentiate  between  higher  and 
lower  risk  devices.  The  length  of  the  transitional  period  should  depend  on  the  risk 

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). 
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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(8) 

(9) 

class of the device concerned so that the period is shorter for devices of a higher risk 
and longer for devices of a lower risk class. 

In order to allow in vitro diagnostic medical devices which are placed on the market in 
accordance with the transitional provisions laid down in this Regulation sufficient time 
to be further made available on the market, including to be supplied to the end users, 
or to  be put  into service, the sell-off date provided for in  Regulation  (EU) 2017/746 
should be adapted to take into account the additional transitional periods. 

Having regard to the resources required from health institutions in the fight against the 
COVID-19 pandemic, those institutions should be given additional time to prepare for 
the specific requirements laid down in Regulation (EU) 2017/746 for the manufacture 
and  use  of  devices  within  the  same  health  institution  (‘in-house  devices’).  The 
application  of  those  requirements  should  therefore  be  deferred.  As  the  health 
institutions will need a complete overview of CE marked  in vitro diagnostic medical 
devices available on the market, the requirement to provide justification that the target 
patient  group’s  needs  cannot  be  met,  or  cannot  be  met  at  the  appropriate  level  of 
performance, by a device available on the market should not become applicable until 
the transitional periods laid down in this Regulation have ended. 

(10)  Regulation (EU) 2017/746 should therefore be amended accordingly.   

(11)  Since  the  objectives  of  this  Regulation,  namely  to  extend  the transitional  periods  set 
out in Regulation (EU) 2017/746, to introduce additional transitional provisions in that 
Regulation and to defer the application of the provisions of that Regulation concerning 
in-house devices, 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. 

(12)  The  adoption  of  this  Regulation  takes  place  under  exceptional  circumstances  arising 
from  the  COVID-19  pandemic  and  the  associated  public  health  crisis.  To  attain  the 
intended  effect  of  amending  Regulation  (EU)  2017/746  as  regards  the  transitional 
periods and the date of application of the provisions on in-house devices, in particular 
in  view  of  providing  legal  certainty  for  economic  operators,  it  is  necessary  for  this 
Regulation  to  enter  into  force  before  26  May  2022.  It  was  therefore  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 TEU, to the Treaty on the Functioning of the European Union and to the Treaty 
establishing the European Atomic Energy Community. 

(13) 

In  light  of  the  overriding  need  to  immediately  address  the  public  health  crisis 
associated with the COVID-19 pandemic, this Regulation should enter into force as a 
matter of urgency on the day of its publication in the Official Journal of the European 
Union, 

HAVE ADOPTED THIS REGULATION: 

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

(1) 

Article 110 is amended as follows: 

Article 1 

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(a) 

paragraph 2 is amended as follows: 

(i) 

(ii) 

in the first subparagraph, the date ‘27 May 2024’ is replaced by ‘27 May 
2025’; 

in  the  second  subparagraph,  the  date  ‘27  May  2024’  is  replaced  by  ‘27 
May 2025’; 

(b)  paragraphs 3 and 4 are replaced by the following: 

‘3.  By  way  of  derogation  from  Article  5  of  this  Regulation,  the  devices 
referred to in the second and third subparagraphs of this paragraph may 
be placed on the market or put into service until the dates set out in those 
subparagraphs,  provided  that  from  the  date  of  application  of  this 
Regulation  they  continue  to  comply  with  Directive  98/79/EC  and 
provided that there are no significant changes in the design and intended 
purpose. 

Devices  with  a  certificate  that  was  issued  in  accordance  with  Directive 
98/79/EC and which is valid by virtue of paragraph 2 of this Article may 
be placed on the market or put into service until 26 May 2025. 

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 
the 
to 
assessment  procedure  pursuant 
involvement of a notified body, may be placed on the market or put into 
service until the following dates: 

this  Regulation 

requires 

(a) 

26 May 2025 for class D devices; 

(b)  26 May 2026 for class C devices; 

(c) 

26 May 2027 for class B devices; 

(d)  26  May  2027  for  class  A  devices  placed  on  the  market  in  sterile 

condition. 

However,  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  first, 
second and third subparagraph instead of the corresponding requirements 
in Directive 98/79/EC. 

Without  prejudice  to  Chapter  IV  and  paragraph  1  of  this  Article,  the 
notified  body  that  issued  the  certificate  referred  to  in  the  second 
subparagraph  of  this  paragraph  shall  continue  to  be  responsible  for  the 
appropriate surveillance in respect of all applicable requirements relating 
to the devices it has certified. 

4.  Devices  lawfully  placed  on  the  market  pursuant  to  Directive  98/79/EC 
prior to 26 May 2022 may continue to be made available on the market 
or put into service until 26 May 2025. 

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 until the following dates: 

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(a) 

26  May  2026  for  devices  referred  to  in  paragraph  3,  second 
subparagraph, or in paragraph 3, third subparagraph, point (a); 

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

subparagraph, point (b); 

(c) 

26  May  2028  for  devices  referred  to  in  paragraph  3,  third 
subparagraph, points (c) and (d).’; 

(2) 

in Article 112, second subparagraph, the date ‘27 May 2025’ is replaced by ‘26 May 
2028’; 

(3) 

in Article 113(3), the following points (i) and (j) are added: 

‘(i)  Article 5(5), points (b), (c) and (e) to (i), shall apply from 26 May 2024; 

(j)  Article 5(5), point (d), shall apply from 26 May 2028.’. 

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

Article 2 

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

Done at Brussels, 

For the European Parliament 
The President 

For the Council 
The President 

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