EN   EN 
 
 
 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)   EN 1  EN EXPLANATORY MEMORANDUM  
1. 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 m arket 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 bod y 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 ad ditional 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 dev ices 
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.  
2 MedTech Europe Survey Report analysing the availability of In vitro  Diagnostic Medical Devices (IVDs) in 
May 2022 when the new EU IVD Regulation applies, 8 September 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  
3 Directive 98/79/EC of the European Parliament a nd 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 assessm ent 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 noti fied 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.  EN 2  EN 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. F or 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 trave l 
restrictions and quarantine orders . 
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 th at Member States, health 
institutions, notified bodies and economic operators will not be in a position to 
ensure the proper implementation and application of the Regulation from 
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 establishe d 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 additio n, 
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 regio ns 
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 m arket 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 devic es on the market.  
8 See list of designated notified bodies in the NANDO (new approach notified and designated organisations)  
information  system. https://ec.europa.eu/growth/tools -
databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=35  
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) addresse s 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.   EN 3  EN 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 devic e 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 thei r 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 tim e 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  
Regula tion (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 validit y 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 me dical 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 hou se 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 larg e 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. P MID: 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.  EN 4  EN 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, al lowing 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 cla ss 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 
amen dment 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 regulat ory 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 (E U) 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 additi onal 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, th e 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 amend ments 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 EN 5  EN devices which represent around 20% of the market14) and to ‘new’ in vitr o 
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 capa city 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  OF EX-POST  EVALUATION S, STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
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 St ates 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 Comm ission. The MDCG 
is listed in the Commission’s register of expert groups with the code X03565. 
https://ec.europa.eu/transparency/expe rt-groups -register/screen/expert -
groups/consult?lang=en&groupID=3565  
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 . EN 6  EN 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 M edTech 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 
Annex II to Directive 98/79/EC  
 around 800 IVDs for self -testing  over 24 000 in vitro  diagnostic me dical 
devices will need the involvement of a 
notified body (i.e. about 78% of all IVDs 
expected to enter the market)  
 around 1  200 class D IVDs (=4%)  
 around 7  860 class C IVDs (=25%)  
 around 14  890 class B IVDs (=49%)  
 around 340 class A sterile IVDs 
(=0.01%)  
1 545 certificates issued by notified bodies  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 b odies 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 
certificat es, including 156 class D devices, 1 491 class C devices, 1 220 class B devices and 11 class A sterile 
devices.  EN 7  EN 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 initia tive 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 
stake holders about the need for complementary actions.  
4. BUDGETARY  IMPLICATIONS  
The proposed action has no budgetary implications.  EN 8  EN 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) 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 med ical 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 Counci l2, 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.  
(2) 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 citiz ens, notified bodies and 
economic operators. The public health crisis has created extraordinary circumstances 
                                                 
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 D irective 98/79/EC and Commission Decision 2010/227/EU 
(OJ L 117 5.5.2017, p. 176).  
2 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).  EN 9  EN that demand substantial additional resources, as well as increased availability of vitally 
important in vitro  diagnostic medical devices, that cou ld 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 th e placing on the market and 
making available on the market of in vitro  diagnostic medical devices in the Union . 
(3) 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.  
(4) Given the unprecedented magnitude of the current challenges, the additional resources 
needed from Member States, noti fied 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 like ly 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) More over, 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 t he 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 
Directive s 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) 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 per iods 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 confo rmity 
assessment involving a notified body for the first time under Regulation (EU) 
2017/746.  
(7) 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 Regulation (EU) 2 017/745 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, 5.5.2 017, p. 1).  
4 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).  
5 Council Directive 93/42/EEC of 14 June 1993 concerning medical d evices (OJ L 169, 12.7.1993, p.1).  EN 10  EN 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 . 
(8) 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 se rvice, the sell -off date provided for in Regulation (EU) 2017/746 
should be adapted to take into account the additional transitional periods.  
(9) Having regard to the resources required from health institutions in the fight against the 
COVID -19 pandemic, t hose 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 requir ements 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 amend ed 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 an d 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 
establish ing 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 
Unio n, 
HAVE ADOPTED THIS REGULATION:  
Article 1  
Regulation (EU) 2017/746 is amended as follows:  
(1) Article 110 is amended as follows:  EN 11  EN (a) paragraph 2 is amended as follows:  
(i) in the first subparagraph, the date ‘27 May 2024’ is replaced by ‘27 May 
2025’;  
(ii) 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 subparagrap hs 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 n o 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 
assessment procedure pursuant to this Regulation requires the 
involvement of a notified body, may be placed on the market or put into 
service until the following dates:  
(a) 26 May 2025 for class D devices;  
(b) 26 May 2026 for clas s 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 
notif ied 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:  EN 12  EN (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 device s 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.’.  
Article 2  
This Regulation shall enter into force o n the day of its publication in the Official Journal of 
the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The Presi dent