EN   EN 
 
 
 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)   EN 1  EN EXPLANATORY MEMORANDUM  
1. 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 ob jectives 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 Regulation s 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 Counci l 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 ex tension 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 
 
1 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).  
2 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 ). 
3 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 a pplication 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 . 
4 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). 
5 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 applicati on of conditions for in -house devices (OJ L 19, 28.1.2022, p. 3).  EN 2  EN modules is completed. The use of Eudamed – and especial ly 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 fr om 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 o f 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 calc ulation 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.   
 
6 Rohr, Ulrich -Peter, et al., ‘The Value of In Vitro Diagnostic Testing in Medical Practice: A Status 
Report ’, PLOS ONE  11(3): e0149856 (2016) . 
7 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).  
8 MedTech Europe Survey Report – Analysing the availability of In vitro Diagnostic Medical Devices 
(IVDs) in May 2022 when the new EU IVD Regulation 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/ . 
9 Based on data received from notified bodies in October 2022.  
10 Based on data received from notified bodies in October 2022.  
11 Transition to the IVD Regulation – MedTech Europe Survey Results for October 2022 , 
https://www.medtecheurope.org/wp -content/uploads/2023/02/230220_public -report -ivdr-
survey_di35.pdf . EN 3  EN 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 transition al period remaining for classes C, B 
and A sterile, the transition al 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 conf ormity 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 i f 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 tra nsition al 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 result ing 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 des ignated 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 
average duration of the conformity assessment process combining quality 
management system and te chnical 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 
 
12 Based on preliminary data received from n otified bodies in December 2023.  
13 See list of designated notified bodies in the  NANDO  (new  approach notified and designated 
organisations)  information  system, EUROPA – European Comm ission – Growth – Regulatory policy - 
SMCS . 
14 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 Results fo r October 2022 , https://www.medtecheurope.org/wp -
content/uploads/2023/02/230220_public -report -ivdr-survey_di35.pdf . 
15 Notified bodies survey on certifications and applications, https://health.ec.europa.eu/system/files/2023 -
11/md_nb_survey_certifications_applications_en.pd f. EN 4  EN notified bo dies 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 transition al 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, includ ing 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 specificatio ns 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 attent ion 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 capac ity 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 docu mentation 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 l imited, 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 perspecti ve 
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 i n 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 hig h safety standards  will benefit from the 
additional time. In addition, at the latest by 26 May 2025, all manufacturers will have 
 
16 https://www.medtecheurope.org/wp -content/uploads/2023/10/the -european -medical -technology -
industry -in-figures_2023 -1.pdf .  
17 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).  
18 https ://nobocap.eu/   EN 5  EN 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 
under lying 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 t o 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 an d 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 
features specified by the Regulations: UDI/Devices, Actors, Notified 
bodies/Certificates, Post -Mark et Surveillance and Vigilance, Market Surveillance, 
and Clinical investigations/Performance studies . 
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 to be completed in Q2/2024. The last module (Clinical 
investigations/Performance studies) will not be completed before Q3/2026. Pursuant 
to the current MDR rules, Eu damed 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 e lectronic 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 .  
 
19 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.    
20 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.  EN 6  EN  
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 te rms of resource saving s for manufacturers 
as it prevents multiple registration s 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 dec lared 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 asses sment 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 manufacturer s 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 
EN 7  EN 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 ensur e 
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 20 23 Regulation (EU) 2023/60721 extend ing 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 audi ts23, 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, t he Commission adopted two delegated acts deferring the first 
comple te 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  transition al 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 
 
21 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 t he transitional provisions for certain medical 
devices and in vitro  diagnostic medical devices  (OJ L 80, 20.3.2023, p. 24). 
22 MDCG position paper  MDCG 2022 -14, Transition to the MDR and IVDR – Notified body capacity and 
availability of medical devices and IVDs  (August 2022).  
23 MDCG 2022 -17, MDCG position paper on ‘hybrid audits’  (December 2022) . 
24 MDCG 2022 -15, Guidance on appropriate surveillance regarding the transitional provisions under 
Article 110 IVDR with regard to devices covered by certificates according to t he IVDD  (September 
2022); MDCG 2022 -4 rev. 1 , Guidance on appropriate surveillance regarding the transitional 
provisions under Article 120 MDR with regard to devices covere d by certificates according to the MDD 
or the AIMDD  (December 2022) . 
25 MDCG 2019 -6 Rev.4 , Questions and answers:  Requirements relating to notifi ed bodies  (October 
2022).  
26 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). 
27 E.g. under the 2022 EU4Health work programme : a call for proposals aim ing 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 d irect 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-
 EN 8  EN 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 l evel 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 r isk 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, predicta ble 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 o f 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 num ber 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 a nd 
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. 
 
23-63); and call for proposals for a program me 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). 
28 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).   EN 9  EN 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 a s 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  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
• 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 prop osals 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 singl e 
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 elect ronic 
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 subg roups. 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 Art icle 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 Regu lations, 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 underp erforming in ensuring availability of devices for small EN 10  EN 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 short ages 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. OTH ER 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 measu res to ensure patient health and 
safety.  
It also amends  several pro visions 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 functio nal.  
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 timefra me.  
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 anticipate s 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 11  EN specific transitional provisions related to Eudamed in Article 1 10(8), Article 1 12 and 
Article 1 13(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 9 8/79/ EC that were valid on the day of the 
IVDR ’s date of application (26 May 202 2) and have not been withdrawn by a 
notified body. The extension is  directly applicable, so that notified bodies are not 
required to change the date on the individual certificates. The length of the extension 
of the certificate’s validity corresponds to the length of the extended transition al 
period laid down in the propo sed Article 1 10(3) to (3 b). 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 noti fied 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 as sessment procedure in accordance with 
Article 5 4 or have required the manufacturer to carry out the conformity assessment 
procedure within a specific time period in accordance with Article 9 2. 
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 3 e. The staggering o f the 
transition period s is kept, extend ing 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 1 10(3);  
○ the devices do not undergo significant changes in the design and intended 
purpose. This condition is already part of the current Article 1 10(3);  
○ the devices do not present an unacceptable risk to the healt h 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 9 0 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 . Whe re, 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 202 5, 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 12  EN declaration nor verification of the appropriateness of the QMS by a notified 
body, is required at this stage ; 
○ by a spe cific date ( 26 May 20 25, 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 ce rtificate or declaration of conformity, or in respect of a device 
intended to substitute that device under the IVDR. Within four months, s uch 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(3 c). In this way, unnecessary applications for certification of devices that 
will in any case be phased out and replaced by a new generation o f 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 issue d 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 noti fied 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 13  EN 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) 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 regar ds 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 dev ices 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 
 
1 OJ C , , p. .  
2 OJ C , , p. .  
3 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 ). 
4 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 , ELI: http://data .europa.eu/eli/reg/2017/746/oj ). 
5 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, 20.7.1 990, p. 17 , ELI: 
http://data.europa.eu/eli/dir/1990/385/oj ).  
6 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 ).  EN 14  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, a nd require the set ting 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 . 
(2) Regulations (EU)  2017/745  and (EU)  2017/746  require the Commission to set up, 
maintain and manage Eudamed , which includes s even  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, t he 
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 implement ed.  
(3) Pursuant to Regulation s (EU)  2017/745  and (EU)  2017/74 6, 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 effe ct. The delay ed development of the last electronic system therefore holds back 
the mandatory use of the electronic systems that are available.  
(4) 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 ind ividual electronic systems of Eudamed should 
therefore be allowed  once  their functio nality has been verified in accordance with the 
procedure laid down in Regulation (EU) 2017/74 5. 
(5) 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 .  
(6) Due to the delay of the development of the electronic system on clinical investigations 
and performance studi es, 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 .  
(7) 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 suf ficient 
to ensure the certification of the large number of devices which are to undergo 
conformity assessment involving a notified body under that Regulation .  
(8) 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 .  
(9) 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 
 
7 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 , ELI: 
http://data.europa.eu/eli/dir/1998/79/oj ).  EN 15  EN accordance with Regulation (EU) 2017/746 before the end of the transitional period s. 
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 . 
(10) In order to ensure a high level of protection of public health and patient safety, while 
safeguarding the smooth functioning of the i nternal 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 b odies 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 a ny impediment to the certification process .  
(11) The extension should be of sufficient duration to give manufacturers and notified 
bodies the time ne cessary to carry out the required conformity assessments. The 
extension should aim to ensure a high level of public health protection, including 
patient saf ety 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 perio d. 
(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 
Direc tive 98/79/EC to a notified body designated under Regulation (EU)  2017/74 6. 
For reasons of legal certainty, the notified body designated under Regulation 
(EU)  2017/74 6 should not be responsible for conformity assessment and surveillance 
activities carried out by the notified body that issued the certificate . 
(14) As regards the period s needed to allow manufacturers and notified bodies to carry out 
the conformity assessment in accordance with Regulation (EU)  2017/74 6 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  institution s to take mitigating 
measures where necessary to ensure patient health and safety . Therefore, w here 
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 16  EN competent authorities as well as the economic operators to whom they directly suppl y 
the device and, where applicable, the health institutions or healthcare professionals to 
whom they directly suppl y the device , thereof . The risk of serious harm to patient s 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 al ternatives, 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 manuf acturer and other economic operators in the 
downstream supply chain until it reaches the relevant health institution s or healthcare 
professionals . As the risk of shortage s 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 m edical 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 t he 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 obj ectives.  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 
to attain the intended effect of amending Regulations (EU)  2017/745 and 
(EU) 2017/746 and to ensure availability of devices whose certificates have already 
expired or are due to expire before 26  May 202 5, to provide legal certainty for 
economic operators and healthcare providers, and for reasons of consistency as regards 
the ame ndments 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 ro le 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 . 
(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  
Amendments to Regulation (EU) 2017/745  
Regulation (EU) 2017/745 is amended as follows:  EN 17  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 ope rators, health 
institutions and healthcare professionals to whom the manufacturer directly 
supplie s the device , of the anticipated  interruption.  
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.  
2. 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.  
3. The economic operators who have received the information from the 
manufa cturer in accordance with  paragraph 1 , shall inform without undue 
delay any other economic operators, health institutions and healthcare 
professionals to whom they directly suppl y the device of the anticipated 
interruption.’  
(2) Article 34 is amended as f ollows:  
(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 t he 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 th e 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 b y 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 1 3 is added : EN 18  EN ’13. Article 10a shall apply also to d evices 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 
corre sponding 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 Direc tive 93/42/EEC , and the obligations relating 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 re ferred 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 ;’;  
(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 obligation s of the Commission pursuant to 
Article 34, the obligations and requirements that relate to any of the 
electronic systems referred t o 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) inform ing 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 follow ing indent is inserted : 
‘- Article 56(5),’;  
(iii) the fourteenth indent is replaced by the f ollow ing: 
‘- Article 78(1)  to (13), without prejudice to Article 78(14), ’; 
(iv) 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 
Directives  90/385/EEC and 93/42/EEC regarding  information on 
vigilance reporting, clinical investigations, registration of devices and 
economic operators, and certificate notifications shall continue to apply .’; 
(b) point (e) is replaced by the following : EN 19  EN ‘(e) no later than 6 months after the date refer red 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 s ame devices are placed on marke t also from  
the date refer red to in point (d)  of this paragraph : 
(i) device s, other than custom -made devices , for which the 
manufacturer has undertaken a conformity assessment in 
accordance with Article 52 ; 
(ii) 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 accord ance with Article 52, is already registered in 
Eudamed ;’; 
(c) the following p oints are inserted after point (e) : 
‘(ea) no later than 12 months after the date refe rred 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 p oint (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 obligation s 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 p oint (e) of this paragraph  when the certificate  is entered  in 
Eudamed  in accordance with p oint (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 20  EN ‘Article 10a 
Obligations in case of i nterruption 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 th is 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 au thorised 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 .  
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.  
2. The competent authority that has recei ved 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 .  
3. 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 suppl y the device of the anticipat ed 
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 tha t 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 202 2 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 th at 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 Regulatio n] 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 21  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 S tate 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 conform ity 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 202 7. 
3b. Devices for which the conformity a ssessment 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 proced ure 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) 31 December 202 7, for class D devices;  
(b) 31 December 202 8, for class C devices;  
(c) 31 December 20 29, 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 22  EN or in respect of a device intended to substitute that device, no later 
than:  
(i) 26 May 2025, for devices referred to in p aragraph 3a and 
paragraph 3b, point (a);  
(ii) 26 May 20 26, 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 surveil lance, 
vigilance, registration of economic operators and of devices shall apply 
to devices referred to in the paragraph s 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 that the latter  shall carry out such 
surveillance.  
No later than 26 September 2025 , the notified body that has signed the 
written agreement referred to in paragraph 3c, point ( f), shall be come  
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 certific ate 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 t he 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 23  EN (e) the following paragra ph 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 repeale d with effect 
from 26  May 202 2, 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 o perators, 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 obligation s 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 24  EN functional sp ecifications 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, performa nce 
studies , registration of devices and economic operators, and certificate 
notifications shall continue to apply.’ ; 
(c) the following p oints are inserted  after point (f) : 
‘(fa) no later than 6 months after the date refer red to in point (f)  of this 
paragr aph, 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 1 10(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 refer red to in point ( f) of this 
paragraph , notified bodies shall ensure that th e 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 p oint 
(fa), (i),  of th is 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 5 0(1) of this 
Regulation , through the electronic system r eferred 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 p oint (fb) of this paragraph ; EN 25  EN (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 8 2 or submit a tren d 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 ref erred 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 ent ry 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  For the Council  
The President  The President