G/TBT/N/EU/1044  
31 January 2024  
(24-0757) Page: 1/3 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addit ion, where applicable):  Medical 
devices and in vitro  diagnostic medical devices  
5. Title, number of pages and language(s) of the notified document:  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 (COM(2024) 43 final); (26 page(s), in English)  
6. Description of content:  Regulation (EU) 2017/745 on medical devices (MD Regulation) 
and Regulation (EU) 2017/746 on in vitro diagnostics medical devices (IVD  Regulation) 
establish a new regulatory framework for medical devices and in vitro  diagnostic medical 
devices. Their objectives are a high level of protection of health for patients and users 
and the smooth functioning of the internal market for these prod ucts. 
The MD Regulation has been applicable since 26 May 2021. It was notified to the WTO as 
notification G/TBT/N/EU/71.  In March 2023, the European Parliament and the Council 
adopted a stagg ered extension of its transition period, ranging from 31 December 2027 
for high risk devices to 31 December 2028 for medium and lower risk devices. It was 
notified to the WTO as notification G/TBT/N/EU/943 . 
The IVD Regulat ion has been applicable since 26 May 2022. It was notified to the WTO 
as notification G/TBT/N/EU/72 . In January 2022, the European Parliament and the Council 
adopted a staggered extension of its transition period, ranging from 26 May 2025 for high 
risk in vitro  diagnostics to 26 May 2027 for lower risk in vitro  diagnostics. It was notified 
to the WTO as notification G/TBT/N/EU/845 . G/TBT/N/EU/1044  
 
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  Despite considerable progress over the past years, the capacities of confor mity 
assessment ('notified') bodies designated in accordance with the IVD Regulation remain 
insufficient and manufacturers are not sufficiently prepared to meet the strengthened 
requirements of the IVD Regulation on time. This is threatening the availabili ty of in vitro  
diagnostics on the EU market.  
This proposal extends the current transition period laid down in Article 110 of the IVD 
Regulation, based on certain conditions. The conditions would ensure that only devices 
that are safe and for which manufacturers have already taken steps to transition to the 
MDR will benefit from the additional time. This would give manufacturers and notified 
bodies more time to conduct the conformity assessment procedures in accordance with 
the IVD Regulation, if those conditions are fulfilled. The draft measure propos es to keep 
the staggering of the transition periods depending on the risk class of the device and 
proposes their extension until 2027 for class D IVDs, until 2028 for class C IVDs and until 
2029 for class B and class A sterile IVDs. The extension of the tr ansition period is 
complemented by an extension of the validity of certificates issued under the previous 
Directive 98/79/EC for the devices benefiting from the extended transition period. Also 
the validity of certificates that have already expired since 2 6 May 2022 would be extended 
under certain conditions.  
The proposal also aims to allow a gradual roll -out of the electronic systems integrated in 
EUDAMED that are finalised (e.g. systems for the registration of economic operators, 
devices and certificates) , instead of delaying the mandatory use of EUDAMED until the 
last of the six modules is completed. This way, the mandatory use of EUDAMED will be 
implemented stepwise and in a more timely manner.  
In addition, the proposal aims to introduce an information m echanism for signalling 
interruption of supply of certain medical devices and IVDs, where the manufacturer has 
reasons to believe that the interruption may lead to serious harm or pose a risk of serious 
harm to patients or public health.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The notified draft maintains the objectives of Regulations (EU) 2017/745 and 
(EU) 2017/746 to ensure a high level of safety and performance of devices by enhancing 
their oversight by noti fied bodies.  
It only provides for the necessary additional time to achieve this objective whilst ensuring 
the protection of human health and safety, in particular to prevent shortages of medical 
devices.  
Having regard to the usual length of conformity asse ssment procedures, the amendment 
to Regulation 2017/746 needs to be adopted as quickly as possible in order to ensure 
legal certainty for all actors, including manufacturers and notified bodies, ahead of the 
date on which the current transition period will  end for class D IVDs (26 May 2025). This 
notified draft extends its transitional provisions' timelines (regarding Regulation (EU) 
2017/746).  
Given the need for legal certainty and the short period for adoption of the measure, the 
commenting period has bee n reduced to 20 days; Protection of human health or safety  
8. Relevant documents:   
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).  
EUR-Lex - 02017R0745 -20200424 - EN - EUR-Lex (europa.eu)  
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).  
EUR-Lex - 02017R0746 -20170505 - EN - EUR-Lex (europa.eu)  G/TBT/N/EU/1044  
 
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  9. Proposed date of adoption:  April 2024 (as early as possible)  
Proposed date of entry into force:  On the day of its publication in the Official Journal 
of the European Union  
10. Final date for comments:  20 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
EUR-Lex - 52024PC0043 - EN - EUR-Lex (europa.eu)  
https://members.wto.org/crnattachments/2024/TBT/EEC/24_00907_00_e.pdf