G/TBT/N/EU/943  
9 January 2023  
(23-0249) 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 addition, 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 the transitional provisions for certain medical 
devices and in vitro diagnostic medical devices (COM(2023) 10 final); (15 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 object ives are a high level of protection of health for patients and users 
and the smooth functioning of the internal market for these products.  
The MD Regulation has been applicable since 26 May 2021; it provides for a transition 
period that will end on 26 May 2024. It was notified to the WTO as notification 
G/TBT/N/EU/71.  
The IVD Regulation 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 . 
Despite considerable progress over the past years, the capacit ies of conformity 
assessment ('notified') bodies remain insufficient and manufacturers are not sufficiently 
prepared to meet the strengthened requirements of the MD Regulation on time. This is G/TBT/N/EU/943  
 
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  threatening the availability of medical devices on the EU marke t. The situation is 
exacerbated by the impact of the COVID -19 pandemic on clinical investigations, on -site 
audits and global supply chains.  
This proposal aims to extend the current transition period laid down in Article 120 of the 
MD Regulation, based on c ertain 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 MDR, if those conditions are fulfilled. The draft measure proposes a staggered 
extension of the transition period depending on the risk class of the device, i.e. until 2027 
for devices with a higher risk and until 2028 for medium and lower risk devices. The 
extension of the transition period is complemented by an extension of the validity of 
certificates issued under the previous Council Directives 90/385/EEC and 93/42/EEC for 
the device s benefiting from the extended transition period. Also the validity of certificates 
that have already expired since 26 May 2021 would be extended.  
It also proposes to remove the provisions in the MD Regulation and in the IVD Regulation 
on the 'sell -off' da te, i.e. the end date for the further making available of devices which 
are placed on the market before or during the transition period and which are still in the 
supply chain when the transition period is over. This would prevent unnecessary disposal 
of safe medical devices, which are already on the market but not yet with the final user.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The draft measure maintains the objectives of Regulations (EU) 2017/745 
and (EU) 20 17/746 to ensure a high level of safety and performance of devices by 
enhancing their oversight by notified bodies.  
It only provides for the necessary additional time to achieve this objective whilst ensuring 
the protection of human health and safety, in p articular to prevent shortages of medical 
devices.  
Having regard to the usual length of conformity assessment procedures, the amendment 
to Regulation 2017/745 needs to be adopted as quickly as possible in order to ensure 
legal certainty for all actors, inc luding manufacturers and notified bodies, ahead of the 
date on which the current transition period will end (26 May 2024).  
Therefore, given that this notified draft only amends the previously notified measures 
(Regulation (EU) 2017/745 and Regulation (EU) 2017/746) by extending its transitional 
provisions' scope and timelines, a reduced commenting period is justified; 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  diagno stic 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)  
9. Proposed date of adoption:  February/March 2023 (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:  10 days from notification  G/TBT/N/EU/943  
 
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  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/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_0277_00_e.pdf