G/TBT/N/EU/978  
11 May 2023  
(23-3312) 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 CC CN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Products 
without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 on 
medical devices.  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation amending Implementing Regulation (EU) 
2022/2346 as regards the transitional provisions for certain products without an intended 
medical purpose listed in Annex XVI to Regula tion (EU) 2017/745 of the European 
Parliament and of the Council; (5 page(s), in English)  
6. Description of content:  the draft measure amends the transitional provisions 
established in Commission Implementing Regulation (EU) 2022/2346 (notified under 
G/TBT/N/EU/866). All the periods are extended and for Annex XVI products covered by a 
certificate issued by a notified body in accordance with Directive 93/42/EEC, the 
conditions to benefit from the amended transitional provisions are aligned to those 
establis hed by Regulation (EU) 2017/745, as amended by Regulation (EU) 2023/607 
(notified under G/TBT/N/EU/943).  
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
Commission Implementing Regulation (EU) 2022/2346 lays down common specifications 
for the risk management of products without an intended medical purpose that are listed 
in the Annex XVI to Regulation (EU) 2017/745. These common specifications entered into 
force on 22 December 2022 and will be applicable from 22 Ju ne 2023.  G/TBT/N/EU/978  
 
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  Regulation (EU) 2023/607 of the European Parliament and of the Council amended 
Regulation (EU) 2017/745 extending the duration of the transitional periods and adding 
conditions to be fulfilled to benefit from those transitional periods. The end of  the 
transitional periods has been moved from 26 May 2024 to 31 December 2027 or 31 
December 2028, depending on the risk class of the device. Such extension aims at 
reducing the risk of shortages of devices covered by certificates issued under the previous  
Directive 90/385/EEC or Directive 93/42/EEC and allows notified bodies to build up 
sufficient capacity to carry out the conformity assessment procedures.  
Transitional provisions established in Commission Implementing Regulation (EU) 
2022/2346 for Annex XV I products covered by a certificate issued by a notified body in 
accordance with Directive 93/42/EEC need to be consistent and aligned to those newly 
established in the amended Regulation (EU) 2017/745.  
In addition, transitional provisions for Annex XVI pr oducts for which clinical investigations 
are performed or for which a notified body must be involved in the conformity assessment 
procedure need to be extended to reduce as much as possible the overlapping with 
conformity assessments of medical devices, an d to avoid increasing the risk of shortages 
of medical devices.  
Regulation (EU) 2023/607 has been adopted in view of the exceptional circumstances 
arising from an imminent risk of shortages of medical devices and the associated risk of 
a public health cris is. To avoid such risks, also the notified document should be adopted 
as soon as possible and possibly before the date of application of the Commission 
Implementing Regulation (EU) 2022/2346, which is 22 June 2023.  
A 30 days period for comments is set cons idering those risks and that the notified 
document only extends the duration of the transitional periods and aligns the conditions 
that have to be met to benefit from the amended transitional periods to those already 
established by Regulation (EU) 2023/607 . 
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 2011/83/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, 5.2017, p. 1 -175).  
http://data.europa.eu/eli/reg/2017/745/2020 -04-24 
Commission Implementing Regulation (EU) 2 022/2346  
http://data.europa.eu/eli/reg_impl/2022/2346/oj  
Regulation (EU) 2023/607 of the European Parliament and of the Council  
http:/ /data.europa.eu/eli/reg/2023/607/oj  
9. Proposed date of adoption:  2nd quarter 2023  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU  
10. Final date for comments:  30 days from notification  G/TBT/N/EU/978  
 
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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_09601_00_e.pdf