G/TBT/N/EU/845  
18 October 2021  
(21-7859) Page: 1/2 
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/e n/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  In vitro 
diagnostic medical devices; Medical equipment (ICS 11.040), In vitro diagnostic test 
systems (ICS 11.100.10)  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Coun cil amending Regulation (EU) 
2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices 
and deferred application of requirements for in -house devices (13 page(s), in English)  
6. Description of content:  Regulation (EU) 2017 /746 on in vitro diagnostics medical 
devices (IVD Regulation) will apply from 26 May 2022. It establishes a new regulatory 
framework for in vitro  diagnostic medical devices including conformity assessment 
procedures. It was notified to the WTO as notificat ion G/TBT/N/EU/72 . 
Due to the additional resources required to address the COVID -19 pandemic, it is now 
clear that national authorities, health institutions, notified bodies and economic operators 
will not be in a position to ensure the proper implementation and application of the 
Regulation from the date of application.  
With only six notified bodies designated so far, there is a grave shortage of notified body 
capacity, making it impossible for manufacturers to conduct the legally required 
conformity assessment procedures in time. In addition, due to COVID -19 travel 
restrictions, notified bodies were not able to carry out the required on -site audits at the 
manufacturers' premises to verify the manufacturing and other relevant processes. This 
risks significant disruption in the supply of a multitude of in vitro  diagnostic m edical 
devices (e.g. HIV tests, pregnancy tests or SARS -CoV-2 tests) on the European Union 
market.  
The draft measure proposes a staggered set of transition periods for devices that are 
required to undergo conformity assessment procedures involving a notif ied body. The G/TBT/N/EU/845  
 
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  length of the transition periods depends on the risk class of the devices, with shorter 
transition periods for higher risk devices and longer periods for lower risk ones. In 
addition, the notified draft proposes a deferred application of the requirements for 'in -
house devices', i.e. those made and used within the same health institution.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The draft measure maintains the objectives of Regulation (EU) 2017/746 to 
ensure a high level of safety and performance of devices by enhancing their oversight by 
notified bodies and, in the case of in -house devices, by setting uniform requirements on 
health institutions. It only provides for the necessary additional time to achieve this 
objective whilst ensuring theprotection of human health and safety, in particular to 
prevent shortage of essential IVD devices. Having regard to the usual length of conformity 
assessment procedures, the amendment to Regulation 2017/746 needs t o 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 Regulation (EU) 2017/746 will become 
applicable. Therefore, given that this notified draft on ly amends the previously 
notified   measure (Regulation (EU) 2017/746) by extending its transitional 
provisions'scope and timelines, a reduced commenting period is justified.; Other  
8. Relevant documents:   
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)  
9. Proposed date of adoption:  October/November 2021 (as early as possible)  
Proposed date of entry into for ce: On the day of its publication in the Official Journal 
of the European Union  
10. Final date for comments:  10 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/  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=COM%3A2021%3A627%3AFIN&qid=1634295896548  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_6588_00_e.pdf