  
  
G/TBT/N/EU/873  
11 February 2022  
(22-1300) 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/tb t/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 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  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Implementing Regulation laying down common specifications for certain 
class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 
of the European Parliament and of the Council (5 page(s), in English; 63 page(s), in 
English)  
6. Description of content:  This draft Commission Implementing Regulation provides 
common specifications for some high -risk in vitro  diagnostic medical devices in 
accordance with Art. 9 of Regulation (EU) 2017/746, notably in relation to their 
performance evaluation.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this Implementing Re gulation is to set uniform requirements 
for the devices in an area where no harmonised standards exist or where they are not 
sufficient, and where there is a need to address public health concerns. The common 
specifications (CS) provide a presumption of co nformity with the corresponding legal 
requirements of Regulation (EU) 2017/746. Therefore they will greatly facilitate the work 
of manufacturers in complying with the legislation, the assessment by the notified bodies, 
testing by EU reference laboratories and oversight by the national competent authorities. 
Moreover, they will facilitate an aligned approach to conformity assessment of these 
devices across the Union and the achievement of consistently high standards of device 
performance. They will contribut e to ensuring a high level of public health and patient 
safety as well as an equal level playing field for all industry actors and a better functioning 
of the EU's internal market. The adoption of the CS is one of the high priority actions 
identified in th e Joint Implementation and Preparedness Plan for Regulation (EU) 
2017/746 .As soon as the CS will be available, notified bodies will not be obliged to s ubmit G/TBT/N/EU/873  
 
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  the manufacturer's performance evaluation report for class D devices covered by the CS 
to the expert panel in accordance with Article 48(6) of Regulation (EU) 2017/746. The CS 
will also facilitate the preparation of technical documentation by the man ufacturers and 
speed up its assessment by the notified bodies. This act will therefore accelerate 
conformity assessment procedures and thereby free up notified body capacities. As this 
is the main challenge related to the implementation of Regulation (EU) 2017/746, the CS 
should be adopted as soon as possible, justifying a reduced commenting period.; 
Protection of human health or safety; 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 - 32017R0746 - EN - EUR-Lex (europa.eu)  
9. Proposed date of adoption:  March 2022 (as soon as possible)  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU. There is a transition period of 2 years following entry into force of the regulation.  
10. Final date for comments:  30 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://members.wto.org/crnattachments/2022/TBT/EEC/22_ 1569_00_e.pdf  
https://members.wto.org/crnattachments/2022/TBT/EEC/22_1569_01_e.pdf  
 