  
  
G/TBT/N/EU/673  
9 August 2019  
(19-5211) 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 Commission,  
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 [   ], 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 Decision amending Decision 2002/364/EC as regards definitions 
of first -line assays and confirmatory assays, requirements for devices for self -testing  and 
requirements for HIV and HCV rapid tests, confirmatory and supplementary assays (3 
pages + Annex 6 pages, in English)  
6. Description of content:  This draft decision updates the common technical specifications, 
provided for in article 5.3 of the Direc tive 98/79/EC on in vitro diagnostic medical devices, 
for some in vitro  diagnostic medical devices according to the state of the art, notably 
definitions of first line and confirmatory assays, requirements for self -tests and 
requirements for HIV and hepati tis C virus rapid tests and confirmatory assays.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this decision is to provide clear definitions for certain types of 
assays, namely first line and confir matory assays, and to improve the level of safety of 
some in vitro diagnostic medical devices put on the EU market, specifically self -tests and 
HIV and hepatitis C virus rapid tests and confirmatory assays. It will reinforce the control 
by notified bodies of the placing on the market of these in vitro  diagnostic medical devices, 
ensure an equal level playing field for all industry actors and a better functioning of the 
internal market . 
8. Relevant documents:   
Decision 2002/364/EC on common technical specifications for in vitro  diagnostic medical 
devices ( Official Journal L 131 , 16/05/2002 P. 0017 - 0030): G/TBT/N/EU/673  
 
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  http://eur -lex.europa.eu/legal -
conte nt/EN/TXT/?qid=1484579511153&uri=CELEX:02002D0364 -20120701  
9. Proposed date of adoption:  4th quarter 2019  
Proposed date of entry into force:  20 days from publication in the Official Journal of the 
EU. There is a transition period of 12 months following entry into force of the regulation.  
10. Final date for comments:  60 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/2019/TBT/EEC/19_4436_00_e.pdf  
https://members.wto.org/crnattachments/2019/TBT/EEC/19_4436_01_e.pdf  
 