G/TBT/N/EU/46 8 
 
31 March 2017  
(17-1773) 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/  
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, n umber of pages  and language(s)  of the notified document:  Draft Commission 
Decision amending Decision 2002/364/EC as regards requirements for HCV 
antigen/antibody combined tests and Nucleic Acid Amplification techniques in qualitative 
HIV assays (3 pages + Annex 2 pages, in English)  
6. Description of content:  This draft decision updates the common technical specifications, 
set out in article 5.3 of the Directive 98/79/EC on in vitro  diagnostic medical devices, for 
some in vitro  diagnostic medical devices ac cording to the state of the art, notably 
regarding HCV antibody/antigen combined tests and Nucleic Acid Amplification techniques 
("NAT") assays for HIV.  
7. Objective and rationale , including the nature of urgent problems where applicable: 
The objective of  this decision is to improve the level of safety of some in vitro  diagnostic 
medical devices put on the EU market: specifically hepatitis C virus (HCV) 
antibody/antigen combined tests and nucleic acid amplification technique (NAT) for HIV 
assays.  
It will r einforce 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): 
http://eur-lex.europa.eu/legal -
content/EN/TXT/?qid=1484579511153&uri=CELEX:02002D0364 -20120701  G/TBT/N/EU/468  
 
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  9. Proposed date of adoption: 4th quarter 2017  
Proposed date of entry into force: 20 days from publication in the Official Journal of the 
EU. There is a transition period of 6 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 
number s and e mail and website address es, if availab le, 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 Website: http://ec.europa.eu/growth/tools -databases/tbt/  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_1593_00_e.pdf  
https://members.wto.org/crnattachments/2017/TBT/EEC/17_1593_01_e.pdf