G/TBT/N/EU/468/Rev.1  
 
16 October 2018  
(18-6425) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  
NOTIFICATION  
Revision  
The following notification is being circulated in accordance with Article 10.6.  
 
1. Notifying Member: EUROPEAN UNION  
If applicable, name of local government involved (Articles 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, number of pages and language(s) of the notified document: Draft 
Commission Implementing Decision amending Decision  2002/364/EC as regards 
requirements for HIV and HCV antigen and antibody combined tests and as regards 
requirements for nucleic acid amplification techniques with respect to reference materials 
and qualitative HIV assays (and its accompanying annex) (3 pa ges + Annex 4 pages, in 
English)  
6. Description of content: This draft decision updates the common technical specifications, 
provided for in article 5.3 of the Directive 98/79/EC on in vitro  diagnostic medical devices, 
for some in vitro  diagnostic medical  devices according to the state of the art, notably 
regarding HCV antibody and antigen combined tests and nucleic acid amplification 
techniques ("NAT") assays for HIV. It differs from the draft decision notified under 
G/TBT/N/EU/468 in that it covers bette r combined tests, in particular for HCV.  
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 marke t: specifically hepatitis C virus (HCV) 
antibody and antigen combined tests and nucleic acid amplification technique (NAT) for 
HIV 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.  G/TBT/N/EU/468/Rev.1  
 
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  8. Relevant documents:  
• Decision 2002/364/EC on common technical specifications for in vitro  diagnostic 
medical devic es (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 ,  
9. Proposed date of adoption:  1st quarter 2019  
Proposed date of entry into force:  20 days from publication in the Official Journal of 
the EU. There is a transitional 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 or 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/   
https://members.wto.org/crnattachments/2018/TBT/EEC/18_5420_00_e.pdf  
https://members.wto.org/crnattachments/2018/TBT/EEC/18_5420_01_e.pdf