. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/227 
21 October 2008 
 (08-5089) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   EUROPEAN COMMUNITIES
 
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, e-mail and web-site 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be  indicated if different from above:    
European Commission 
EC-TBT Enquiry Point Fax:  +(32) 2 299 80 43 E-mail:  ec-tbt@ec.europa.eu
 
Website: http://ec.europa.eu/enterprise/tbt/  
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 as defined in Directive 98/79 /EC on in vitro diagnostic medical devices 
5. Title, number of pages and language(s) of the notified document:   Draft Commission 
Decision amending Commission Decision 2002/364/EC on common technical 
specifications for in vitro diagnostic medical devices (19 pages, in English). 
6. Description of content:    
Correction and updating of a number of scientific and technical references. 
- Refinement of the definition of ‘Rapid t est’ and inclusion of the definitions of  
‘Robustness’, ‘Whole system failure rate’, ‘C onfirmation assay’, ‘Virus typing assay’,  
‘Sero-conversion HIV samples’ and ‘E arly sero-conversion HIV samples’; 
- Clarification of the requirements for HIV screening assays; 
- Addition of requirements for HIV antibody/antigen combined tests; 
- Further specification of the sample requirements for certain assays, such as HCV.  
7. Objective and rationale, including the nature of urgent problems where applicable:    
1. Adoption of Commission Decision 2002/364/EC on common technical specifications for 
in vitro diagnostic medical devices to technical progress; 2. Insertion on this occasion of corrections, clarifications and refinements; 3. Protection of human health. G/TBT/N/EEC/227 
Page 2  
 
  8. Relevant documents:    
Directive 98/79/EC on in vitro diagnostic medi cal devices; OJ L 331, 7.12.1998, p. 1-37 
(http://eur-lex.europa.eu/LexUriServ/Lex UriServ.do?uri=CELEX:31998L0079:EN:HTML
) 
Commission Decision 2002/364/EC on common technical specifications for in vitro 
diagnostic medical devices; OJ L 131, 16.5.2002, p. 17-30
(http://eur-lex.europa.eu/LexUriServ/Lex UriServ.do?uri=CELEX:32002D0364:EN:HTML ) 
9. Proposed date of adoption:   
Proposed date of entry into force:    End of 2008 
Applicable from 1 December 2009 
10. Final date for comments:   60 days from date of notification. 
11. Texts available from:  National enquiry point [    ] or address, telephone and fax 
numbers, e-mail and web-site addresses, if available of the other body:   
European Commission 
EC-TBT Enquiry Point Fax:  + (32) 2 299 8043 E-mail:  ec-tbt@ec.europa.eu
 
The text is available on the EC-TBT Website :  http://ec.europa.eu/enterprise/tbt/    
And at: 
http://members.wto.org/crnattachments/2008/tbt/eec/08_3326_00_e.pdf