. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EU/72 
23 October 2012  
 (12-5778) 
Committee on Technical Barriers to Trade Original:   English 
  
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6 
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local governme nt 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:  mailto:eu-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 [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:  Proposal for a 
Regulation of the European Parliament and of the Council on in vitro diagnostic medical 
devices (COM(2012) 541) (143 pages, in Englis h, French, Spanish and other official EU 
languages).     
6. Description of content:  This proposal for a Regulation of the European Parliament and of 
the Council on in vitro diagnostic medical de vices (IVDs) aims at revision of the EU 
regulatory framework for IVDs.  
This proposal needs to be seen in conjunction with another proposal that has been adopted for 
a Regulation of the European Parliament a nd of the Council on medical devices which is 
subject to a separate notification. In addition to  the issues mentioned in that notification, the 
IVD proposal clarifies the scope in respect to  genetic tests, comp anion diagnostics and 
diagnostic services offered at a distance.  
The proposal introduces rules for the classification of IVDs in four risk  classes, based on the 
relevant GHTF guidance.  
Requirements regarding clinical evidence fo r the demonstration of compliance with the 
essential safety and performance requirements are introduced.   
The proposal, after being adopt ed, will replace the existing Directive 98/79/EC on in vitro 
medical devices.  G/TBT/N/EU/72 
Page 2  
 
  7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety.  
8. Relevant documents:   Directive 98/79/EC of the European  Parliament and of the Council of 
27 October 1998 on in vitro di agnostic medical devices 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=OJ :L:1998:331:0001:0037:EN:PDF  
9. Proposed date of adoption:   
Proposed date of entry into force:    1st semester 2014 
20 days from publication in the Official Journal of the EU. The proposed date of application is 5 years after entry into force (except for the provisions regarding the designation of notified 
bodies). 
10. Final date for comments:  90 days from date of notification. 
11. Text 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 
EU-TBT Enquiry Point Fax:  + (32) 2 299 80 43 E-mail:  mailto:eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website:  http://ec.europa.eu/enterprise/tbt/    
and at 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2012:0541:FIN:EN:PDF  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2012:0541:FIN:FR:PDF  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2012:0541:FIN:ES:PDF  
http://members.wto.org/crnatt achments/2012/tbt/EEC/12_4146_00_e.pdf