. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/EEC/112 
28 June 2006 
 (06-3133) 
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@cec.eu.int 
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):   Medical Devices 
5. Title, number of pages and language(s) of the notified document:   COM(2005) 681 
final, Proposal for a Directive of the Europ ean Parliament and of the Council amending 
Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives. 
(41 pages; English, French, Spanish) 
6. Description of content:   This proposal amends Directive 93/42/EEC on medical devices by 
modifying current provisions, to bring about clarity and by introducing certain new 
provisions, seen as necessary to continue to  ensure a high level of protection of human 
health.   The proposal also increases transpar ency and provides a legal basis for planned 
initiatives, such as improved cooperation betw een Member States and enhanced cooperation 
at an international level. 
Moreover, the proposal updates Directive 90/385/EEC on active implantable medical 
devices to make it coherent with the other Dir ectives on medical devices.  Finally, Directive 
98/8/EC on biocides is amended to exclude in vitro diagnostic medical devices from its scope. 
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Review and update of existing legislation in th e light of experience in order to improve the 
functioning of the Internal Market while ensuring a high level of protection of human health in an area characterised by fast technical progress. G/TBT/N/EEC/112 
Page 2  
 
  More precisely, the proposal’s main aims ar e: simplification, legal certainty, better 
implementation, transparency to the public , better assessment of conformity and better 
coordination and communication of market surveillance activities, including at an 
international level. 
8. Relevant documents:   COM(2005) 681 final, Proposal for a Directive of the European 
Parliament and of the Council amending C ouncil Directives 90/385/EEC and 93/42/EEC 
and Directive 98/8/EC of the European Parliame nt and the Council as regards the review of 
the medical device directives.  
Existing legislation that is being reviewed:  
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 
(OJ L 169, 12.7.1993, p. 1) 
Council Directive 90/385/EEC of 20 June 1990  on the approximation of the laws of the 
Member States relating to active implantabl e medical devices (OJ L 189 , 20.07.1990, p. 
0017)  
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 
concerning the placing of biocidal products on the market (OJ L 123, 24.04.1998, p. 0001). 
9. Proposed date of adoption:   
Proposed date of entry into force:    End 2006 
Entry into force foreseen 20 days after 
publication, the provisions are foreseen to 
become applicable in the Member States 24 
months following entry into force. 
10. Final date for comments:   90 days after 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 80 43 
E-mail:  ec-tbt@cec.eu.int 0032