. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/EEC/381 
8 June 2011  
 (11-2824) 
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:  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 [   ], 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):  Certain medical devices 
5. Title, number of pages and language(s) of the notified document:  Draft Commission 
Regulation on electronic instructions for use of medical devices (9 pages, in English) 
6. Description of content:  The draft Regulation sets out conditions according to which 
instructions for use in paper form  may be replaced by electronic inst ructions for use.  It limits 
the possibility of providing instructions for us e in electronic form to defined medical devices 
and accessories intended to be used in specific  conditions. Furthermore, it contains a range of 
procedural safeguards.  Thus instructions for use have to be provided in paper form on 
request, and a specific risk assessment by the manufacturer a nd information on how to access 
to the instructions for use is needed.  
The draft Regulation also sets up a fe w basic safety requirements for: 
- instructions for use in electronic form which are provided in addition to complete 
instructions for use in paper form, and  
- websites containing such instructions for use.  G/TBT/N/EEC/381 
Page 2  
 
  7. Objective and rationale, including the nature of urgent problems where applicable:  For 
some medical devices the provision of instructi ons for use in electronic form instead of in 
paper form can be beneficial for professional users.  It ca n reduce the environmental burden 
and improve the competitiveness of the medical  devices industry by reducing costs, while 
maintaining or improving the level of safety.  
8. Relevant documents:    
Council Directive 90/385/EEC  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=CELEX:31990L0385:EN:HTML   
and Directive 93/42/EEC 
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=CELEX:31993L0042:EN:HTML    
9. Proposed date of adoption:   
Proposed date of entry into force:   14 December 2011.  Date of application: one 
year later. 
10. Final date for comments:  60 days from date of notification 
11. Text available from: National enquiry point [  ], or addre ss, 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:  eu-tbt@ec.europa.eu  
The text is available on the EU-TBT Website:  http://ec.europa.eu/enterprise/tbt/