WORLD TRADE  
ORGANIZATION   
G/TBT/N/EU/71 
23 October 2012  
 (12-5777) 
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):  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 medical devices, and amending 
Directive 2001/83/EC, Regulation (EC) No  178/2002 and Regulation (EC) No 1223/2009 
(COM(2012) 542) (194 pages, in English, 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 medical devices aims at revising the EU re gulatory framework for medical 
devices.  
The scope of the EU legislation will be clarif ied and extended (e.g. implants for aesthetic 
purposes; products manufactur ed utilising non-viable human tissues or cells).    
Supervision of the independent conformity asse ssment bodies (so called 'notified bodies') by 
the Member States will be strengthened to ensure that all bodies have the necessary competence to carry out the pre-market assessment of medical devices.   
The conformity assessment procedures ar e streamlined and the position and powers of 
notified bodies vis-à-vis the ma nufacturers will be enhanced  ensuring thorough tests and 
regular checks, including una nnounced factory inspections.  
Economic operators (e.g. manufactu rers, importers, dist ributors) will be subject to clearer 
obligations and responsibilities, including those in the field of diagnostic services and internet 
sales. G/TBT/N/EU/71 
Page 2  
 
  The European database on medical devices (E udamed) will be further developed to provide 
comprehensive information regarding medical devices on the EU market. Non-confidential 
data will be publicly available.  
The proposal sets the basis for a European Unique Device Id entification (UDI) system to 
allow traceability of medical devices.  
Rules concerning clinical investigations on medica l devices and the required clinical data for 
the pre-market and the continuous post-mar ket assessment of medical devices will be 
reinforced.  
The classification rules that divi de the broad scope of medical de vices into four different risk 
classes as well as the essentia l health and safety requirements , including labelling provisions, 
are adapted to technological a nd scientific progress.    
Coordination between national competent authorit ies will be improved, in particular in the 
field of market surveillance, with the European Commission providing the necessary 
scientific, technical and administrative support.  
Relevant guidelines developed by the Global  Harmonization Task Force (GHTF) will be 
incorporated into EU law with a view to c onverging the regulatory re quirements for medical 
devices in major economies. 
The proposal, after being adopted, will replace the existing medical devi ces directives, i.e. 
Council Directive 90/385/EEC and Council Directive 93/42/EEC. 
Another proposal has been adopted for a Regula tion of the European Parliament and of the 
Council on in vitro diagnostic medical devices which is s ubject to a separate notification.   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety  
8. Relevant documents:   Council Directive 90/385/EEC of 20 June 1990 on the approximation 
of the laws of the Member States relating to active implantable medical devices  
"http://eur-
lex.europa.eu/LexUriServ /LexUriServ.do?uri=CONSLEG:1990L0385:20071011:en:PDF "  
Council Directive 93/42/EEC of 14 Ju ne 1993 concerning medical devices  
"http://eur-
lex.europa.eu/LexUriServ /LexUriServ.do?uri=CONSLEG:1993L0042:20071011: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 3 years after entry into force (except for the 
provisions regarding the designation of notified 
bodies).  G/TBT/N/EU/71 
 Page 3 
 
 
   
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:2012:0542:FIN:EN:PDF    
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2012:0542:FIN:FR:PDF  
http://eur-lex.europa.eu/LexUriServ/L exUriServ.do?uri=COM:2012:0542:FIN:ES:PDF  
http://members.wto.org/crnatt achments/2012/tbt/EEC/12_4145_00_e.pdf