关于医疗器械并修订指令2001/83/EC、条例(EC) No 178/2002和条例(EC) No 1223/2009 (COM(2012) 542)的欧洲议会和理事会条例提案 
NOTIFICATION
 
The following notification is being circulated in accordance with Article 10.6
 

1、Notifying Member:  European Union 
If applicable, name of local government involved (Article 3.2 and 7.2):  

2、Agency responsible:  European Commissionvu
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 regulatory framework for medical devices. 
The scope of the EU legislation will be clarified and extended (e.g. implants for aesthetic purposes; products manufactured utilising non-viable human tissues or cells).   
Supervision of the independent conformity assessment 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 are streamlined and the position and powers of notified bodies vis-à-vis the manufacturers will be enhanced ensuring thorough tests and regular checks, including unannounced factory inspections. 
Economic operators (e.g. manufacturers, importers, distributors) will be subject to clearer obligations and responsibilities, including those in the field of diagnostic services and internet sales.
The European database on medical devices (Eudamed) 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 Identification (UDI) system to allow traceability of medical devices. 
Rules concerning clinical investigations on medical devices and the required clinical data for the pre-market and the continuous post-market assessment of medical devices will be reinforced. 
The classification rules that divide the broad scope of medical devices into four different risk classes as well as the essential health and safety requirements, including labelling provisions, are adapted to technological and scientific progress.   
Coordination between national competent authorities 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 converging the regulatory requirements for medical devices in major economies.
The proposal, after being adopted, will replace the existing medical devices directives, i.e. Council Directive 90/385/EEC and Council Directive 93/42/EEC.
Another proposal has been adopted for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices which is subject to a separate notification.

7、Objective and rationale, including the nature 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 June 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