Downloads - EU Medical Devices Directives

 

  
 Medical Devices and CE marking
Introduction
EU Medical Devices Directive
        Guide to Implementation
        Downloads - EU Directives Medical
        Downloads & Links
ISO 13485/ EN 46001 - QMS for Medical Directives
In Vitro Diagnostics Directive
   

 
Get a copy of the Medical Devices Directive 93/42/EEC here ( Adobe PDF Format)
Get a copy of the In-Vitro Diagnostics Directive 98/79/EEC here ( Adobe PDF Format)
Download your 'CE' Marking graphic here

The full text of all community Directives and copies of the Official Journal of the European Communities are available from:

COUNTRY

SUPPLIER

ADDRESS
United Kingdom HMSO Books (Agency section) HMSO Publications Centre 51 Nine Elms Lane London SW8 5DR Tel: +44 (0)171 873 9090 Fax: +44 (0)171 873 8463
United States of America/ Canada UNIPUB 4611-F Assembly Drive Lanham MD 20706-4391 Tel: 800 274 4888 Fax: 301 459 0056
Others Office for Official Publications of the European Communities 2, Rue Mercier 2985 Luxembourg Tel: 49 928-1 FAX: 48 85 73/48 68 17

Visit the website of the European Community on http://europa.eu.int/comm/enterprise/newapproach/index.htm for more information on the New Approach to technical harmonisation and the Global Approach to conformity assessment.


  
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