AMTAC Certification Services
   
 

Implementing the EU Medical Devices Directive 93/42/EEC

Stage 1: Obtain a Copy of the Directive


The Medical Devices Directive (93/42/EEC) is detailed in the Official Journal of the European Communities reference L169 and may be obtained 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
  USA/ 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
 
  Implementing the
  EU Medical Devices Directive 93/42/EEC
 Medical Devices and CE marking
 1: Obtain a Copy of the Directive
 2: Does the Directive apply to you?
3: What risk 'Classification' is your
 4: Which 'Conformity routes' are available
 5: Choose your Notified Body
 6: Implement your conformity route
 7: The 'Essential Requirements'
 8: Documentation
 9: Product labelling and instructions
10: Arrange your Notified Body Audit
11: Apply the 'CE' Marking on your devices


Download a copy of 93/42/EEC HERE