AMTAC Certification Services
   
 

Implementing the EU Medical Devices Directive 93/42/EEC

Stage 11: Apply the 'CE' Marking on your devices and enjoy free access to the European Market.

Download your CE graphic here

Detailed guidelines and extracts of the European Notified Bodies Group recommendations are available to contracted clients, on request

  
  Implementing the
  EU Medical Devices Directive 93/42/EEC
 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