The past 7 months were certainly challenging as we endeavored to write procedures, train out employees and implement our 9001 system, however, this task would have been impossible were it not for your supervision, your guideance and your sense of humour. Words alone cannot convey our true sense of appreciation. We wish you continued success in your ISO consulting business and we will heartily recommend your firm to anyone who approaches us seeking such services.-TP Composites

Personal tools
You are here: Home → Information on International Standards → Medical Devices
 

Medical Devices

MDD CE Marking

THE MEDICAL DEVICES DIRECTIVE


Since 14 June 1998 it has no longer been permitted for medical devices to be offered for sale in Europe without CE marking. For many products CE marking may only be affixed with proof of a certified quality system and/or product testing. Quality Systems must be certified by a Notified Body.

Scope


A Medical device, that is any instrument, apparatus, appliance, material or other article, including the software necessary for its proper operation, used for human beings for any of the following purposes:

Diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap or compensation for injury or handicap, Investigation, replacement or modification of the anatomy or of a physiological process. Control of conception.

Exclusions

 

  • In Vitro Diagnostic Medical Devices
  • Active Implantable Medical Devices (Covered by Directive 90/385/EEC)
  • Cosmetics (Covered by Directive 76/68/EEC)
  • Medicines (covered by Directive 65/65/EEC)

CLASSIFICATION OF DEVICES

 

Devices covered by the Directive are grouped into four classes as follows:

Class I - generally regarded as low risk
Class IIa - generally regarded as medium to low risk
Class IIb - generally regarded as medium to high risk
Class III - generally regarded as high risk

 

 

 

 

 

 
 
 

 

Document Actions