WELCOME SERVICES DOCUMENTS ASSOCIATES CONTACT US
      
EU Directives



EU Guidelines MEDDEV



EU Guidelines Notified Body Recommendation



Software Validation Guide





   

EU Directives

Background
 
Within the EC there are three different directives within the field of medical devices.  
The purpose of the directives is to secure a certain equal quality level through out Europe. The EC directives are transposed to Danish legislation through statutory orders from the Danish "Ministry of the Interior and Health".
 
Medical Devices Directive (MDD)
 
Under the MDD a "medical device" is defined as any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • investigation, replacement or modification of the anatomy or of a physiological process,
  • control of conception,

and which does not achieve its principal intended action in or on the humna body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

 
Invitro Diagnostic Medical Devices Directive (IVDD)
 
 
Active Implatable Medical Devices Directive (AIMDD)