Medical Devices product certification

 

BSI has a new website dedicated to medical devices.

As a Notified Body under the Medical Devices Directives, BSI has one of the broadest scopes of any Notified Body.  

  • The Medical Devices Directive (MDD) - all products
  • The Active Implantable Medical Devices Directive (AIMDD) - all products
  • The In Vitro Diagnostics Directive (IVDD)
  • This means whatever type of device a manufacturer wishes to market in Europe, where CE marking is now a legal requirement, BSI has the technical expertise to assist and provide appropriate conformity assessment services.