Medical Devices product certification

 

BSI has a new website dedicated to medical devices

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

  • The Medical Devices Instruction (MDI) - all products
  • The Active Implantable Medical Devices Instruction (AIMDI) - all products
  • The In Vitro Diagnostics Instruction (IVDI)
  • 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 compliance assessment services.