Medical Devices - CE marking and EU Directives

What is the Directive?

Under the Medical Devices Directives, we have 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.



What products do we test?

The Directive 

covers an extremely wide range of products, including, for example:

  • first aid bandages
  • tongue depressors
  • hip prostheses
  • X-ray equipment
  • ECG
  • heart valves
  • spectacles



Next steps

Contact us today to start your journey to certification where we can help you to meet the requirements of the Directive.