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?
covers an extremely wide range of products, including, for example:
- first aid bandages
- tongue depressors
- hip prostheses
- X-ray equipment
- heart valves
Contact us today to start your journey to certification where we can help you to meet the requirements of the Directive.