Medical Devices CE marking EU instructions
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 (MDD) - all products
- The Active Implantable Medical Devices Instruction (AIMDD) - all products
- The In Vitro Diagnostics Instruction (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 compliance assessment services.
