Commission guidance on medical devices
In conjunction with the national competent authorities and other stakeholders, the European Commission prepares a number of guidelines and other interpretative documents on medical devices.
The documents are not legally binding, but in practice the authorities expect that they are complied with.
Here you can find a number of guidance documents on medical devices drafted by the European Commission in conjunction with member states, industry and other stakeholders.
The following topics are covered:
- Scope, field of application, definition
- Essential requirements
- Classification of medical devices
- Conformity assessment procedure
- Clinical investigation, clinical evaluation
- Notified Bodies
- Products using materials of biological origin
- Market surveillance
- Device Specific Vigilance Guidance
- Transitional period