Medical Devices - New regulations

Guidance

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.

These are legally non-binding guidance documents, whose main purpose is ensuring uniformity in the application of the regulations

Click the below button to consult all guidance documents

The Medical Devices Coordination Group (MDCG) has endorsed documents on the following subjects:

  • UDI
  • EUDAMED
  • European Medical Device Nomenclature
  • Notified bodies Clinical Investigation and Evaluation
  • New Technologies
  • Other topics
  • Other Guidance documents