Guidance from the European Commission on medical devices

Updated 12 January 2016

In collaboration with the national competent authorities in Europe and other stakeholders, the European Commission prepares a number of guidelines and other interpretative documents on the medical devices regulations.

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 prepared by the European Commission together with member states, the industry and other stakeholders.

The topics included are:

  • Borderline and classification

  • Clinical investigation and evaluation

  • European Medical Device Nomenclature (EMDN)

  • Importers and Distributors

  • New technologies

  • Notified Bodies

  • Unique Device Identifier (UDI)

  • Legacy devices

  • Classification of MD and IVD

  • Transitional period

  • IVDs (In vitro diagnostic medical devices)

Commission decisions and recommendations