EUDAMED Information Centre - PROD

Actors and definitions

Infographic.png The image opens an infographic illustrating the process.

Click to open infographic.jpg


Actors involved in EUDAMED are:

Supervising bodies

  • European commission

  • Competent authorities (CAs), including designating authorities

  • Notified bodies (NBs)

Economic operators

  • Manufacturers - see Article 2(30) or Article 2(30) of Regulation 2017/745

  • System and procedure pack producers – any individual or organisation who places procedure packs and/or systems on the EU market

  • Authorised representatives – see Article 2(32) of Regulation 2017/745

  • Importers – see Article 2(33) of Regulation 2017/745