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EUDAMED Actors

Infographic.png INFOGRAPHIC: Actor ID/SRN and Actor roles

EUDAMED Actor roles infographic

Actors

Actors involved in EUDAMED are:

Supervising bodies

  • European Commission

  • Competent Authorities (CA)

  • Designating Authorities (DA)

  • Notified Bodies (NB).

Economic operators

  • Manufacturers

  • System and procedure pack producers

  • Authorised Representatives

  • Importers

Sponsors

  • Sponsors of clinical investigations/performance studies.

EUDAMED access is based on three levels

EUDAMED access is personal and given to each individual user based on three levels:

  • Actor - your organisation (in a certain Actor role)

  • User - you as an individual

  • Profile - the tasks you are allowed to do (per module)