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Introduction

Economic Operator means one of the following:

  • Manufacturer (MF: EU Manufacturers* & Non-EU Manufacturers**)

  • Authorised Representative (AR)

  • System/Procedure Pack Producer (SPPP)

  • Importer (IM)

* EU manufacturers: If you are established in the EU, your registration will be assessed by the Competent Authority (CA) of the country where you are established.

** Non-EU manufacturers: If you are not established in the EU, your registration will be verified by the Authorised Representative you indicate in your actor registration request, before being assessed by the Competent Authority responsible for that AR.

EUDAMED Non-EU manufacturer registration request

The difference in registration process between the two types of MFis highlighted in the Manage section.

Note

Multiple roles

If your organisation has more than one Actor role (i.e. your organisation is a manufacturer and an importer at the same time), you must make separate actor registrations for each.