Skip to main content

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 your country of business.

** 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 your AR.

EUDAMED Non-EU manufacturer registration request

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

Anyone with an EU Login account can register actor details in EUDAMED (if the actor is not already registered). Once completed, the registration form can be submitted directly for validation or saved as a draft.

By default, this user will become the Local Actor Administrator once the registration is validated.

Note

Multiple roles

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