EUDAMED Information Centre - PROD

User rights and profiles

Each user may have multiple accounts but can access EUDAMED with only one account at a time.

Each EUDAMED account is associated with one of the following actors:

  • Manufacturer

  • Authorised Representative

  • System/Procedure Pack Producer

  • Importer

Each of these actors has a set of roles that are specific to each module in EUDAMED. The actions and rights connected to each role are defined by the user profile of that user (i.e. Viewer, Verifier, Linker, LAA etc) so user profiles are module specific.

Your user profile is determined by your actor (see table). For example, in ‘Actors module’, the Verifier profile is only enabled for 'Authorised Representative' actors. The Linker profile is a specific profile which is enabled only for 'Importer' actors, which allows them to create links with non-EU manufacturers in this module.

Table 1. User profiles in the actor module

User profile

Actor

Rights

Viewer

All

May only view registered actors and own actor details

Verifier

Authorised representative

View + verify non-EU manufacturer registration requests and verify/terminate associated mandates

Mandate manager

Non-EU manufacturer

View + submit / manage mandates with authorised representative(s)

Linker

Importer

View + link importer with non-EU manufacturer(s)

Local User Administrator (LUA)

All

Verify / manage mandates/ link (depending on actor role) + manage users and user access requests

Local Actor Administrator (LAA)

All

LUA + manage actor data and notification email addresses



Hierarchy of user profiles

Profiles are hierarchical, i.e. higher-level profiles contain all lower-level grants/rights.

– e.g. LAA is the highest profile and contains the rights of all the profiles beneath it in the hierarchy.

Table 2. User profiles per actor and their hierarchy

Authorised representative

Manufacturer

System and procedure pack producer

Importer

LAA

LAA

LAA

LAA

LUA

LUA

LUA

LUA

Verifier

Mandate manager

-

Linker

Viewer

Viewer

Viewer

Viewer