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User rights & profiles

Notified Body (NB) users do not have a EUDAMED account with any other actor type; and can only enter data in the NBs & Certificates module.

Profiles are module-specific and hierarchical, i.e. higher level profiles contain all lower level grants/rights, e.g. the Local Actor Administrator (LAA) is the highest profile in the Actor module and contains the rights of all lower profiles.

User profiles available to a Notified Body:

User profile

Module

Rights

Viewer

Actor

View registered actors

Local User Administrator (LUA)

Actor

Viewer + manage users and user access requests

Local Actor Administrator (LAA)

Actor

LUA + manage actor notification email addresses

Viewer

Devices

View devices in states Registered and Submitted

Confirmer

Devices

Viewer + register SS(C)P records in the UDI/Device module

Viewer

Certificates

View certificate module records in state Draft and Registered

Proposer

Certificates

Viewer + enter, delete and update certificate module records in state Draft

Confirmer

Certificates

Proposer + submit and delete certificate module records in state Registered

Viewer (slim)

Market Surveillance

View market surveillance procedures and final inspection reports where the NB is referenced

Viewer (slim)

Vigilance

View Vigilance reports in state Registered where the NB is referenced

Viewer (fat)

Vigilance

View Vigilance reports in state Registered where the NB is referenced

Proposer

Vigilance

View Vigilance reports in state Registered where the NB is referenced

Confirmer

Vigilance

View Vigilance reports in state Registered where the NB is referenced and provide an Evaluation for the latest version of the PSUR where the NB is referenced