EUDAMED FAQ: actors, roles and the SRN

By the eudaflow team · Published: 2 October 2026

Who registers as an actor in EUDAMED, why one company can need two SRNs, how an importer links a non-EU manufacturer and what the authorised representative does

Registering a device starts with registering the company. These three questions come up whenever a manufacturer also acts as an importer, sells from outside the EU or works with an authorised representative. Each answer names its official source.

Our company is manufacturer and importer: one SRN or two?

Two. An organisation with more than one actor role registers each role separately and receives a separate Actor ID for each. For economic operators this ID is the SRN, the Single Registration Number. The role is part of the number: an SRN has the format CC-TT-NNN, where CC is the country code, TT is the actor role code and NNN is a nine-digit number.

Registering the same name and address a second time under a different actor type is not treated as a duplicate.

Who has to register:

Manufacturers, importers and authorised representatives register and obtain an SRN.
System and procedure pack producers register too. They receive an Actor ID that is similar to an SRN, so say "Actor ID/SRN" when you mean all roles.
Distributors do not register in EUDAMED. They may still have to register nationally, in the Member State where they make devices available.
Manufacturers (and their authorised representatives), importers and producers that no longer place devices on the market after the UDI/Devices module became mandatory do not need to register. Manufacturers and their authorised representatives must still register if a vigilance or post-market surveillance action is required.

Since 28 May 2026 companies must use the Actor module.

Sources: EUDAMED Information Centre, actor introduction and FAQ on actor registration; business rules for actor registration, BR-ACT-017 and BR-ACT-057; Commission Q&A, Q3 to Q5; Actor registration module. Last checked 29 September 2026.

How does an importer link to a non-EU manufacturer?

The importer creates the link. An importer user with the Linker, LAA or LUA profile does it in the actor module, in five steps:

In the Dashboard, section My Actor, click Link to non-EU manufacturer.
Click Add a new manufacturer.
Find the manufacturer by its Actor ID/SRN. If you do not know it, uncheck "I know the Actor ID/SRN" and search by country and name.
Select the manufacturer and click Add link with this manufacturer.
Enter a start date, and an end date if known, then click Confirm.

The Information Centre pages we read describe the link only from the importer's side and mention no confirmation step by the manufacturer. That is a statement about the documented process, not about what the two companies should agree between themselves.

The Linker profile exists only for importer actors. A link cannot be deleted. It stays for traceability, and the end date shows whether it is still active.

Sources: Link a non-EU manufacturer to an importer; user guide for economic operators; FAQ on actor registration. Last checked 29 September 2026.

What does the authorised representative do for a non-EU manufacturer in EUDAMED?

A non-EU manufacturer needs an active authorised representative (AR) to register as an actor at all. The AR must already be registered in EUDAMED. It verifies the manufacturer's registration request and the summary of the mandate, and only then does the request go to the competent authority responsible for that AR. In device registration the AR is part of the data too: the manufacturer selects the AR for each Basic UDI-DI.

The steps in more detail:

The manufacturer names the AR in its registration request and uploads a mandate summary document.
The AR checks the manufacturer's information and the mandate details. If it approves, the request status changes to Verified and the request goes to the competent authority for validation.
When the manufacturer registers a Basic UDI-DI, it picks the AR from those with which it has an active mandate registered in EUDAMED. The business rules require the AR named on the Basic UDI-DI to be registered and to hold an active mandate with the manufacturer.

Authorised representatives and importers cannot register devices. Manufacturers and system and procedure pack producers do.

Sources: EUDAMED Information Centre, actor introduction; Register as a non-EU manufacturer; Verify non-EU manufacturer registrations; Actor registration module; UDI Devices user guide; UDI Devices business rules, BR-UDID-011. Last checked 29 September 2026.

Sources and how we checked

Every statement above is tied to a quote in a claims register, and a script compares each quote with the current text of its source before we publish. The Information Centre pages are version 2.27.0 of 24 July 2026. This page is general information, not legal advice, and the EUDAMED screens can change with each release.