EUDAMED Actor Registration: How the Single Registration Number Actually Works

The Single Registration Number is the first thing a non-EU manufacturer needs and the first thing most of them get wrong the order of. It is not issued by the Commission, it is not automatic, and it cannot be obtained after the device is on the market. It is issued by a national competent authority after a human being has looked at your submission.

What the Regulation requires

Article 31(1) of Regulation (EU) 2017/745:

"Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers shall, in order to register, submit to the electronic system referred to in Article 30 the information referred to in Section 1 of Part A of Annex VI, provided that it has not already been submitted."

Three actor types, one obligation, one deadline: before placing on the market. Distributors do not register as actors under Article 31; that is a frequent misreading of the economic operator chain.

Article 31(2) then explains where the number comes from:

"After verification of the data ... the competent authority shall obtain a single registration number ('SRN') from the electronic system referred to in Article 30 and issue it to the manufacturer, the authorised representative or the importer."

Verification, then issue. Which is why nobody can promise you an SRN by a given date — the clock belongs to a Member State authority, not to a service provider. Anyone quoting a guaranteed turnaround is selling you something the Regulation does not give them.

Article 31(3) tells you what it is for: "The manufacturer shall use the SRN when applying to a notified body for conformity assessment and for accessing Eudamed in order to fulfil its obligations under Article 29." The SRN is the key to device registration and the reference a notified body asks for on day one of an application.

Who registers whom

For a manufacturer established outside the Union, the registration sequence has a dependency that is easy to miss and expensive to discover late.

The authorised representative registers itself as an actor and obtains its own SRN. The manufacturer is registered in EUDAMED too — and for a non-EU manufacturer the authorised representative normally submits and maintains that registration, because Article 11(3) puts the Article 31 registration obligations on the representative. Article 11(3) requires the representative to comply with the registration obligations laid down in Article 31 and to verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29.

The importer registers separately and holds its own SRN. Article 13 makes importer registration the importer's own obligation, not something the representative discharges on its behalf. If your EU importer has not registered, your chain has a missing link even though your own paperwork is complete.

So the order is: appoint the representative in writing, register the representative and the manufacturer as actors, obtain both SRNs, then register the device under Article 29 — and make sure your importer has done its own.

What Annex VI Part A Section 1 asks for

The actor registration data set is short but it is checked. It covers the type of actor, the name, address and contact details of the actor, the details of the person or persons responsible for the information submitted, and — for authorised representatives — the name, address and contact details of the manufacturer represented. Where the submission is made by a person on behalf of one of the actors, that person's details are also provided.

The evidence that trips up first-time submissions is the mandate. A competent authority verifying an authorised representative's registration expects to see a mandate that satisfies Article 11(2): valid only when accepted in writing by the authorised representative and effective at least for all devices of the same generic device group. A one-line appointment letter, an unsigned draft, or a mandate naming a group of companies rather than one legal person is the usual reason a submission comes back.

Keeping it alive

Two ongoing obligations attach to the SRN, and both are commonly forgotten by companies who treat registration as a one-off.

Article 31(4) requires the actor to update the data within one week of any change to the information submitted under Article 31(1). A new address, a change of contact person, a new manufacturer added to a representative's portfolio — one week.

Article 31(5) requires the actor to confirm the accuracy of the data not later than one year after submission, and every second year thereafter. Failure to comply exposes the registration to action by the competent authority. An SRN is not a certificate you file away; it is a record you maintain.

What changed on 28 May 2026

EUDAMED spent years as a voluntary system, and a great deal of published advice still assumes that. It is out of date. Under Commission Decision (EU) 2025/2371 of 26 November 2025, the actor registration module, the UDI and device registration module, the notified bodies and certificates module, and the market surveillance module became mandatory on 28 May 2026.

The practical effect for a new manufacturer is simple: there is no longer a national-registration workaround to fall back on for these modules, and there is no longer a reason to defer registration until the device is ready to ship. Registration is upstream of labelling, because the representative's name and address and the UDI carrier belong on the packaging you are about to print.

Legacy devices — those still on the market under a valid Directive certificate during the Article 120 transition — have their own registration position, which we cover in our note on EUDAMED registration for legacy devices.

Device registration is a separate step

Actor registration gets you an SRN. It does not put your device in EUDAMED. Article 29(1) requires the manufacturer, before placing a device on the market, to assign a Basic UDI-DI as defined in Part C of Annex VI and to provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI.

The Basic UDI-DI is the device model identifier — the one that appears on the declaration of conformity under Annex IV point 3 and groups devices of the same intended purpose, risk class and essential design characteristics. It is not the UDI-DI printed on the package. Both come from an issuing entity designated by the Commission: GS1, HIBCC, ICCBBA or IFA. Our note on the Basic UDI-DI sets out the difference.

Where this sits in the sequence

Qualification, classification, technical documentation, conformity assessment, representative appointment, actor registration, device registration, then labelling and the declaration of conformity. The bolded middle is where the most avoidable delay lives, because it depends on a third party — a competent authority — and on a document, the mandate, that has to be right the first time.

Medex acts as EU authorised representative for manufacturers outside the Union, with actor registration, manufacturer registration and UDI and device registration included in the mandate rather than billed as extras. Our class-based rates are published.

Sources (official)

Regulation (EU) 2017/745, Articles 11, 13, 27, 29, 30 and 31, and Annex VI Parts A, B and C

Regulation (EU) 2017/746, Articles 11, 26, 28 and 29

Commission Decision (EU) 2025/2371 of 26 November 2025 on the functionalities of the European database on medical devices

Commission Implementing Decision (EU) 2019/939 designating issuing entities for the UDI system

MDCG 2021-13 — Questions and answers on obligations and related rules for the registration in EUDAMED of actors

European Commission — EUDAMED actor registration module

Who wrote this

Medex is a medical device manufacturer established in Ankara and a registered authorised representative in EUDAMED under SRN TR-AR-000057550, verifiable in the EUDAMED public actor database. We file actor, mandate and UDI records for our own devices before we file them for anyone else. We are not a law firm and do not provide legal advice.