Actor registration is the gate every downstream EUDAMED module passes through. Without an active SRN, the UDI/Devices module rejects submissions, the Notified Bodies & Certificates module cannot link a certificate to an unregistered manufacturer, and vigilance reporting has no operator to attach to. The Actor module became mandatory to use on 28 May 2026 under Commission Decision (EU) 2025/2371. This page covers the three load-bearing flows: EU-established manufacturer, non-EU manufacturer routed through an authorised representative, and importer. If you are already registered and looking for the login, EUDAMED is at webgate.ec.europa.eu/eudamed.
The EUDAMED Actor module and the economic-operator actor roles
The Actor module is the first of the six EUDAMED modules, per the EC EUDAMED Actor registration module page. The other five are UDI/Devices, Notified Bodies & Certificates, Market Surveillance, Vigilance and Post-Market Surveillance, and Clinical Investigations and Performance Studies. The first four became mandatory to use on 28 May 2026; Vigilance and PMS, and Clinical Investigations, remain pending separate Commission decisions on functionality.
EUDAMED recognises four economic-operator actor roles, named on the EC Actor roles and Actor ID/SRN infographic:
Distributors do not register in EUDAMED. MDR Article 14 sets distributor obligations without creating an EUDAMED actor role for them. National competent authorities, designating authorities, notified bodies and the Commission appear in EUDAMED as supervising entities rather than as actors; they participate in the system but they do not file an actor registration request and they do not receive an SRN.
Who registers, and who registers on whose behalf
Every EU-established economic operator registers itself with its own national competent authority. The competent authority is determined by the operator’s place of establishment, not by where the operator’s devices will be sold. A Munich-based manufacturer registers with BfArM in Germany; a Brussels-based importer registers with FAMHP in Belgium.
Non-EU manufacturers do not register themselves directly. Under MDR Article 11(3), a non-EU manufacturer appoints a single EU-established authorised representative by written mandate, and the AR submits the actor registration request on the manufacturer’s behalf. The assessing authority is the AR’s member-state competent authority, not the manufacturer’s country of incorporation. The same routing applies under IVDR Article 11 for in vitro diagnostics.
Importers register independently of the manufacturers they import for. The importer is its own economic operator with its own SRN, and the importer’s competent authority is the importer’s member state. An importer that brings a device from a Korean manufacturer (which is registered through a Dutch AR with CIBG/Farmatec) into Belgium still registers itself with FAMHP. The three registrations are parallel, not nested.
Distributors do not register, by design under MDR Article 14: a distributor’s obligations are inspection, verification and traceability of devices already on the market, not market entry. Distributors that take on labelling, translation or repackaging activities can fall into the importer or manufacturer role under MDR Article 16 and then register as that role.
The non-EU manufacturer flow: registering via your authorised representative
This is the most under-documented sub-flow in the public source base, and it is the one most likely to stall. The non-EU manufacturer cannot submit an actor registration request itself. The EU-established AR has to do it, has to upload a specific document the EU manufacturer flow does not require, and has to deal with the AR’s own member-state authority rather than the manufacturer’s country authority. Two SRNs come out at the end, one for the AR and one for the non-EU manufacturer, and both have to be in place before a device record can be submitted.
The sequence runs as follows:
- The non-EU manufacturer appoints an EU-established AR by written mandate under MDR Article 11. The mandate defines the scope of tasks the AR performs on the manufacturer’s behalf and is signed by both parties.
- The AR registers itself in EUDAMED as an actor in its own right, with its own member-state competent authority. The AR receives its own SRN (format
XX-AR-NNNNNNNNN, whereXXis the AR’s country ISO2 code). - The AR submits a separate actor registration request for the non-EU manufacturer. With this request, the AR uploads the mandate summary document, an EC template that summarises the written mandate signed in step 1. The EC publishes the template at
md_mandate_summary_en.pdf. - The AR’s national competent authority assesses the request. On approval, EUDAMED issues a second SRN, this one for the non-EU manufacturer (format
XX-MF-NNNNNNNNN, whereXXis again the AR’s country ISO2 code; the manufacturer’s actual country of incorporation does not change the routing). - The AR and the non-EU manufacturer each hold a distinct SRN. UDI/Device records cite the manufacturer’s SRN; the AR’s SRN appears in the supply-chain section.
A non-EU manufacturer routed through a German AR receives a German-prefixed SRN even if the manufacturer is incorporated in the United States, the United Kingdom or Japan. The assessing authority is BfArM, the SRN country code is DE, and the geography on the SRN reflects the AR’s establishment rather than the manufacturer’s.
A worked example. A US-incorporated manufacturer appoints a Munich-based AR already registered with BfArM under SRN DE-AR-000123456. The AR submits a separate request for the US manufacturer with the mandate summary attached. BfArM assesses; on approval EUDAMED issues DE-MF-000456789 to the US manufacturer. Both SRNs are now active, both appear in the public Actor search, and the AR can file UDI/Device records citing DE-MF-000456789.
The Single Registration Number: structure and what it unlocks
The SRN is the load-bearing identifier across EUDAMED. Once an actor registration is approved, EUDAMED generates the SRN, the national competent authority transfers it to the requesting operator, and the operator uses it in every downstream submission.
The SRN structure has three labelled segments, per the EC Actor roles and Actor ID/SRN infographic:
| Segment | Length | Source | Example |
|---|---|---|---|
| Country ISO2 code | 2 characters | ISO 3166-1 alpha-2 code of the assessing authority’s member state | BE |
| Actor role abbreviation | 2 characters | MF, AR, IM or PR | MF |
| Serial number | 9 digits | Assigned by EUDAMED at issuance | 000000001 |
The three segments combine into the canonical form BE-MF-000000001. The EC documentation calls the identifier an SRN when the actor is a manufacturer, authorised representative or importer registered pursuant to MDR Article 31 or IVDR Article 28; for other actors (notably system or procedure pack producers), the EC documentation calls the identifier an Actor ID. Both identifiers share the same structure and the same EUDAMED-generation mechanic; the naming difference reflects the underlying regulation cited.
One actor role equals one SRN. An organisation that acts as both manufacturer and importer submits two requests and receives two identifiers. The EC publishes a Belgian example on the SRN infographic: the same entity acting as manufacturer and importer receives BE-MF-000000002 and BE-IM-000000003. The records are independent and linked only through the underlying legal entity name.
The SRN unlocks every downstream module. UDI/Device records cite the manufacturer’s SRN as the registering operator and the importer’s SRN in the supply-chain section. Notified Bodies & Certificates records cite the manufacturer’s SRN on the certificate linkage. Vigilance reports cite the SRN of the operator filing the report. The actor registration step gates every other registration activity for that reason.
The SRN is distinct from the EUDAMED ID. The EUDAMED ID is the device-level identifier issued by EUDAMED for a device record, used for legacy devices that have no Basic UDI-DI; the SRN identifies the operator, the EUDAMED ID identifies the device.
The importer flow: when an importer registers, and what they upload
An EU-established importer registers as its own actor under MDR Article 13 / IVDR Article 13. The importer’s competent authority is the importer’s member state, irrespective of where the manufacturer or the AR is established. An importer in Antwerp registers with FAMHP. An importer in Rotterdam registers with CIBG/Farmatec. An importer in Vienna registers with BASG.
The importer’s documentation is lighter than the AR’s. There is no mandate to summarise (the importer does not act on the manufacturer’s behalf in the legal sense the AR does), but the importer does upload the declaration on information security responsibilities, which every actor signs and uploads with the registration request. Incorporation details, registered organisation name, business address and contact person complete the request.
After SRN issuance, the importer’s role in EUDAMED is to be listed as the importer in the supply-chain section of UDI/Device records for each device the importer brings into the EU market. The linkage is manufacturer SRN → device record → importer SRN. The importer does not submit device records itself in most configurations; the manufacturer (or the AR, for non-EU manufacturers) is the device-record submitter, and the importer appears as a supply-chain entry on each affected record.
MDR Article 16 carves out a category in which an importer or distributor that modifies a device, repackages it under its own brand, or translates the IFU in a way that affects intended purpose takes on manufacturer obligations. In that case the entity registers as a manufacturer in addition to its importer registration and receives a second SRN. Most importers do not cross the Article 16 threshold.
Member-state competent authorities: who assesses your request
The national competent authority is the body that assesses an actor registration request and, on approval, transfers the SRN that EUDAMED generates. Each member state designates its competent authority under MDR Article 101 and publishes the authority’s contact details. The Commission maintains the consolidated list through the Competent Authorities for Medical Devices (CAMD) network.
The five most-visible authorities on EUDAMED actor registration in 2026 are below. The authority is determined by the operator’s place of establishment, not by ranking or quality. List scope and link, do not pick.
| Authority | Country | Actor types assessed | Authority-specific notes | Authority page |
|---|---|---|---|---|
| BfArM | Germany | EU manufacturer, AR (default for many non-EU mfrs), importer, SPPP | Default assessing authority for non-EU manufacturers routed through a German AR; the largest single-authority caseload in the EU on actor registration | bfarm.de |
| BASG | Austria | EU manufacturer, AR, importer, SPPP | Published a banner in March 2026 confirming the 28 May 2026 mandatory date and detailing actor request submission | basg.gv.at |
| FAMHP | Belgium | EU manufacturer, AR, importer, SPPP | Published Q&A on actor registration covering documentation, language and verification expectations | famhp.be |
| Farmatec / CIBG | Netherlands | EU manufacturer, AR, importer, SPPP (registration-side) | Runs the uniqueness, completeness and NL-establishment check; the page is among the most-cited authority pages on the SRN public search lookup | english.farmatec.nl |
| IGJ | Netherlands | EU manufacturer, AR, importer, SPPP (inspectorate-side) | Dutch Health and Youth Care Inspectorate; sits alongside Farmatec on the NL actor registration path and covers the post-registration supervisory role | english.igj.nl |
Every other EU and EEA member state has a designated competent authority that performs the same function: HSE in Ireland, ANSM in France, AEMPS in Spain, AIFA and the Ministry of Health in Italy, and so on. The routing rule is identical regardless of which authority assesses the request.
Timeline to SRN varies by authority and request quality. Some authorities publish working-day commitments; many publish none. In practice, well-prepared requests at smaller-caseload authorities clear in two to three weeks; at higher-caseload authorities, particularly around the 28 May 2026 cliff, requests can run six weeks or longer. A rejected request restarts the cycle, which is why the first-submission accuracy of incorporation documents, contact details and (for non-EU + AR) the mandate summary determines real elapsed time more than authority choice does.
Documents to provide with the actor registration request
The EC EUDAMED Actor registration module page names two specific documents every actor request requires, the second of which applies only to non-EU manufacturers. Authority-specific incremental requirements (notarised translations, original chamber-of-commerce extracts, specific contact-person designations) sit on top of the EC baseline.
| Document | EU manufacturer | AR (for non-EU mfr) | Non-EU manufacturer (via AR) | Importer |
|---|---|---|---|---|
| Incorporation document (chamber-of-commerce extract or equivalent) | Required | Required | Required (provided by the AR with the request) | Required |
| Registered organisation name and address | Required | Required | Required | Required |
| Contact person (with email and phone) | Required | Required | Required | Required |
| Declaration on information security responsibilities (EC template, signed) | Required | Required | Required | Required |
| Mandate summary document (EC template, signed by mfr and AR) | Not required | Not required | Required (uploaded by the AR with the request) | Not required |
| Written mandate between manufacturer and AR (referenced by the mandate summary) | Not required | Held by AR | Held by AR | Not required |
| Declaration that the operator imports devices into the EU | Not required | Not required | Not required | Required |
The declaration on information security responsibilities is signed and uploaded by every actor; the EC publishes the template in all EU languages from the Actor module page. The mandate summary document is the EU-canonical template the AR uses to summarise the written mandate; the underlying mandate stays with the AR and is produced on request by the competent authority during assessment. National authorities may require additional artefacts, including notarised translations of incorporation documents for non-EU manufacturers and specific declarations on micro/small enterprise status where the PRRC is external; check the assessing authority’s page before submission.
After submission: timeline, status and the EUDAMED public Actor search
The competent authority assesses the request, generates and transfers the SRN on approval, and the registered actor then appears in the public Actor search at webgate.ec.europa.eu/eudamed/public.html. The lookup returns the actor’s registered name, country of establishment, actor role and SRN. Any party (counterparty, notified body, inspecting authority) can confirm an SRN through it.
On rejection the operator resubmits with the defect corrected. The three most common rejection causes, derived from the EC FAQ and published authority guidance, are:
- Duplicate registration. An operator already holds an SRN for the same actor role with the same authority. The fix is to retrieve the existing SRN through the public search and confirm whether a new role registration is needed instead.
- Incomplete mandate summary for non-EU + AR submissions. The AR has not uploaded the signed mandate summary document, or the document does not match the scope of the written mandate. The fix is to re-sign and re-upload the EC template with all required fields.
- Establishment mismatch. The operator’s declared registered office does not match the authority’s records (typically the chamber of commerce or the equivalent national register). The fix is to align the EUDAMED submission with the authority’s source-of-truth record, not the other way around.
Once the SRN is active, the next step is UDI/Device registration in the UDI/Devices module. See the EUDAMED registration overview for the end-to-end view and the deadlines page for the legacy-device 28 November 2026 cutoff.