Registering a device in EUDAMED is a two-module workflow. First the organisation registers as an actor in the Actor Registration module to obtain a Single Registration Number (SRN); MDR Article 31 holds the obligation and the competent authority of the home Member State reviews and approves the request. Then, with the SRN active, the manufacturer enters device records in the UDI/Devices module under MDR Article 29, starting at the Basic UDI-DI level and attaching UDI-DI records beneath. The order is enforced inside the database: the UDI/Devices module rejects submissions citing an SRN that is not yet active. Three sub-flows diverge at specific points, EU manufacturer, non-EU manufacturer with an EU authorised representative, and importer; this walkthrough covers all three. The 28 May 2026 and 28 November 2026 deadlines that govern the timing sit on the deadlines page; the architectural overview lives on the EUDAMED registration pillar.
Actor first, devices second. The Actor Registration module issues the SRN. The UDI/Devices module rejects any device submission whose SRN is not yet active in the database. Preparation work on device records can run in parallel, but submission cannot.
Step 1. Actor registration: getting your SRN
The Actor module is where the economic operator records its legal identity in EUDAMED and the competent authority confirms the record. The module covers four actor roles: manufacturer (MDR Article 29 / IVDR Article 26 obligations), authorised representative (MDR Article 11), importer (MDR Article 13), and producer of systems and procedure packs. Distributors do not register; their obligations under MDR Article 14 do not include an EUDAMED actor entry.
Before you start: choosing your actor role
The actor role you select on the first screen determines the data the module asks for and the documents the competent authority expects. Pick the role that matches the legal entity placing the device on the EU market, not the role of the group parent or the local affiliate. A non-EU manufacturer registers as Manufacturer once its authorised representative is registered; the manufacturer record cites the AR’s SRN. An importer registers as Importer in its own right and links to the manufacturer’s or AR’s device records once those exist.
| Role | Applicable MDR Article | What gets issued | When it registers |
|---|---|---|---|
| Manufacturer (EU) | Article 29 (device); Article 31 (actor) | Manufacturer SRN | First in the EU-manufacturer sub-flow |
| Manufacturer (non-EU) | Article 29, Article 31 | Manufacturer SRN | After the authorised representative has its AR SRN |
| Authorised representative | Article 11, Article 31 | AR SRN | First in the non-EU-manufacturer sub-flow |
| Importer | Article 13, Article 31 | Importer SRN | After the manufacturer (or AR) has its SRN |
| System/procedure pack producer | Article 22, Article 31 | Producer SRN | Independent of the manufacturer flow |
Creating an EU Login account
The Actor module sits behind EU Login, the Commission’s single-sign-on layer. The first user creates an EU Login account at the Commission’s authentication service, then signs in to EUDAMED at webgate.ec.europa.eu/eudamed/landing-page. The account is personal, tied to a named individual; do not use a generic shared mailbox for the EU Login email. Generic mailboxes are one of the routine rejection grounds the Member State competent authorities cite when the actor request is reviewed.
The seven screens, walked through
The Actor Registration form runs across seven screens. The screens vary slightly by actor role; this walkthrough covers the manufacturer flow, with notes on where the AR and importer flows diverge.
- Actor identification. Legal name as it appears on the trade-register entry, registered address, country, contact email, contact phone, language. The legal name must match the Chamber of Commerce or National Business Register entry character-for-character; punctuation and abbreviations matter at competent-authority review.
- Actor role and organisation type. Manufacturer / AR / importer / SPPP. For manufacturers, the form asks whether the organisation is established in the EU. Non-EU manufacturers select No and cite the AR’s SRN later; the AR must already hold an active SRN at this point.
- Tax and legal identifiers. VAT number, Chamber of Commerce or National Business Register number, EORI where applicable. The competent authority cross-checks these against the underlying register; a mismatch on the legal name, the registered address, or the Chamber of Commerce number is rejected without further dialogue.
- Local Actor Administrator (LAA). Name, role, work email, work phone for the user who will manage the EUDAMED profile after issuance. The LAA approves subsequent user requests under the profile (LUA, Viewer, Linker) and represents the organisation in EUDAMED. The LAA email must be a named work mailbox, not a generic group address.
- Role-specific data. For manufacturers: SME status under Commission Recommendation 2003/361/EC, whether the PRRC under MDR Article 15 is internal or external, and the manufacturer’s quality-management system reference where required. For ARs: the mandate document from the non-EU manufacturer. For importers: the manufacturer or AR whose devices the importer expects to place on the market.
- Documents to upload. The Declaration on Information Security Responsibilities (the EC-provided template), signed by the LAA. For ARs, the signed mandate from the non-EU manufacturer. For micro and small enterprises with an external PRRC, the SME declaration referencing Recommendation 2003/361/EC.
- Review and submit. A summary view of every field entered, the documents attached, and the LAA contact. Submission routes the request to the competent authority of the home Member State (BfArM, Farmatec, FAMHP, BASG, AIFA and so on); the authority reviews and either approves, requests clarification, or rejects.
After approval, EUDAMED issues the SRN. The SRN is a 13-character alphanumeric identifier with three parts: a 2-letter ISO country code for the actor’s home Member State, a short actor-type code (MF, AR, IM, PR), and a 9-digit sequence number assigned by EUDAMED. Competent authorities target a 30-day review window; complex cases run longer, and a rejection-and-resubmission loop typically adds 7 to 14 days per cycle.
Common rejection reasons
Three rejection patterns account for most actor-request failures, and they recur across competent authorities. Five member-state authorities publish guidance on them.
- Generic LAA email. The form requires a named work mailbox. Shared addresses (
info@,regulatory@,quality@) are rejected by BfArM, Farmatec and FAMHP on first review. - Missing SME declaration when the PRRC is external. MDR Article 15(2) allows a micro or small enterprise to rely on an external PRRC, but only with a corresponding declaration referencing Recommendation 2003/361/EC. The Actor module does not enforce the SME-declaration upload; the competent authority does, and rejects without it.
- Data mismatch with the trade register. Legal name, registered address, Chamber of Commerce number, VAT number. The competent authority cross-checks each field against the underlying register and rejects on the first mismatch. Free-text differences (an abbreviation in the EUDAMED entry that the register spells out, or vice versa) are mismatches.
Member-state authorities add their own checks. Each authority publishes guidance for the actors registering through it, and each correspondence pattern differs.
Verifying your SRN is live
After competent-authority approval, the SRN appears in the public EUDAMED actor search within hours. The organisation name searched returns the SRN, the actor role, and the home Member State. The same SRN is visible on the member-state authority page for actors registered through that authority.
Adding users to your registered actor
Once the SRN is active, the LAA can add users to the profile through the New Access Request flow. The LAA approves each new access request from the profile dashboard. EUDAMED defines four access roles inside an actor profile.
| Role | Who creates it | Privileges | Typical user in the organisation |
|---|---|---|---|
| LAA (Local Actor Administrator) | First user, confirmed in the actor request by the competent authority | Full access to the profile; approves and revokes other users; signs the Declaration on Information Security Responsibilities | Senior RA or PRRC |
| LUA (Local User Administrator) | LAA assigns | Manages the user list within the profile; cannot approve a new LAA | Designated RA administrator |
| Viewer | LAA assigns | Read-only access to the actor and device records | Audit, QA, internal review |
| Linker (importer profiles only) | LAA assigns on an importer profile | Links the importer profile to manufacturer and AR device records once those records exist | Importer-side RA |
Step 2. Device registration: registering devices against your SRN in the UDI/Devices module
The UDI/Devices module is where device records are entered against an active SRN. The module enforces a hierarchy: a Basic UDI-DI record at the device-family level, with UDI-DI records as children beneath it. MDR Article 27 sets the UDI structure; MDR Article 29 sets the device-registration obligation; IVDR Article 26 carries the parallel IVD obligation. The full module documentation lives on the EC’s UDI/Devices module page.
Prerequisites: SRN issued and Basic UDI-DI assigned
Two prerequisites must hold before a device record can be entered. The SRN must be active (Step 1 above), and the Basic UDI-DI must already be assigned by a UDI issuing entity recognised by the Commission: GS1, HIBCC, IFA or ICCBBA. The issuing-entity rules sit in MDCG 2018-1 Rev. 4 and MDCG 2021-1 Rev. 2.
Entering Basic UDI-DI and UDI-DI
The four UDI identifiers that the module asks for sit in a fixed hierarchy. Each row of the table corresponds to a specific field on the device record.
| Identifier | What it identifies | Who assigns | UDI/Devices module field | Mandatory under | When EUDAMED-DI substitutes |
|---|---|---|---|---|---|
| Basic UDI-DI | Device-family identifier | Issuing entity (GS1, HIBCC, IFA, ICCBBA) | Basic UDI-DI record | MDR Article 27 | Replaced by EUDAMED-DI for legacy devices |
| UDI-DI | Unit-of-trade identifier | Issuing entity | UDI-DI sub-record beneath Basic UDI-DI | MDR Article 27, Article 29 | Replaced by EUDAMED-DI for legacy devices |
| UDI-PI | Production identifier (lot, serial, expiry) | Manufacturer | Production data tied to UDI-DI | MDR Article 27 | Not separately recorded for legacy entries |
| EUDAMED-DI / EUDAMED ID | Legacy-device identifier | EUDAMED itself, on entry | Legacy-record top entity | Implementing Regulation (EU) 2024/1860 | Used when the device lacks a Basic UDI-DI |
Entering a Basic UDI-DI is a single screen with three blocks of fields. First, the Basic UDI-DI code, the manufacturer SRN, the EMDN code, the risk class and the applicable legislation (MDR or MDD/AIMDD for legacy under that route). Second, the family-level attributes: single-use, sterile, reusable surgical, implantable, software, containing a medicinal substance, containing materials of human or animal origin. Third, submission. Once the Basic UDI-DI is accepted, attach UDI-DI children: for each commercial configuration of the family, a UDI-DI code, a status flag and the unit-level attributes.
Selecting the EMDN code
The EMDN code is selected from the EC’s published nomenclature, a seven-level tree of around 8,500 codes. The module accepts the leaf-level code; ancestor levels are validated against the tree. A withdrawn revision is rejected at validation; the current EMDN version is published on the EC’s EUDAMED tools page and updated quarterly.
Setting device status and packaging levels
Each UDI-DI carries a status field: on the EU market, not intended for the EU market, or no longer placed on the EU market. The module also accepts container packaging levels for higher-pack-level identifiers (a unit pack containing multiple UDI-DI units). The packaging level is its own UDI-DI structure, not a separate entity.
Linking to your Notified Body certificate
For higher-risk classes the device record links to the Notified Body certificate held in the Notified Bodies & Certificates module. The link is mandatory for Class IIa, IIb and III medical devices and for Class C and D IVDs. The Notified Body uploads the certificate; the manufacturer’s device record references it by certificate number and Notified Body identification number (the four-digit code the Commission assigns to designated bodies). For Class I medical devices and Class A IVDs without Notified Body involvement, the certificate field is left blank.
Legacy device flow: Basic UDI-DI to EUDAMED-DI substitution
Legacy devices on extended certificates under Regulation (EU) 2024/1860 follow a different identifier path. The device does not carry a Basic UDI-DI assigned by an issuing entity. Instead, on the first legacy-device entry the UDI/Devices module generates an EUDAMED-DI identifier that occupies the same hierarchical position. EUDAMED ID children sit beneath the EUDAMED-DI in the place of UDI-DI children. Commission Decision (EU) 2025/2371 sets the 28 November 2026 mandatory-use date for the legacy entries; MDCG 2019-5 documents the EUDAMED-DI mechanic. The deadlines are covered in detail on the deadlines page.
Timeline expectations: deadlines, prep time, EC processing
Three timing layers govern a registration push.
- Regulatory deadline. 28 May 2026 for new MDR and IVDR registrations; 28 November 2026 for legacy devices under Regulation (EU) 2024/1860. Both anchored in Commission Decision (EU) 2025/2371.
- Internal preparation time. Highly variable. A portfolio with structured device data and a complete EMDN mapping can prepare records in days. A portfolio that needs an EMDN mapping pass, a Basic UDI-DI issuing-entity setup, or a Notified Body certificate-linkage reconciliation routinely runs several weeks.
- EC processing time after submission. For non-NB-routed devices (Class I medical devices, Class A IVDs) the device record posts immediately on validation; the public EUDAMED entry appears within hours. For Notified-Body-mediated devices the record waits on the certificate linkage from the Notified Bodies & Certificates module; the lag depends on the Notified Body and the certificate-upload cadence.
Step 3. Sub-flow comparison: EU manufacturer, non-EU manufacturer with EU authorised representative, importer
The three sub-flows diverge at specific points in the Actor module: at the role-selection screen and at the role-specific data screen. The UDI/Devices module is the same for all three sub-flows. The manufacturer SRN drives the device record, and the importer links through a separate flow once devices are registered.
| EU manufacturer | Non-EU manufacturer with EU AR | Importer | |
|---|---|---|---|
| Who registers first | The manufacturer | The authorised representative | The manufacturer (or AR) registers first; the importer registers second |
| What SRN / ID is issued | Manufacturer SRN | AR SRN, then Manufacturer SRN against the AR | Importer SRN |
| Applicable MDR Article | Article 29 (device); Article 31 (actor) | Article 11 (AR role and obligations); Article 31 | Article 13 (importer); Article 31 |
| Prerequisite from a different actor | None | AR registration must complete first; the manufacturer record cites the AR’s SRN | Manufacturer or AR registration must complete first; the importer links to manufacturer device records once issued |
| Typical timeline before device registration can begin | Single competent-authority review window (typically 30 days) | Two sequential review windows (AR first, then manufacturer); total time is roughly twice the single-window figure | Single competent-authority review window for the importer SRN; device-link flow opens once the manufacturer’s device records exist |
What about distributors?
Distributors do not register an actor record in EUDAMED. MDR Article 14 governs distributor obligations and does not impose an EUDAMED actor entry. A distributor verifies the manufacturer’s actor registration, the device’s CE marking and UDI assignment, and (where applicable) the importer’s actor record before placing the device on the market downstream; the distributor itself is not visible in the EUDAMED actor search.
Step 4. After registration: verification, updates, and what changes for vigilance
The device record is live once the UDI/Devices module accepts the submission and (for Notified-Body-routed classes) the certificate linkage resolves. Three operational concerns follow.
Verifying your device record is live
The device search on the public EUDAMED interface returns Basic UDI-DI records by code, by manufacturer SRN, or by EMDN. A live record returns a matching hit within hours of acceptance. A record that does not return on search after that window has either failed validation silently (a rare module state) or is held on the Notified Body certificate-linkage flow.
Updating registered data
Changes to a registered device must be reflected in EUDAMED within one week of the change taking effect, per the update obligation in MDR Article 31(4) and the corresponding IVDR provision. Some fields are non-editable once a record has been submitted: identifier fields (Basic UDI-DI, UDI-DI, EUDAMED-DI), the applicable legislation, and a small set of structural attributes. Changes to non-editable fields require a new record under the corrected values; the older record is then end-of-life-flagged through the device-status field rather than overwritten.
What changes for vigilance once your device is registered
The Actor module registration is the prerequisite for vigilance reporting once the Vigilance and Post-Market Surveillance module goes mandatory. The Commission has not yet adopted a functionality decision for that module; the EC’s published roadmap points to later in 2026, and a subsequent decision under MDR Article 34(3) is needed to bring it into mandatory use. Until then, vigilance reporting continues through national channels at the competent authority. For the broader deadlines context, see the EUDAMED deadlines page.