The Registration Order
Under MDR Article 31 and IVDR Article 28, manufacturers, authorised representatives and importers must register in EUDAMED before placing a device on the market, unless they have already registered. The two are close but not identical: MDR Article 31 carves out custom-made devices, and IVDR Article 28 has no such carve-out. Separately, MDR Article 11 requires a manufacturer not established in a Member State to designate a sole authorised representative. The regulations impose those duties on each actor separately; neither says how EUDAMED must sequence the submissions. EUDAMED does add a step for manufacturers established outside the EU: the request is routed through the designated authorised representative. That sequencing is a property of the system, not a separate legal obligation.
EUDAMED's own guidance for the non-EU manufacturer registration step is explicit about what has to exist first: the authorised representative (AR) must already be registered in EUDAMED, with an Actor ID or Single Registration Number (SRN) issued, before the manufacturer can submit its own registration request.
This is easy to miss because nothing in the day-to-day language of "registering as a manufacturer" signals a dependency on someone else's registration status. An EU-based manufacturer, an authorised representative, an importer, and a system or procedure pack producer all register the same way: submit a request, a competent authority assesses it, an Actor ID/SRN comes back. (System and procedure pack producers, and actors registering only legacy, custom-made or "old" devices, receive an Actor ID that is not an SRN.) A non-EU manufacturer's request has an extra actor and an extra precondition in the middle of that chain.
Two Different Registration Flows
The Commission publishes separate process diagrams for these two cases. An EU manufacturer, an authorised representative, an importer, or a system/procedure pack producer submits its registration request directly to a competent authority for assessment. A non-EU manufacturer's request goes through one additional step: its named authorised representative verifies the request first, and only then is it passed on for assessment.
| Step | EU Actor (Manufacturer, AR, Importer, SPPP) | Non-EU Manufacturer |
|---|---|---|
| Submit request | Directly to the competent authority | To the authorised representative named in the request |
| Verification | Not applicable, goes straight to assessment | The named authorised representative verifies the request before it moves on |
| Assessment authority | The competent authority for that actor's own registration | The competent authority responsible for the authorised representative, not the manufacturer's home country |
| Outcome | Actor ID/SRN generated by EUDAMED and issued by the competent authority on approval, or corrections requested, or final refusal | Same three outcomes, reached one step later |
The verification step only works if there is an approved, registered authorised representative to do the verifying. That is the mechanical reason the AR has to exist in EUDAMED, with its SRN already issued, before the manufacturer's request is submitted.
What You Need Before You Submit
Beyond the authorised representative's SRN itself, a non-EU manufacturer's registration request needs specific supporting material ready at submission time, not assembled afterward:
- The AR's SRN, or enough to find it. The registration form identifies the authorised representative either by its SRN directly or by a country-plus-name search, which returns nothing if the AR has not registered, and also if it registered under a different name.
- Mandate validity dates. The start (and, where applicable, end) date of the written mandate between the manufacturer and its authorised representative.
- A summary mandate document. The full mandate text is not required; a summary, uploaded as a PDF of no more than 10MB, is what the form asks for. EUDAMED publishes a template for it.
- A signed declaration. A separate signed PDF, distinct from the mandate summary, and likewise capped at 10MB. This is the declaration on information security responsibilities required by Commission Implementing Regulation (EU) 2021/2078, Article 3(4).
None of this material is unusual or hard to produce. What causes delay is producing it before confirming the one thing it all depends on: that the named authorised representative's own EUDAMED registration has already been approved.
Step-by-Step Sequencing
- Confirm or establish the mandate. The manufacturer and its chosen EU authorised representative agree the written mandate covering the devices in scope.
- Confirm the AR's EUDAMED status. Check whether that authorised representative already has an approved actor registration and an issued Actor ID/SRN. The registration form's own search finds an AR either by its Actor ID/SRN or by country and name. If that search returns nothing, EUDAMED's guidance is to contact the authorised representative directly to confirm its Actor ID/SRN, since it may not have registered yet or may have registered under a different name. If it is registering for the first time, its own request has to clear its competent authority first.
- Assemble the manufacturer's submission material. Mandate validity dates, the summary mandate document, and the signed declaration, once the AR's SRN is confirmed and ready to reference.
- Submit the manufacturer's registration request, identifying the authorised representative by its SRN.
- Wait for AR verification, then competent-authority assessment. The named authorised representative verifies the request; the competent authority responsible for that AR then assesses it and, on approval, issues the manufacturer's own Actor ID/SRN, generated by EUDAMED.
What Goes Wrong When the Order Is Skipped
| Mistake | What Happens | Correct Approach |
|---|---|---|
| Manufacturer starts its registration before checking the AR's EUDAMED status | The AR cannot be identified by SRN, or a country/name search returns nothing, and the request cannot be completed as drafted | Verify the AR's SRN exists and is active before assembling the manufacturer's own submission material |
| Treating a newly engaged AR as "registered" because a mandate was signed | A signed mandate is a private agreement between manufacturer and AR; it does not itself register the AR in EUDAMED or produce an SRN | Confirm the AR's EUDAMED registration was separately submitted and approved, with its own SRN issued, independent of the mandate |
| Assuming the manufacturer's home-country authority will assess its request | For a non-EU manufacturer, assessment routes through the competent authority responsible for the named authorised representative, not the manufacturer's own country | Plan around the AR's competent authority, not an assumption based on the manufacturer's location |
| Uploading the full mandate contract instead of a summary | EUDAMED asks only for a summary and publishes a template for it. The full contract is not required: "You don't have to upload the full mandate text." | Prepare the summary mandate document the form specifies, separate from the full underlying contract |
Primary Sources
The sequencing described in this guide comes directly from the Commission's own EUDAMED system documentation, not from secondary interpretation.
| Document | Covers |
|---|---|
| EUDAMED Help: Register as a Non-EU Manufacturer | States the AR-first precondition directly, and lists the exact form fields and documents (mandate dates, summary mandate, signed declaration) |
| EUDAMED Actor Registration Request Process (European Commission, DG SANTE) | The Commission's own process diagrams, showing the extra AR-verification step in the non-EU manufacturer flow that does not exist for other economic operators |
| Commission ACTOR MODULE FAQs (March 2022) | How the Actor ID/SRN is generated and issued, and the AR-must-be-registered precondition. Predates the legacy-device registration regime, so read its bare "SRN" phrasing against MDCG 2021-13 rev.1 below. |
| Commission Implementing Regulation (EU) 2021/2078, Article 3(4) | The legal basis for the signed declaration on information security responsibilities that the registration form requires |
| MDCG 2021-13 rev.1 | Actor ID vs. SRN terminology, and confirms the actor-registration obligation applies to non-EU manufacturers and their authorised representatives across legacy, custom-made and "old" device categories |
None of this changes what data belongs in a EUDAMED registration. It changes when a non-EU manufacturer is actually able to submit it. Confirming the authorised representative's SRN before starting is a short check that avoids a stalled request in the run-up to the November 2026 EUDAMED deadline.
Frequently Asked Questions
Can a non-EU manufacturer register directly in EUDAMED without an authorised representative?
No. A manufacturer not established in a Member State must designate a sole authorised representative; that designation duty is MDR Article 11. The manufacturer's own EUDAMED actor registration request then requires identifying that authorised representative by its Actor ID/SRN. The separate registration duty for both actors is MDR Article 31 and IVDR Article 28, which under the MDR applies to devices other than custom-made ones.
What does it mean that the AR must already be registered?
It means the authorised representative needs its own approved actor registration, with an SRN already issued, before the manufacturer can identify it in the manufacturer's registration form. EUDAMED's own guidance for this step states plainly that the AR must already be registered before the manufacturer submits its request. An Actor ID is only generated once a competent authority approves the registration request, so an AR whose own request is still pending has nothing the manufacturer's form can reference; a pending request carries only an application ID. If the AR has no approved EUDAMED registration at all, the manufacturer cannot complete its own request.
Who approves a non-EU manufacturer's registration, a competent authority in the manufacturer's country or the AR's?
The AR's competent authority. Because a non-EU manufacturer has no Member State of its own for EUDAMED purposes, the assessment is routed through the national competent authority responsible for the authorised representative it has named, after that AR has verified the request.
What documents does a non-EU manufacturer need to submit its registration request?
The AR's SRN or enough detail to locate it (country and name), the mandate validity dates, a summary mandate document, and a signed declaration, all uploaded as part of the registration form. The full mandate text itself is not required, only the summary.
What actually happens if the manufacturer tries to submit before the AR is registered?
The manufacturer has no valid SRN to identify its authorised representative with, so the registration request cannot be completed as a non-EU manufacturer request. The practical fix is sequencing: confirm the AR's registration is approved and its SRN issued before starting the manufacturer's own submission.
Does this AR-first sequencing apply to legacy device registration ahead of the November 27, 2026 deadline too?
Yes. The AR-first requirement is a property of EUDAMED's actor registration step itself, not of any one device category. A non-EU manufacturer registering only legacy devices before the deadline still needs its authorised representative registered in EUDAMED with an issued Actor ID/SRN before the manufacturer's own actor registration can be submitted and verified. Note that an authorised representative of only legacy devices is assigned an Actor ID that is not an SRN (MDCG 2021-13 rev.1, Q4 and Q8). What the manufacturer's form needs is the identifier, not SRN status.