What MDR Article 31 Requires
Before placing a device, other than a custom-made device, on the market, manufacturers, authorised representatives and importers must register in EUDAMED under MDR Article 31, provided they have not already registered. That much sets out who has to register and when. The article's second paragraph says what the competent authority does next: after having verified the data submitted under the first paragraph, the competent authority obtains a single registration number (SRN) from EUDAMED and issues it to the manufacturer, the authorised representative or the importer.
What the paragraph leaves out matters as much as what it says. SRN issuance is conditioned on verification being complete, but the text attaches no number of days or weeks to that verification. The competent authority obtains the SRN from EUDAMED and issues it, a distinction the regulation draws itself, and the duration of the step in between is not addressed. The clocks the article does set fall on the economic operator. Paragraph 4 gives one week to update changed data, and paragraph 5 requires confirming the data not later than one year after submission and every second year after that.
What the Commission's Guidance Says About Timing
The regulation states no deadline for competent-authority verification, and the Commission's own guidance does not supply one either. The Commission's Actor Module FAQ (March 2022) puts the question directly: "Is there an agreed timeline between Member States / Competent Authorities to complete the validation of the submitted Actor registration applications?" The Commission's answer: "No, there is no agreed timeline for validation, except that it should be done within the best delay."
That FAQ is from March 2022 and predates the Actor module's mandatory-use date of May 28, 2026. The Commission's current Actor module user guide for economic operators, Production v2.27.0 (2026), walks through the registration workflow screen by screen and does not mention a processing time, a deadline or a service target anywhere in its text.
None of the three sources states a duration. MDR Article 31's second paragraph conditions the SRN on completed verification without a stated time limit, the Commission's FAQ says outright there is no agreed timeline and the Commission's current user guide never raises the question of duration. Neither the regulation nor the Commission documents gives a figure for how long EUDAMED actor registration takes.
Submit, Assess, Three Outcomes
The Commission's own process diagram for actor registration (for every economic operator except a non-EU manufacturer, which has an extra step described below) shows a single assessment step with three possible outcomes. The diagram covers EU manufacturers, authorised representatives, importers and system/procedure pack producers together. MDR Article 31 names only the first three, and the user guide says whether an actor receives an Actor ID or an SRN depends on its role, so the table below uses the diagram's own term, Actor ID/SRN.
| Outcome | What happens |
|---|---|
| Request approved | The Actor ID/SRN is generated by EUDAMED and issued by the competent authority; EUDAMED notifies the actor by email |
| Corrections requested | The actor edits and resubmits the registration request, which goes back to the competent authority for assessment |
| Final refusal | The request is refused outright, with no further resubmission step shown on the diagram |
The Commission's Actor Module FAQ (Q2.11) adds a documented duplicate check. EUDAMED normally triggers a duplicate warning, first for the requester and then for the potential authorised representative verifier and the competent authority assessor. The competent authority has to look into those requests, since EUDAMED itself performs no assessment.
What Determines How Long It Takes
Neither the regulation nor the Commission documents above publishes a processing-time target to plan against, so the more useful question is what those documents say about the assessment itself:
- A duplicate-looking entry. The FAQ (Q2.4 and Q2.11) describes EUDAMED normally triggering a duplicate warning for the requester, then for the potential authorised representative verifier and the competent authority assessor, which has to look into the request and decides whether to reject it on that ground.
- A corrections-requested outcome. The user guide states that incorrect or incomplete requests will not be validated and no Actor ID/SRN is generated until a complete and correct request has been provided and validated, with no stated duration for that second pass.
- The non-EU manufacturer's extra step. A non-EU manufacturer's request is verified by its named authorised representative before a competent authority ever assesses it, and the user guide says that authorised representative must already be registered in EUDAMED before the manufacturer can submit its request. See EUDAMED for Non-EU Manufacturers for why that means an issued Actor ID/SRN and for the full sequencing.
None of this adds up to a number of days or weeks, because neither the regulation nor the Commission documents above gives one. One thing is documented as possibly speeding it up. The FAQ (Q2.8) says the EORI number, national trade registry ID and VAT fields are optional, though a competent authority could require them depending on country, actor role and location, that they are part of the duplicate check and that providing them might speed up the competent authority's assessment. A complete, correct request is a precondition rather than a speed-up, since the user guide says incorrect or incomplete requests are not validated.
Primary Sources
| Document | Covers |
|---|---|
| MDR Article 31 (consolidated text) | The registration duty (paragraph 1) and the verification-then-SRN sequence in paragraph 2, which states no time limit |
| IVDR Article 28 (consolidated text) | The IVDR registration duty, without MDR's custom-made carve-out, and the same verification-then-SRN sequence in its paragraph 2 |
| Commission Actor Module FAQs (March 2022, v1.8) | Q2.12: no agreed timeline between competent authorities for validation. Q2.4 and Q2.11: the duplicate check. Q2.8: the optional identifier fields that might speed up assessment |
| EUDAMED User Guide, Actor Module for Economic Operators (Production v2.27.0, 2026) | The current, full description of the registration workflow; checked for and found to contain no processing-time or deadline language |
| EUDAMED Actor Registration Request Process (European Commission, DG Health and Food Safety) | The Commission's own process diagram showing the three assessment outcomes |
The regulation conditions the SRN on completed verification, not on a deadline, and the Commission's FAQ and current user guide do not supply one either. Providing the optional EORI, trade registry and VAT fields, submitting a complete request the first time and, for a non-EU manufacturer, confirming the authorised representative's registration before submitting are the steps the Commission's documents address, which matters while the November 27, 2026 EUDAMED deadline approaches.
Frequently Asked Questions
Does EU law set a deadline for EUDAMED actor registration?
Not for the competent authority's side of it. MDR Article 31's first paragraph sets the operator's timing: register before placing a device, other than a custom-made device, on the market, and before applying to a notified body where one is involved. The second paragraph conditions SRN issuance on the competent authority having verified the data submitted under the article's first paragraph, but it does not attach a number of days or weeks to how long that verification may take.
Does the Commission publish any timeline for actor registration?
No. The Commission's own Actor Module FAQ states there is no agreed timeline between competent authorities for completing validation of a submitted request, only that it should happen within the best delay. The current Actor module user guide for economic operators does not mention a processing time, a deadline or a service target anywhere in its text either.
What happens if my registration request is sent back for correction?
EUDAMED's own process diagram shows three outcomes once a request is assessed: approved, with the Actor ID/SRN issued; corrections requested; or final refusal. A corrections-requested outcome means editing and resubmitting the request. Neither the diagram nor the FAQ states how long that second cycle itself takes.
Does MDR Article 31 apply the same way to IVDR registrations?
IVDR Article 28 imposes the same registration duty on manufacturers, authorised representatives and importers, but without MDR's custom-made carve-out. Its second paragraph has the same structure as the second paragraph of MDR Article 31. After verifying the data, the competent authority obtains an SRN from the IVDR's electronic registration system and issues it, with no time limit stated.
Does registering as a non-EU manufacturer follow the same timeline?
Non-EU manufacturer registration has an additional documented step before competent-authority assessment: the manufacturer's named authorised representative must already be registered and verifies the request first. That extra step, like the rest of the process described here, is not tied in Commission documentation to a measured duration.