EUDAMED Actor Registration and SRN: What Non-EU Manufacturers Miss

You plan to register your devices in EUDAMED before 27 November 2026. The device data is ready. Then the team discovers that the Single Registration Number (SRN) is not active, that the authorised representative mandate in EUDAMED is out of date, or that nobody in the company can still log in. Device registration cannot start until the EUDAMED Actor registration is in order.

The short answer: under Article 31 of Regulation (EU) 2017/745, manufacturers, authorised representatives and importers must register as actors in EUDAMED and receive an SRN from the competent authority. Non-EU manufacturers also need an active authorised representative who is already registered in EUDAMED. After registration, the data must be updated within one week of any change and confirmed every two years.

At a glance

Why does the Actor registration come before device registration?

Article 31(1) of Regulation (EU) 2017/745 requires manufacturers, authorised representatives and importers to submit their registration information to EUDAMED before placing a device on the market. When the conformity assessment involves a notified body, this information must be provided before the application to the notified body.

The competent authority then verifies the data and issues the SRN (Article 31(2)). The manufacturer uses the SRN when applying to a notified body and to access EUDAMED for device registration (Article 31(3)). In other words, every device record in EUDAMED depends on a valid Actor registration.

This is why the November deadline is, in practice, an Actor deadline first. If you have not read it yet, our article on the EUDAMED deadline of 27 November 2026 explains which devices are affected and the full plan for the final weeks.

What does a non-EU manufacturer need before submitting the request?

The European Commission and the EUDAMED help pages list these elements for non-EU manufacturers:

• An active authorised representative. The authorised representative must already be registered in EUDAMED before you can submit your request.
• The mandate details. You enter the start and end dates of the mandate and upload a mandate summary document as a PDF of up to 10 MB. The full mandate is not required, and the summary is not public.
• A signed declaration on information security responsibilities. The Commission requires every actor to upload this declaration, using the template it provides.
• Consistent company data. Legal name, address and contact details must match your other regulatory documents.

The order of the checks matters. Your authorised representative verifies your request first. Only then does the request reach the competent authority, which validates it. If the request is incomplete or incorrect, it goes back for correction, and no SRN is issued until a complete request is validated.

In practice

Consider a manufacturer based outside the EU that changed its authorised representative last year. The new mandate was signed, as Article 12 of the MDR requires, but nobody updated the Actor data in EUDAMED. The device data is ready for registration. Before the team can use it, the Actor data must be corrected and checked again by the new authorised representative and the competent authority. A task that looked like one afternoon now depends on two other organisations.

How long does it take to get an SRN?

The official documents do not set a fixed time. The Commission’s Actor module Q&A states that there is no agreed timeline for validation. EUDAMED generates the SRN only after the competent authority has assessed and approved the request. For non-EU manufacturers, the authorised representative also needs time to verify the request first.

Our recommendation is to treat the SRN as the item with the longest and least predictable lead time. Start or check it before you prepare any device data.

Who in your company can access EUDAMED?

Access to EUDAMED is managed through user profiles. According to the EUDAMED user guide for economic operators:

• Every user needs an EU Login account to access EUDAMED, including the LAA.
• The Local Actor Administrator (LAA) is the highest profile. The LAA manages the actor details, the contact details and the access requests of other users.
• The Local User Administrator (LUA) validates access requests and manages users.
• The guide calls it good practice to have at least two LAAs for each actor, as a fail-safe if one is unavailable.
• If the last or only LAA leaves the organisation or loses their EUDAMED login, the guide says to contact EUDAMED support.

Is this you?

• You do not know who in your company holds the LAA profile today.
• The person who created your Actor registration has left the company.
• Your authorised representative changed, but EUDAMED still shows the old mandate.
• Your SRN is not recorded anywhere in your quality management system.

If you answered yes to any of these, check your Actor registration before you move to device registration.

What must you keep up to date after registration?

Registration is not a one-time task. Article 31 of the MDR sets two ongoing obligations for every economic operator:

1. Update within one week. Within one week of any change to the registration information, the economic operator must update the data in EUDAMED (Article 31(4)).
2. Confirm every two years. Not later than one year after the first submission, and every second year after that, the economic operator must confirm that the data is accurate (Article 31(5)). If this does not happen within six months of those deadlines, any Member State may take appropriate corrective measures within its territory until the economic operator complies.

Sobel’s regulatory interpretation is that these obligations work best as a quality system process, not as a reminder in one person’s calendar. Assign an owner, record the next confirmation date and link any change of address, legal name or authorised representative to an update in EUDAMED.

What to do now

1. Confirm that your Actor registration is approved and that your SRN is active.
2. Check who holds the LAA profile. If only one person does, add a second LAA.
3. Non-EU manufacturers: confirm with your authorised representative that the mandate dates and the mandate summary in EUDAMED are current.
4. Record the SRN, the LAA holders and the next confirmation date in your quality management system.
5. Move on to device registration, following the plan in our article on the 27 November 2026 deadline.

How Sobel can help

Sobel Consult acts as EU Authorised Representative for manufacturers outside the European Union and supports the full EUDAMED process: Actor registration, mandate documentation, device data preparation and device registration.

Frequently asked questions

Do distributors need to register as actors in EUDAMED?

No. The Commission Q&A states that distributors are not required to register in EUDAMED. They may still need to register at national level in the Member States where they make devices available.

Does each device need its own Actor registration?

No. The Actor registration is for the company. Article 31(1) applies only if the economic operator has not already registered. The same SRN is then used for all device registrations of that company.

Do we need a separate SRN if we are both manufacturer and importer?

Yes. The Commission’s Actor module Q&A states that a separate registration request is required for each actor role. Each role, for example manufacturer and importer, receives its own SRN.

Is the mandate summary document public?

No. According to the EUDAMED help pages, the mandate summary is not publicly available. The full mandate text is not required for the registration request.

What happens if we do not confirm our data every two years?

Article 31(5) of the MDR allows any Member State to take appropriate corrective measures within its territory if the confirmation is more than six months late, until the economic operator complies.

What if the only person with administrator access has left the company?

The EUDAMED user guide says to contact EUDAMED support when the last or only Local Actor Administrator leaves the organisation or loses their login. To avoid this situation, the guide recommends at least two LAAs per actor.

Official sources

• Regulation (EU) 2017/745 (consolidated text) – Articles 11, 12 and 31
• European Commission – Actor registration module
• EUDAMED help – Register as a non-EU manufacturer
• EUDAMED user guide – Actor module for economic operators
• European Commission – Q&A on the gradual roll-out of Eudamed
• European Commission – Actor module FAQs

This article provides general information based on official EU documents available on the date of publication. It does not replace an assessment of your specific situation.