What is an SRN, and what does it identify?
An SRN is a Single Registration Number for an economic operator in EUDAMED. It identifies the actor, rather than a device, certificate, or individual user. The Commission’s Actor registration page explains that the concerned national competent authority assesses the request before EUDAMED generates the actor identifier.
- Actor
- The economic operator recorded in the relevant role.
- SRN
- The actor’s unique registration identifier.
- UDI-DI
- An identifier for a specific device model, variation, or version, separate from actor identity.
For planning purposes, treat actor identity as the starting point for the portfolio. A product-data spreadsheet can be prepared while a request is being assessed, but the spreadsheet does not resolve the question of which legal manufacturer should own those records. Reconcile the entity before building a submission around an assumed SRN.
Who needs to register as an actor?
The Commission lists EU and non-EU manufacturers, Authorised Representatives, importers, and system/procedure-pack producers. Determine the role of the particular legal entity, rather than assuming a commercial description such as “supplier” is sufficient. One company’s involvement in several activities may require a more careful role assessment.
A distributor-only business should not assume that importer obligations apply merely because it distributes devices. Conversely, a business described commercially as a distributor may also perform an importer role. Confirm the actual supply-chain facts and any national obligations with a qualified adviser. MDCG guidance listed by the Commission addresses additional actor-registration questions and should be checked for the relevant case.
What should you confirm before opening a request?
Confirm the exact legal entity, registered address, country, role, and responsible contact. Search existing public records using known legal names and identifiers so you can identify an existing registration before assuming one is missing. A trading name and the legal manufacturer’s name may be different.
Build a short identity pack for the person preparing the request. Include the source of each business detail and note any inconsistencies across corporate records, product documentation, certificates, or the AR agreement. This is an internal preparation recommendation; it is not a substitute for the fields or evidence required by EUDAMED or the competent authority.
If a record already exists, ask who holds authorized access and whether the actor details remain current. Starting a duplicate request is not a reliable solution to an access problem. Keep the identity question and the user-access question in separate work items, even when the same colleague owns both.
Which documents does the Commission identify?
The Commission requires actors to upload a signed declaration on information-security responsibilities. For non-EU manufacturers, it also identifies an active Authorised Representative and a mandate summary document. Use the current templates linked from the official Actor registration page.
Confirm who can sign the required declaration and prepare the current business details before requesting that signature. For a non-EU manufacturer, reconcile the manufacturer and representative identities in the mandate summary with the underlying agreement. Do not improvise a summary from a trading relationship that has not been confirmed as an active AR appointment.
The concerned authority may have relevant national instructions. Check those through the official process rather than relying on an old checklist from another country. Keep a copy of the submitted version and a named owner for questions or corrections. The site does not assert that the two document types above exhaust every case-specific requirement.
How does the actor registration flow work?
Prepare the actor request, provide the required information and documents, and follow the review process for the relevant role and competent authority. Approval by the concerned authority precedes generation of the actor identifier. A non-EU manufacturer should also confirm the representative relationship required for its registration.
Use the EUDAMED Information Centre for the current user guide and interface instructions. This page describes the preparation and accountability sequence, rather than freezing a series of screen labels that may change with a release. Follow the live guide when completing the request.
Track the request reference, submission date, current status, outstanding questions, and the person responsible for responding. These internal tracking fields help the team distinguish a request awaiting assessment from a request that needs correction. They do not create a guaranteed approval timetable.
Does actor registration automatically give every user access?
No. Actor registration and individual user access are separate. The Commission states that people intending to act on behalf of a registered actor need to submit an access request. Confirm that the colleague or provider doing the work has the appropriate authorized access for the intended activity.
Before the project starts, identify your internal owner for access and continuity. Ask how the organization will retain control if a provider changes or a colleague leaves. Use the authorized access process rather than sharing one person’s sign-in credentials. A provider’s ability to demonstrate a public record is different from having permission to maintain it.
Why can an SRN problem block device work?
Device preparation needs a reliable relationship to the correct legal manufacturer and actor record. An incorrect or unresolved entity can cause avoidable rework even when product attributes have been carefully assembled. Confirming the SRN early is therefore a practical dependency check.
The next task is to reconcile identifiers and device data. Read Basic UDI-DI explained before grouping Regulation devices, and check the legacy-device route where applicable. Do not treat obtaining an SRN as proof that a device portfolio has been registered or that its market-access conditions have been assessed.
What can you do while approval is pending?
Prepare the portfolio inventory, gather identifier evidence, and resolve internal ownership of device data. These activities can proceed without claiming the actor request is approved. Keep a clear boundary between ready-to-submit data and accepted EUDAMED records.
If the date pressure is significant, ask the relevant authority or a qualified professional how to handle the specific situation. This site cannot accelerate authority review or promise a result. Our deadline guide explains the device transition, the certificate milestone, and the legacy device registration deadline.
What evidence should you keep at handover?
Keep the approved actor identity and SRN, the current access owner, the submitted document versions, and a record of any unresolved corrections. A simple handover should allow another authorized colleague to understand what was completed without reconstructing the project from email fragments.
If you are uncertain whether the right record exists, request a free public-record check. If preparation, role assessment, or coordination needs outside help, request an independent specialist introduction. The check is a dated observation; the specialist must assess the professional work and agree its scope directly with you.