The Single Registration Number (SRN) is a one-time, permanent identifier that EUDAMED issues to each economic operator — manufacturer, authorised representative, or importer — after the Competent Authority of the Member State of establishment verifies the Annex VI Part A data submitted under MDR Article 31. You obtain an SRN by filing an actor registration through the EUDAMED actor registration module, having the Competent Authority validate the submission, and receiving the SRN the system assigns on confirmation. The SRN is then used for every downstream MDR activity that ties back to your legal entity: device registration, certificate entries, vigilance reporting, and Notified Body applications.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • The SRN is the unique identifier assigned to each economic operator by EUDAMED once the Competent Authority has verified the actor registration data required by MDR Article 31 and Annex VI Part A, Section 1.
  • MDR Article 30 is the enabling provision for the electronic system on registration of economic operators; MDR Article 31 is the substantive obligation that triggers SRN issuance; Commission Implementing Regulation (EU) 2021/2078 lays down the detailed functioning rules.
  • The SRN is permanent. It does not expire, it is not reissued when your company updates its data, and the same SRN follows the legal entity through every EUDAMED module.
  • One legal entity receives one SRN per economic-operator role. A company that acts as both manufacturer and importer holds two SRNs, one per role.
  • The SRN is what Notified Bodies, Competent Authorities, and downstream EUDAMED modules use to identify your entity. It appears on your technical documentation cover sheet, your Notified Body application, and every EUDAMED record that touches your company.

Why the SRN matters more than it looks

From the outside, an SRN looks like a bureaucratic string — a number a database hands you after a form. Founders often treat it that way. The trouble with that framing is that the SRN is the anchor point for every EUDAMED activity that follows it, and every MDR obligation that uses EUDAMED as its channel. Once your SRN exists, it is the key that Notified Bodies reference, the identifier on your certificate, the link between your legal entity and each device registered under your name, and the handle the Competent Authority uses when it contacts you about vigilance or post-market surveillance. Get the SRN wrong — registered under the wrong entity, wrong type, or wrong Member State — and every downstream record inherits the error.

This post is the deep dive on the SRN itself: what it is, who needs one, how to apply for one, how Competent Authority validation works, how the SRN is used once you have it, what your maintenance obligations are, and the mistakes founders keep making. It sits inside the EUDAMED, UDI and Registration cluster. For the pillar overview of EUDAMED see what is EUDAMED. For the step-by-step actor registration walkthrough see how to register your startup as a manufacturer in EUDAMED.

What the SRN is

The Single Registration Number is the identifier that EUDAMED assigns to an economic operator once its actor registration under MDR Article 31 has been verified by the Competent Authority of the Member State where the operator is established. The SRN is designed to be a single, stable, Union-wide handle that identifies a specific legal entity in a specific economic-operator role across every EUDAMED module and every MDR obligation that runs through EUDAMED.

The legal basis sits in three places. MDR Article 30 establishes the electronic system on registration of economic operators that the Commission sets up and manages, and requires Member States to use it to collate the information necessary to identify manufacturers, authorised representatives, and importers. MDR Article 31 is the substantive obligation on economic operators to submit that information through the actor registration module before placing a device on the Union market, using the data set in Annex VI Part A, Section 1. Article 31 also specifies the verification step by the Competent Authority and the subsequent issuance of the SRN. Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 then lays down the detailed functioning rules — registration procedures, access rights, technical support, data ownership, and information security — for how EUDAMED actually operates, including the operation of the actor registration module that issues SRNs.

Two practical properties of the SRN follow from this legal design. First, it is permanent. The SRN does not expire and is not reissued when your company updates its registered address, its PRRC, or its authorised representative. Updates flow into the existing record; the SRN stays the same. Second, it is public. Parts of the actor registration data, including the SRN, are designed to be visible on the public side of EUDAMED so that anyone — hospital procurement, investors, regulators, competitors — can look up who is behind a registered device.

Who needs an SRN

Article 31 names three categories of economic operator with an obligation to register before placing a device on the Union market (or, for authorised representatives and importers, before making a device available): manufacturers, authorised representatives, and importers. Each of these roles has its own SRN.

Manufacturers. Any legal entity that places a device on the Union market under its own name or trademark — the legal manufacturer of the device — needs an SRN as a manufacturer. For startups, this is the usual case: if your company is the legal manufacturer of the device you are bringing to market, you register as manufacturer and the SRN EUDAMED issues is the one you will use for every subsequent filing.

Authorised representatives. A non-EU manufacturer must appoint an authorised representative established in the Union under MDR Article 11. The authorised representative itself registers as an economic operator and receives its own SRN. The non-EU manufacturer also has an identity in EUDAMED, submitted through the authorised representative on its behalf, and receives an SRN as manufacturer even though it is not itself established in the Union. The authorised representative's SRN and the manufacturer's SRN are distinct.

Importers. An importer — a natural or legal person established in the Union that places a device from a third country on the Union market — registers separately under Article 31 and receives its own SRN. A company that only imports one or two devices from a non-EU partner still has the obligation; the SRN reflects the importer role.

A single legal entity can hold more than one SRN. A company that manufactures its own device and also imports another company's device into the Union is both a manufacturer and an importer for MDR purposes, and holds two SRNs — one per role. Distributors, in contrast, are not subject to the Article 31 actor registration obligation and do not receive an SRN at the Article 31 level (their obligations sit elsewhere in the Regulation).

How to apply for an SRN

The application is the actor registration filing itself. There is no separate "SRN application" step — the SRN is the output of a successful Article 31 submission. The workflow is walked step-by-step in how to register your startup as a manufacturer in EUDAMED. The condensed version is this.

First, read Annex VI Part A, Section 1 of the current consolidated MDR text and prepare every field on paper before you touch the form. Legal entity name exactly as it appears on the national business register, registered office address, legal form, national business register number, VAT number where applicable, economic-operator type, contact details of the entity (using a monitored role-based inbox, not a personal address), and the name and contact details of the PRRC under MDR Article 15.

Second, create an EU Login account for the person who will file — typically the PRRC or the regulatory lead — and access the EUDAMED actor registration module through the European Commission's EUDAMED information page.

Third, enter the data in a single sitting from your prepared document, attach the supporting documents the module asks for (business register extract, PRRC appointment, authorised representative mandate for non-EU manufacturers), confirm the Member State of establishment, and submit. The module returns a confirmation reference — keep it in your quality records.

The filing itself is the application. What comes next is validation.

The Competent Authority validation step

This is the step founders most often misunderstand. The SRN is not issued by EUDAMED automatically on submission. Under MDR Article 31(2), the Competent Authority of the Member State where the economic operator is established verifies the data submitted and then EUDAMED assigns the SRN on the basis of that verification. Validation is a legal act performed by the authority, not a system operation.

What the authority does in practice is check that the submitted data is consistent with the public business register in the Member State, that the supporting documents prove what they claim to prove, and that the economic-operator type matches the role the entity actually plays. If anything is unclear, the authority contacts the address in the submission — which is why the contact email has to be a monitored, role-based inbox. If everything is in order, the authority confirms, and EUDAMED issues the SRN.

Timelines vary by Member State. Some authorities turn clean submissions around in a few working days; others take weeks. The variation is driven by the authority's internal workload and by how clean the submission was. The Regulation does not set a fixed statutory turnaround time for this verification step. Chasing the authority rarely helps and sometimes slows things down.

A rejected or deferred submission almost always comes back for one of three reasons: a mismatch between the submitted legal name or registration number and the public business register (usually a typo), missing or incorrectly formatted supporting documents, or a selected economic-operator type that does not match the submitted data. All three are avoidable if the Annex VI Part A data was prepared properly before the form was opened.

How the SRN is used downstream in EUDAMED

Once EUDAMED issues the SRN, it becomes the identifier every downstream activity attaches to. The practical list is short, specific, and worth internalising.

Device registration under MDR Article 29. Each device you register in EUDAMED is registered under your SRN as manufacturer. The Basic UDI-DI links the device to the manufacturer through the SRN. See device registration in EUDAMED and what is a UDI.

Notified Body applications and certificates. When you submit your application to a Notified Body for conformity assessment, your SRN is part of the application package. When the Notified Body issues your certificate, the certificate entry in EUDAMED carries your SRN, so the certificate is traceable to your legal entity in every future query.

Vigilance and post-market surveillance. Serious incident reports, field safety corrective actions, and PSURs submitted under MDR Articles 87-92 attach to your SRN. Your entire post-market safety footprint in EUDAMED is indexed by SRN.

Clinical investigation sponsorship. Where you are the sponsor of a clinical investigation under MDR Articles 62-82, your SRN ties the sponsor record to your legal entity in the clinical investigations module.

Market surveillance interactions. Competent Authority inspections, non-compliance findings, and cross-Member-State enforcement coordination all reference the SRN of the economic operator concerned.

Anywhere your legal entity appears in EUDAMED, the SRN is the handle. This is the reason a sloppy actor registration is so expensive: every subsequent record inherits whatever was wrong with the first one.

Maintenance obligations

Annex VI Part A requires the registered information to be kept up to date. The SRN itself is permanent — it does not change when your data changes — but the underlying record must be updated whenever a material change makes the registered data inaccurate. The update is made through the same actor registration module, the Competent Authority re-verifies the changed data, and the record is refreshed. The SRN stays the same.

The triggers that require an update, without exception, are a change of registered office address, a change of legal form or corporate restructuring, a change of the legal entity name, a change in the PRRC (person or contact details), a change in the authorised representative for non-EU manufacturers, a change in the monitored contact details the authority uses to reach you, and a winding up of the entity. Update promptly. Do not batch changes for convenience. A written internal procedure that names these triggers belongs in your QMS and will be checked by your Notified Body during surveillance audits.

Common mistakes

  • Treating the SRN as a one-off. The SRN is permanent but the record behind it is continuous. Failing to update after an address change, a PRRC change, or a corporate restructuring leaves an inconsistent record that will surface in the next audit.
  • Registering under the wrong economic-operator type. A manufacturer who also imports a partner's device is not an "importer" for its own device — and mis-typing the role corrupts every downstream filing tied to that SRN.
  • Selecting the wrong Member State of establishment. Routes verification to the wrong authority and delays SRN issuance by weeks while the mistake is unwound.
  • Using a personal email as the contact address. The Competent Authority contacts that address directly during validation. A founder's personal inbox goes dark the moment the founder leaves, and the SRN request stalls with it.
  • Typos between the business register and the submission. A one-character mismatch on the legal name or registration number is enough to bounce the application. Every character must match the public register exactly.
  • Starting downstream work before the SRN is issued. Device registration under Article 29 and Notified Body certificate entries both depend on a valid SRN. Pre-launching them without one creates rework.
  • Confusing the SRN with the UDI or Basic UDI-DI. The SRN identifies the economic operator. The Basic UDI-DI identifies the device family. They are distinct and serve different purposes — see what is a UDI.
  • Assuming voluntary filing replaces national obligations. If the actor registration module is still voluntary for your situation under MDR Article 34, the SRN you get is useful for data discipline but does not discharge any parallel national registration obligation still in force.

The Subtract to Ship angle

The SRN is a finite deliverable with a specified data set and a single output. MDR Articles 30 and 31, plus Annex VI Part A, plus Commission Implementing Regulation (EU) 2021/2078, tell you exactly what to do. The work that belongs in your plan is exactly the work that traces to those provisions: prepare the data, file the registration, await Competent Authority validation, receive the SRN, maintain the record. Everything else — the "SRN readiness workshop," the external consultant who wants to bill three days for a filing that should take under an hour once the data is prepared, the speculative dashboards for tracking an identifier that does not change — does not belong in a resource-constrained plan. The value is in preparing Annex VI Part A cleanly the first time. That is where the subtraction dividend lives. See the Subtract to Ship framework for MDR for the full methodology.

Reality Check — Where do you stand on your SRN?

  1. Do you know which economic-operator roles your company needs to register under, and therefore how many SRNs you need to hold?
  2. Have you prepared the Annex VI Part A, Section 1 data from source documents (business register, PRRC appointment, authorised representative mandate) before opening the module?
  3. Is the contact address you plan to give the Competent Authority a monitored, role-based inbox rather than a personal one?
  4. If you are established outside the Union, is your authorised representative already appointed under Article 11, with a signed mandate ready to attach?
  5. Do you have an EU Login account for the person who will actually file?
  6. Do you have an internal procedure that names every trigger requiring an update to your actor registration record, with the SRN owner identified?
  7. Once you receive your SRN, do you know which downstream artefacts (technical documentation cover sheet, Notified Body application, device labels where relevant) need to reference it?

If you cannot answer five or more of these cleanly, stop, prepare, and come back to the module later.

Frequently Asked Questions

What is an SRN under MDR? The SRN is the Single Registration Number that EUDAMED assigns to an economic operator — manufacturer, authorised representative, or importer — once the Competent Authority of the Member State of establishment has verified the actor registration data required by MDR Article 31 and Annex VI Part A, Section 1. It is a permanent, Union-wide identifier that every downstream EUDAMED activity attaches to.

How do I get an SRN? You get an SRN by filing an actor registration through the EUDAMED actor registration module under MDR Article 31, with the Annex VI Part A, Section 1 data set. The Competent Authority of your Member State of establishment verifies the submission, and EUDAMED assigns the SRN on confirmation. There is no separate SRN application; the SRN is the output of a successful actor registration.

How long does it take to receive an SRN? Timelines vary by Member State because verification is a legal act performed by the Competent Authority, not an automated system step. Some authorities confirm clean submissions in a few working days; others take weeks. The Regulation does not set a statutory deadline for this verification. A clean submission with data that matches the public business register typically moves faster.

Does the SRN ever change? No. The SRN is permanent. When your registered data changes — address, PRRC, legal entity name, authorised representative — you update the underlying record, but the SRN itself stays the same. That permanence is deliberate and is what makes the SRN reliable as an identifier across every EUDAMED module.

Can one company have more than one SRN? Yes, if the company plays more than one economic-operator role. A company that is both the legal manufacturer of its own device and an importer of another company's device into the Union holds two SRNs — one per role. Each SRN identifies the entity in its specific role.

Do distributors need an SRN? Distributors are not subject to the Article 31 actor registration obligation in the same way as manufacturers, authorised representatives, and importers, and therefore do not receive an SRN under Article 31. Distributors have their own obligations under MDR Article 14, which sit outside the actor registration module.

Where does my SRN appear after I receive it? On your technical documentation cover sheet, in your Notified Body application, in every EUDAMED device record you submit as manufacturer, on certificate entries issued by your Notified Body, in your vigilance reports, and in any market surveillance interaction a Competent Authority has with your company. It is the identifier that ties your legal entity to everything MDR-related in EUDAMED.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 30 (electronic system on registration of economic operators), Article 31 (registration of manufacturers, authorised representatives and importers), and Annex VI Part A (information to be submitted for registration of economic operators, including Section 1 on the data set and Section 1.2 on identification data). Official Journal L 117, 5.5.2017.
  2. Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed). Official Journal L 426, 29.11.2021.
  3. European Commission, EUDAMED information page — actor registration module access, EU Login setup, user guides, and current Commission notices on module functional declarations under MDR Article 34. Readers should consult this page directly for the live operational status of the module on the day they file.

This post is part of the EUDAMED, UDI and Registration category in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. The SRN is a small identifier that controls a large amount of downstream work; the discipline that matters is preparing the Annex VI Part A data cleanly the first time, because every EUDAMED record you will ever file inherits the accuracy of that first submission.