An SRN registers a role, not a company

A device manufacturer preparing its first EUDAMED submission runs into two registration steps that share a database and not much else. This blog has already touched the importer's duty to verify a device's own registration under Article 29, but that's the second of two steps, not the first. Before any device data reaches EUDAMED at all, MDR Article 31 requires the manufacturer, its authorised representative, and its importer — each one separately — to register as an actor and receive a Single Registration Number. The two articles get compressed into one mental step, “register in EUDAMED,” when they're actually a gate and what passes through it.

Article 29 and Article 31 aren't the same registration

Article 31 covers who has to exist in EUDAMED before anything else happens: before placing a device on the market, a manufacturer, authorised representative, or importer submits its own actor data — company details, contact information, the role being registered for — to the electronic system, and receives a Single Registration Number in return. Article 29 covers a different question: once an SRN exists, what device data gets tied to it, starting with the Basic UDI-DI and the core data elements Annex VI Part B requires. A manufacturer that hasn't cleared Article 31 has no SRN to attach a device registration to under Article 29 — the second step has no starting point without the first.

One legal entity, multiple roles, multiple numbers

The SRN attaches to a role, not to a company. A firm that manufactures its own devices and also imports a separate line from outside the EU performs two roles under the regulation, and Article 31 requires it to register — and receive an SRN — for each one separately. There's no single EUDAMED account that covers a company's whole business; what exists is one registration per role, and a firm that assumes its manufacturer SRN also covers work it does as an importer has assigned itself authority the registration itself never granted. The number itself reflects that structure: an SRN runs thirteen characters — a two-letter country code, an actor-type abbreviation, and a nine-digit sequence — with the role coded directly into the identifier.

A competent authority signs off; it isn't automatic

Submitting actor data doesn't itself create a working SRN. Article 31 has the competent authority of the member state where the actor is established verify the data before it obtains the number from the electronic system and issues it — the same review step that sits behind most EUDAMED modules, rather than a self-service form that activates the moment it's submitted. A manufacturer that files its Article 31 data and assumes the SRN is live the same day has skipped a step the regulation puts in someone else's hands, not its own.

Not every actor gets the same credential

Article 31 names three roles by title — manufacturer, authorised representative, importer — and those are the registrations that produce a true SRN. A system or procedure-pack producer registering under Article 22, a manufacturer dealing only in custom-made devices, and a non-EU manufacturer or authorised representative handling only legacy devices each register in EUDAMED too, but the electronic system issues them an Actor ID instead once a competent authority approves the registration. The two identifiers look alike and function alike in practice, but they're not the same credential Article 31 defines, and a file that logs every EUDAMED registration as “an SRN” has blurred a distinction the regulation itself keeps separate.

The role that never registers at all

A distributor's own duties already run through a shorter, different list than an importer's, and registration is one more place the two roles diverge. Article 31 doesn't name distributors among the actors that register, and a distributor doesn't receive an SRN or an Actor ID for that role — it verifies the conformity markings and documentation Article 14 requires without ever appearing in EUDAMED's actor registry as a party in its own right.

Where this meets the rest of the file

An EUDAMED readiness checklist that separates actor registration under Article 31 from device registration under Article 29 — and tracks which roles a single company actually performs, SRN by SRN — is previewed in the launch catalog. If your program handles this differently, the shelf takes that correction directly.