Economic operator registration (SRN)
Regulatory basis - MDR Art. 30 / IVDR Art. 27. All manufacturers, EU authorised representatives, importers, and (in some cases) distributors must register as economic operators in EUDAMED and receive a Single Registration Number (SRN).
Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
What is the SRN?
The Single Registration Number (SRN) is a unique identifier assigned to each economic operator registered in EUDAMED. It:
- Identifies the legal entity in all EUDAMED interactions
- Must be included on device labels (for manufacturers) and in the Declaration of Conformity
- Links the economic operator to the devices they manufacture, represent, import, or distribute
- Enables NCAs and notified bodies to identify the responsible parties for any device
Who must register and obtain an SRN?
| Economic operator | Registration obligation |
|---|---|
| Manufacturer (EU-based) | Mandatory — must register before placing any device on the EU market |
| Manufacturer (non-EU) | Must register via their EU authorised representative; the manufacturer is registered in EUDAMED as a non-EU entity |
| EU Authorised Representative | Mandatory — must register independently of the manufacturer they represent |
| Importer | Mandatory — must register before importing any device |
| Distributor | Registration required where they affix CE mark information or perform activities that affect device compliance |
Registration process — step by step
Step 1 — Access EUDAMED
Navigate to ec.europa.eu/tools/eudamed and access the Actor Registration module. An EU Login (European Commission authentication) account is required.
Step 2 — Complete the registration form
Required information:
- Legal name of the entity (exact company name as registered)
- Registered address (street, city, country)
- Type of economic operator (manufacturer, EU REP, importer, distributor)
- Contact details (email, phone)
- VAT number or equivalent business registration number
For non-EU manufacturers: registration is completed by the EU REP on the manufacturer's behalf, with the manufacturer's details entered as a separate entity.
Step 3 — Identity verification
EUDAMED applies an identity verification process before issuing an SRN. In some member states, verification involves submission of company registration documents or interaction with the national NCA.
Step 4 — SRN issued
On successful verification, EUDAMED issues the SRN. The SRN format is: {country code}-{actor type code}-{unique number} (e.g. DE-MF-000012345 for a German manufacturer).
SRN on device labels
For manufacturers: the SRN must appear on the device label (or outer packaging) for Class IIa and above under MDR / Class B and above under IVDR. For Class I (MDR) and Class A (IVDR), it is not required on the label but must be registered in EUDAMED.
For importers: the importer's name, address, and — where the importer is not easily identifiable from the existing label — the SRN must appear on the device or packaging.
Maintaining registration currency
The SRN registration must be kept up to date. Updates are required when:
- The company name or address changes
- The company changes its type of economic operator activity
- The EU REP relationship changes (non-EU manufacturer)
- The company ceases operations — the SRN registration must be deactivated
Outdated registration information is a compliance issue and may result in devices being identified as non-conformant in market surveillance checks.
One SRN per legal entity
Each legal entity receives one SRN — regardless of how many devices, product lines, or markets it operates in. The SRN identifies the company, not the product. All of that company's device registrations and vigilance reports in EUDAMED are linked to the single SRN.
Related pages
Official references
| Reference | Description |
|---|---|
| MDR Art. 30 | Economic operator registration |
| MDR Art. 31 | Summary of registration data |
| IVDR Art. 27 | IVDR equivalent |
| MDR Art. 25(5) | SRN on device labels (importer) |
| EUDAMED actor registration user guide | ec.europa.eu/tools/eudamed |