EUDAMED — the European Database on Medical Devices — becomes mandatory for all manufacturers, importers, authorised representatives, and distributors on 28 May 2026. If you are not registered after that date you cannot legally sell any product in the EU.
The SRN (Single Registration Number) is the unique identifier issued by EUDAMED after you complete actor registration. It proves your company is a recognised economic operator in the EU medical device market. From 28 May 2026, every device label and EU Declaration of Conformity must reference a valid SRN. No SRN means no legal market access — customs can reject shipments at the border.
All manufacturers of EU MDR-regulated devices, all EU Authorized Representatives, all importers bringing devices into the EU from outside, and all distributors placing devices on the EU market must register and obtain an SRN (Single Registration Number).
Competent Authorities in each member state will remove unregistered devices from the market immediately. There are no grace periods. Companies face market suspension, product recalls, and financial penalties that vary by country.
Step 1 — Appoint an EU AR. Non-EU manufacturers must appoint an EU Authorized Representative first. Your EU AR's SRN is required during your own registration.
Step 2 — Gather required documents. Before starting, collect: company registration details, GMDN codes for each device, UDI-DI numbers, intended purpose statements, device risk classification, and your EU AR agreement.
Step 3 — Create your EUDAMED account. Register via the EUDAMED portal using your EU AR's SRN as the linked entity. Select your role: Manufacturer, Importer, Authorised Representative, or Distributor.
Step 4 — Complete Actor registration and receive your SRN. EUDAMED issues your SRN within 1–3 business days of a complete submission. Incomplete submissions are rejected without notice.
Step 5 — Register each device. Link every device to your SRN and your EU AR's SRN. Enter UDI-DI, GMDN code, intended purpose, risk class, and certificate details.
NordMDR AB handles complete EUDAMED registration — from Actor registration and SRN acquisition to full device registration and annual maintenance. Contact us
NordMDR AB provides EU Authorized Representative services, CE marking and EUDAMED registration for non-EU manufacturers. Stockholm-based. Fixed fees. 5-day onboarding.
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