Need to register in EUDAMED? We handle actor and device registration for manufacturers, EU Reps and importers — compliant from day one. Bulk portfolio upload available.
Submit your current certificate status below. Our Stockholm compliance team will review your application and respond within 2 hours to map which post-deadline transition pathways apply to your devices.
✓ Stockholm-Based Advisory Team
✓ GDPR-Compliant Data Routing
✓ Active Cross-Border Swiss (CH-REP) & EU Coverage
Commercial service
Typical onboarding: actor/SRN in 1–3 weeks · bulk device upload scoped by portfolio size · fixed-fee quote before work starts.
Get EUDAMED Registration Quote →EUDAMED — the European Database on Medical Devices — is now in its post-May 2026 enforcement phase. The May 2026 EUDAMED milestone has passed. Manufacturers must immediately assess how active post-deadline transition pathways apply to their legacy vs. new device inventories to prevent supply chain freezes. For integrated support, see our EU MDR consulting services — or our step-by-step MDR UDI how-to guide for device identifier setup.
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. Speak with a Stockholm-based MDR consultant (2-hour response)
While processing queues vary based on competent authority response speeds, NordMDR packages client validation dossiers within 48 business hours to accelerate actor registration approval. Our Stockholm team responds to urgent intakes within 2 hours to scope your post-deadline pathway.
EUDAMED registration means registering as an economic operator (manufacturer, EU Authorised Representative, importer, or distributor) in the European Database on Medical Devices and obtaining an SRN (Single Registration Number), then linking each device to your profile. It is required for legal EU market access under the post-May 2026 enforcement framework.
Most non-EU manufacturers benefit from integrated EU MDR consulting and EUDAMED support: you need correct device classification, a valid EU AR agreement, complete actor dossiers, and UDI/GMDN data before EUDAMED accepts your submission. NordMDR provides both from a single Stockholm-based engagement.
EU MDR consulting typically covers gap analysis against Annex II/III, clinical evaluation support, Notified Body readiness, EU Authorized Representative appointment, EUDAMED actor and device registration, labelling review, and post-market surveillance planning under Regulation (EU) 2017/745.
Yes. We help manufacturers assess how active post-deadline transition pathways apply to legacy vs. new device inventories, then execute actor registration, SRN issuance, and device linking with prioritized dossier packaging.
NordMDR AB provides EU Authorized Representative services, CE marking and EUDAMED registration for non-EU manufacturers. Stockholm-based. Fixed fees. 2-hour response on urgent intakes.
Speak with a Stockholm-based MDR consultant (2-hour response)