EUDAMED mandatory registration is coming on 28 May 2026. NordMDR AB handles the complete process — Actor registration, SRN acquisition, device registration and UDI entries — for manufacturers from anywhere outside the EU. Based in Stockholm, Sweden.
EUDAMED is the European Database on Medical Devices — the EU's central registry for all devices, manufacturers, importers, distributors and authorised representatives. From 28 May 2026, registration is mandatory. Without it, your products cannot legally be sold in any EU member state.
Every economic operator must be registered and hold a unique SRN (Single Registration Number). Non-EU manufacturers cannot register directly — they must first appoint an EU Authorized Representative who registers on their behalf.
All manufacturers, EU Authorized Representatives, importers and distributors placing medical devices on the EU market must register in EUDAMED and obtain an SRN.
After this date, Competent Authorities can immediately remove unregistered devices from the EU market. No grace periods. No exceptions.
Actor registration, SRN acquisition, device registration, UDI database entries and annual maintenance — complete EUDAMED management.
Complete EUDAMED registration typically takes 4-8 weeks. Starting now gives you comfortable margin before the May 2026 mandatory date.
Non-EU manufacturers must do this first. Your EU AR registers in EUDAMED on your behalf and links their SRN to yours.
GMDN codes, UDI details, intended purpose, risk classification and Declaration of Conformity for each device.
Register your company in EUDAMED to receive your SRN (Single Registration Number) — your unique EU market identifier.
Register each device in EUDAMED and link it to both your manufacturer SRN and your EU AR's SRN.
EUDAMED registration requires annual updates. NordMDR AB handles ongoing maintenance so you stay compliant.
NordMDR AB handles the complete process. Sweden-based. Fixed fees. Fast turnaround.
Get Free EUDAMED Assessment →EUDAMED is the European Database on Medical Devices — the EU central registry for all devices, manufacturers, importers, distributors and authorised representatives. From 28 May 2026 registration is mandatory for all economic operators.
An SRN (Single Registration Number) is obtained by registering your company as an Actor in EUDAMED. Non-EU manufacturers must do this through their EU Authorized Representative. NordMDR AB handles the complete SRN registration process.
All manufacturers, EU Authorized Representatives, importers and distributors placing medical devices on the EU market must register. Non-EU manufacturers cannot register directly — they must appoint an EU AR first.
Complete EUDAMED registration typically takes 4-8 weeks. NordMDR AB starts the process within 5 business days of receiving your documentation. Do not wait — the 28 May 2026 deadline is approaching.