No registration, no EU market.
From November 28, 2026, use of the EUDAMED UDI/Device registration module becomes mandatory. Selling medical devices in the EU? Your actor registration, device data and labels need to be ready.
Time left until Nov 28, 2026 · 00:00 CET
Bar shows how much of 2026 has already passed before the deadline.
The deadline has passed: EUDAMED UDI/Device registration is now mandatory.
Two reasons EUDAMED registration matters.
Keep your EU market access
Under MDR and IVDR, EUDAMED registration is mandatory. No registration, no EU market.
Build trust and traceability
Every device gets a verified public identity through its UDI, so hospitals, distributors and regulators can find and trust your products.
The EUDAMED modules.
EUDAMED is made up of interconnected modules. The first ones, including actor registration and UDI/device registration, are the ones manufacturers need to act on now.
Actor registration
Register your organisation and get your Single Registration Number (SRN). Required before any device can be registered.
UDI / Device registration
Basic UDI-DI and UDI-DI records for every device, linked to your certificates and technical documentation.
Notified bodies & certificates
Certificates issued by notified bodies are linked to your device records.
Market surveillance
Information exchange between competent authorities.
Vigilance & post-market surveillance
Incident reports, field safety corrective actions and PSURs.
Clinical investigations & performance studies
Registration of investigations and studies.
How we get you registered.
As a registered EUDAMED data collector and submitter, we handle it end to end.
Open your EUDAMED account
Actor registration, SRN and user access, so you are ready to register devices.
Collect quality device data
Our structured template covers every required attribute, validated against your labels.
Assign UDI correctly
Basic UDI-DI, UDI-DI and packaging-level DIs from an EU-designated issuing entity.
Submit and confirm
Manual entry, XML bulk upload or machine-to-machine, matched to your portfolio size.
Match the labels
Compliant label design and printing so the label and the EUDAMED record say the same thing.
Keep it current
Ongoing updates when products, labels or certificates change.
Watch: the EUDAMED deadline in 60 seconds.
Why registration matters and how we help, in one short video.
EUDAMED readiness checklist
Eight boxes to tick before November 28, 2026, on one printable page.
Download the checklist (PDF)General guidance only. Timing for devices already on the EU market depends on your device type and certificate status; we confirm it for your portfolio on the call.
Don't leave EUDAMED to the last month.
Accounts, device data and labels take time to line up. Book a free 15–30 minute video consultation call. Our team will identify the gaps.
Book a Free Video ConsultationNo obligation. You get a list of the gaps we find, recommended next steps and a clear scope if you want our help.
