EUDAMED UDI consulting and registration

EUDAMED stopped being optional on 28 May 2026. If a device is not registered, it should not be on the EU market — and the legacy device deadline is 28 November 2026.

What changed, and when

On 27 November 2025 the Official Journal of the EU published Commission Decision (EU) 2025/2371, formally confirming that four EUDAMED modules met the functional requirements set out in the MDR and IVDR: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance. That publication started the six-month countdown written into Regulation (EU) 2024/1860.

Date	Obligation
28 May 2026	Use of the four modules becomes mandatory. New MDR/IVDR devices must be registered in the UDI/Device module before first placement on the EU market.
28 November 2026	Deadline for legacy devices and Regulation devices whose first unit was placed before 28 May 2026 and which continue to be supplied.
27 May 2027	Notified bodies must upload certificates issued before 28 May 2026.

The Clinical Investigations and Vigilance modules follow on a later date.

The deadline most companies are about to miss

A great many manufacturers read "mandatory from May" and assumed their existing catalogue was grandfathered. It is not. Legacy devices still being supplied must be registered by 28 November 2026, and legacy devices are the majority of most portfolios. The data volume is significant and the window is short.

There is a technical wrinkle here that catches people out: legacy devices use a EUDAMED-DI and EUDAMED-ID generated by the system rather than a Basic UDI-DI. Where a UDI-DI has already been assigned it must be entered, and the database allows linking a legacy device to its MDR/IVDR successor.

Prerequisites people discover too late

Actor registration and the SRN

You cannot register devices without a Single Registration Number from the Actor module. All economic operators register: manufacturers, EU authorised representatives, system and procedure pack producers, and importers.

Non-EU manufacturers must appoint an EU Authorised Representative before registering, and their actor registration must be verified by both the EAR and the relevant Competent Authority before approval. That verification takes real calendar time. Starting this in October for a November deadline is not a plan.

Basic UDI-DI architecture

The Basic UDI-DI is the EU's regulatory grouping key. It bundles devices sharing the same intended purpose, risk class, and essential design and manufacturing characteristics, and it anchors technical documentation, certificates, and EUDAMED records. It never appears on the label.

US-first companies routinely need to redesign their data model for Europe, because the American system connects records directly at the DI level and has no equivalent layer. Getting the grouping wrong means re-registering later.

Data consistency is a compliance issue

EUDAMED data must be consistent with your technical documentation, labelling, instructions for use, and notified body certificates. Inconsistencies are treated as documentation deficiencies and can delay certification or trigger surveillance action.

EUDAMED also has a public site displaying intended purpose, warnings, and CMR substances. Marketing claims that do not align with EUDAMED entries create misbranding exposure. And the manufacturer is the sole legal entity responsible for the integrity of that data — the notified body and the authorised representative do not do this for you.

Large portfolios: plan for machine-to-machine

EUDAMED supports XML-based Machine-to-Machine (M2M) submission, allowing direct integration with ERP and PLM systems. Companies with hundreds or thousands of SKUs should evaluate M2M early. Manual entry becomes the bottleneck quickly, and congestion near deadlines is a genuine risk.

Related

If the United States is also in scope, see FDA GUDID submission services. For label content and format review against MDR requirements, see UDI labeling compliance.