EUDAMED — the European database that has been optional since MDR came into force — becomes mandatory on a staged schedule through 2026, set by Commission Implementing Decision (EU) 2025/2371. The date is not the hard part. The hard part is that mandatory use assumes you already hold clean actor, UDI, and device data — and most manufacturers don't, especially for legacy devices.

What actually changed

For years, EUDAMED's modules were available but voluntary, so many manufacturers registered opportunistically or not at all. The 2025 decision converts that into an obligation on defined dates, module by module. It does not change what the data must contain — it changes when incomplete data stops being tolerable. Reconciling this to your wider EU MDR & IVDR strategy is what keeps registration from becoming a standalone fire drill.

6
EUDAMED modules, each with its own mandatory-use date.
SRN
The Single Registration Number gates everything — no actor record, no submissions.
2026
The year mandatory use phases in under Decision (EU) 2025/2371.

Which modules go mandatory, and when

The sequence matters more than any single date, because each module depends on the one before it:

  1. Actor registration. You cannot do anything else until your SRN is issued and your actor data is correct.
  2. UDI & Device registration. Basic UDI-DI and UDI-DI records for every device, reconciled to labeling and the technical file.
  3. Notified Body & Certificates. Certificate data flows from your NB; errors here surface late and are painful to correct.
  4. Vigilance & post-market surveillance. The modules that connect to your live quality system and your post-market surveillance obligations.
The deadline is not the risk. The risk is discovering, the week it becomes mandatory, that your legacy device data was never assembled at all. The practical implication for 2026

The readiness work that takes longest

Actor registration is quick. UDI and device data is not — particularly for legacy MDD/AIMDD devices still on the market during the MDR transition, whose records were often never built to EUDAMED's structure. That reconciliation is the work to start now. For a worked example of where device teams get the surrounding processes wrong, see how PMS ties into EUDAMED.

A 90-day EUDAMED readiness sequence
  1. Confirm your actor registration. Verify the SRN is issued and actor data is current before the Actor module locks in.
  2. Assemble and reconcile UDI data. Build Basic UDI-DI and UDI-DI records for every device and reconcile them to the technical documentation.
  3. Register devices, including legacy. Compile current and legacy device data — the legacy set is the most common gap and takes the longest.
  4. Close the loop to vigilance and PMS. Align surveillance processes so the later modules need no rework.

None of this requires heroics. It requires starting before the date, treating EUDAMED as a data-readiness program tied to your technical documentation rather than a portal to fill in at the last minute. The manufacturers who struggle in 2026 will be the ones who waited for the module to become mandatory before checking whether their data existed.

Frequently asked questions

When does EUDAMED become mandatory?

Mandatory use is staged through 2026 by Commission Implementing Decision (EU) 2025/2371, module by module rather than in a single switch. The Actor, UDI/Device, and Notified Body/Certificate modules are the first to become obligatory, with the remaining modules following on their own dates.

Which EUDAMED modules are required first?

Actor registration (your SRN), then UDI and Device registration, then the Notified Body and Certificates module. Vigilance and post-market surveillance follow. Because each has its own date, readiness is a sequence, not a single deadline.

Do legacy MDD/AIMDD devices still need to be registered?

Yes. Devices placed on the market under the old directives during the MDR transition still require registration once the Device module is mandatory. Legacy devices are a frequent gap because their data was never assembled for EUDAMED.

Sources & further reading

  1. European Commission. Commission Implementing Decision (EU) 2025/2371 on the functioning of EUDAMED. eur-lex.europa.eu
  2. European Commission. EUDAMED — overview, modules, and timeline. health.ec.europa.eu
  3. MDCG guidance on actor, UDI, and device registration. health.ec.europa.eu

This article is provided for general informational purposes and reflects the regulatory landscape as of July 2026. It is not legal or regulatory advice. Confirm current EUDAMED requirements and dates with the European Commission or qualified counsel before acting.