The Workbench · Craft
EUDAMED is mandatory now, just not complete
This blog has already covered how an EUDAMED Single Registration Number identifies a role an economic operator plays, not the company behind it, and how MDR Article 120's legacy-device transition runs three separate deadlines, each conditioned on steps a manufacturer had to lock in back in 2024. Both essays treated EUDAMED itself as a fixed backdrop, which it wasn't. The database's own mandatory-use date moved more than once before it finally arrived this year, and the arrival turned out to be partial: four of EUDAMED's modules are mandatory today, and two of the obligations a device file carries most often, vigilance and clinical investigations, still aren't running through it at all.
A rollout keyed to an audit, not a calendar
EUDAMED's mandatory-use date used to be a single line item on every MDR transition tracker, and that line kept moving: the database was meant to go live with the regulation itself, then on a succession of later dates that never quite arrived either. Regulation (EU) 2024/1860, in force since June 2024, replaced that single date with a mechanism instead. The mandatory use of each EUDAMED module now starts six months after the European Commission declares that specific module functional, following an independent audit, and publishes a notice to that effect in the Official Journal. A tracker built around “EUDAMED: mandatory from [date]” was always going to be wrong the moment the Commission's audit found more than one module ready at a time.
Four modules crossed the line on 28 May 2026
On 27 November 2025, Commission Decision (EU) 2025/2371 declared four of EUDAMED's modules fully functional: Actor registration, UDI and Device registration, Notified Bodies and Certificates, and Market Surveillance. Six months later, on 28 May 2026, the mandatory-use clock the 2024 regulation set running for those four modules ran out. A manufacturer, authorised representative, importer, or notified body that hadn't already registered as an economic operator in EUDAMED — the same actor registration this blog has already covered as naming a role, not a company — is no longer filing that registration through whatever interim route a national authority was accepting before. EUDAMED is now where it happens.
Legacy devices get a second, later date
The 28 May 2026 date governs new registrations going forward. It isn't the deadline for devices already on the EU market before that date arrived. Regulation (EU) 2024/1860 gives those legacy devices, and the actors behind them, a further window to complete registration inside the newly mandatory modules: six more months, landing on 28 November 2026. A device registered under the old, pre-EUDAMED system, still sitting on a distributor's shelf today, isn't compliant simply because it cleared the market before May; its own record still has to land inside EUDAMED's UDI and device module before that second date closes.
Two modules are still missing, and they're not the small ones
Four modules clearing their audit doesn't mean EUDAMED is finished. The Clinical Investigations and Performance Studies module and the Vigilance and Post-Market Surveillance module hadn't been declared functional as of this writing, and neither has a confirmed mandatory-use date; industry tracking of the Commission's own working-group updates has pointed to the vigilance module landing sometime in 2027, with clinical investigations on a similar horizon. Those aren't peripheral modules. Vigilance is where a serious incident report and a field safety corrective action notice are meant to live under the Commission's own design for the system, and a device file that treats “we're EUDAMED-compliant” as one completed checkbox, rather than a status tracked module by module, has confirmed less than it thinks it has.
A serious incident still goes where it already went
A field safety notice reports the corrective action a manufacturer is taking, not a substitute account of the incident itself, and that reporting duty didn't pause for EUDAMED's own construction schedule. Until the vigilance module clears its own audit, serious incident and trend reports keep going to the national competent authority through whatever channel that authority already runs, exactly as they did before any part of EUDAMED went live. It's the same pattern this blog has already traced in Article 120's own legacy transition: an obligation already in force doesn't get lighter because the system meant to eventually carry it hasn't arrived yet. Only the venue for the four audited modules has actually changed; the vigilance duty's venue hasn't moved at all.
Where this meets the file
A EUDAMED compliance tracker needs a status field per module, not one column for the whole database: actor registration, UDI and device registration, notified body certificates, and market surveillance as live obligations with their own 28 May and 28 November 2026 dates, and vigilance and clinical investigations flagged as still running through national systems until the Commission declares otherwise. A cross-border compliance tracker built to carry that structure, alongside the launch catalog's other EU MDR templates, is previewed there now. If your program has tracked EUDAMED's rollout differently, the shelf takes that correction directly.
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