EUDAMED Deadlines in 2026: What’s Actually Mandatory, and When
10 September 2026
If you’ve seen conflicting deadlines mentioned for EUDAMED, it’s because there isn’t one deadline — there are two, for two different kinds of devices, and they’re easy to mix up.
MDR devices: 28 May 2026
UDI registration in EUDAMED became mandatory for MDR devices on 28 May 2026 — the same date the four core EUDAMED modules (actor registration, UDI/device, certificates, market surveillance) became mandatory across the board. If your devices fall under Regulation (EU) 2017/745, this date has already passed.
Legacy MDD/AIMDD devices: 27 November 2026
Devices still under the old Medical Devices Directive or Active Implantable Medical Devices Directive get a separate, later deadline: 27 November 2026. This is the one that’s still ahead for most manufacturers carrying legacy catalogue items — and the one worth checking your own data against now, not in November.
What "mandatory" actually means
These aren’t soft target dates. Once a module or device category is mandatory, EUDAMED expects the registration to already exist — there’s no grace window built into the system itself. Missing it isn’t a paperwork delay; it can mean losing market access for that device in the EU.
What’s still ahead
Vigilance & Post-Market Surveillance and Clinical Investigations are separate modules, still pending activation as of this writing, expected sometime in 2027. When each goes live, it becomes mandatory on a set date the same way the first four modules did — worth planning for now rather than being caught by it later.
If you’re not sure where your own catalogue stands against either date, that’s worth checking today rather than the week before it’s due.