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EU MDR Revision: Ten Changes Coming — But the 28 November EUDAMED Deadline Won''''t Move
Two things are happening at once. On 28 November 2026, the EUDAMED registration window for legacy devices closes — after that, the question is no longer "when to register" but "how to remediate". In parallel, the MDR/IVDR revision proposal COM(2025)1023 is easing compliance burdens — but it will not apply before 2027. Urgent first, relief later.
1. Immediate: the 28 November deadline
- Under Commission Decision (EU) 2025/2371, the first four EUDAMED modules have been mandatory since 28 May 2026. Devices already placed on the market and still being supplied must be registered in the UDI/Device module by 28 November 2026 (MDR Art. 123(3)(e), IVDR Art. 113(3)(fa)). There is no second window.
- EUDAMED is publicly searchable — importers, hospitals and tendering bodies can check it. The system cross-checks Basic UDI-DI, EMDN codes, the manufacturer–authorised representative–importer SRN chain, and certificate data. If the record is missing or inconsistent, the goods do not move — a CE certificate alone does not help.
Most common mistake: a non-EU manufacturer must obtain its own SRN and link it to its authorised representative's SRN. An "account held by the AR" does not survive an authority check — get the order wrong and everything is reworked.
2. Next year: ten changes in the revision proposal
| Change | Content |
|---|---|
| Certificate validity | Fixed 5-year terms replaced by risk-based periodic review |
| Classification | Reusable surgical instruments, active implant accessories and software may be down-classified |
| Notified bodies | Harmonised assessment timelines and structured quotations |
| Clinical evidence | More flexible for well-established technologies — not a lowering of the bar |
| PRRC | Person responsible for regulatory compliance may be external or part-time (helps SMEs) |
| Repackaging/relabelling | Notified body involvement removed; supervised by national authorities |
| Post-market reporting | Longer PSUR intervals for lower-risk devices; SSCP exemption for class IIa implants |
| International reliance | Notified bodies may use assessments by FDA, TGA and comparable regulators |
| EUDAMED | Staged mandatory use and interoperability with national databases (staging already reality) |
| UDI | Issuing entities must offer fee reductions for SMEs |
These are proposal-stage provisions and may change during trilogue; the final published regulation prevails.
3. Timeline: tight now, easier later
| Date | Milestone | Status |
|---|---|---|
| 2026-11-28 | Legacy device registration in EUDAMED closes | Current law — fixed |
| 2027-05-28 | Registration deadline for certificates issued before 28 May 2026 | Current law — fixed |
| 2027 / 2028-12-31 | MDR transition ends (class III custom implantables & class IIb implantables / remaining classes) | Current law — fixed |
| 2027 / 2028 / 2029-12-31 | IVDR transition ends (class D / C / B & sterile A) | Current law — fixed |
| 2026-12-08 → 2027 Q1 → 2027 Q2-Q3 | Council position → Parliament vote → expected adoption and entry into force | Revision process |
The revision does not change any "current law" date above. Claims that it would be adopted in summer 2026 have been overtaken by the legislative process — do not postpone anything on that basis.
4. What to do now
- Register first — do not wait for the revision. The deadline does not move.
- Two-week routine: build the inventory (model, class, volume, data completeness) → close data gaps (secure an authorised representative first if you have none) → submit family by family and export snapshots → freeze, document, and sync with your AR and importers.
- Classification check: makers of reusable surgical instruments, implant accessories and software should note the potential down-classification in an internal file — but keep preparing technical documentation under the current rules.
How we can help
STATELAB CERT GmbH (North Rhine-Westphalia, Germany): EU authorised representative and Actor/SRN registration, EUDAMED submissions and legacy-device registration, Basic UDI-DI and EMDN review, MDR/IVDR technical documentation — with continuous tracking of the revision.