EUDAMED’s Next Deadline Is Narrower Than It Looks

Mandatory EUDAMED use began on 28 May 2026. The next date on everyone's slide deck is late November — and it is being described, almost everywhere, as the day every device already on the European market must be registered. That is not what the provision says.

What actually happened on 28 May

On 26 November 2025 the Commission adopted Decision (EU) 2025/2371, declaring that four EUDAMED modules meet their functional specifications. It was published in the Official Journal the following day. Under the transitional provisions inserted into the MDR and IVDR by Regulation (EU) 2024/1860, publication of that notice starts a six-month clock: the obligations relating to the electronic systems “shall apply from the date corresponding to 6 months from the date of publication of the notice”.

That date was 28 May 2026. From it, four modules are no longer voluntary: Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance. Two modules — Post-Market Surveillance and Vigilance, and Clinical Investigation and Performance Studies — are not in the set, and remain under development.

The clause everyone is compressing

The second deadline comes from MDR Article 123(3)(e). It requires that, “no later than 12 months from the date of publication of the notice”, manufacturers ensure the information to be entered in EUDAMED is entered — including for devices undergoing conformity assessment under Article 52, and devices placed on the market under the Article 120 transitional provisions, unless already registered.

Then comes the qualifier that the summaries tend to drop. The obligation applies to those devices “provided that those devices are also placed on the market from 6 months from the date of publication of that notice”. Six months from publication is 28 May 2026. On the face of it, the duty attaches to devices that are still being placed on the market on or after that date — not to every device that has ever been supplied into the Union.

“…provided that those devices are also placed on the market from 6 months from the date of publication of that notice.” MDR Article 123(3)(e), as amended by Regulation (EU) 2024/1860

The distinction is not academic. A manufacturer with a discontinued legacy line still sitting in a distributor's warehouse reads “all legacy devices by November” and starts assembling Basic UDI-DI records for products it no longer places on the market. A manufacturer that is still shipping those devices has the obligation, and may be reading the same summary with less urgency than it deserves. The two are being told the same thing.

Two regulations, two clocks, one week

The MDR and IVDR do not use the same starting gun. The MDR counts 12 months from publication of the notice. The IVDR, at Article 113(3)(fa), counts “no later than 6 months from the date set out in point (f)” — that is, six months from the date mandatory use began, not from the notice. Both arrive in late November 2026, which is why they are usually collapsed into a single bullet.

• MDR: 12 months from publication of the notice (27 November 2025).
• IVDR: 6 months from the date mandatory use began (28 May 2026).
• Both: qualified by the same construction — the devices must also be placed on the market from the mandatory date.

What is not settled

Two things. First, the Commission's announcement of mandatory use does not mention a legacy registration deadline at all; the date circulating in the trade press is derived from the regulation, not quoted from the Commission. Second, the reading above is the natural reading of the words, but the MDCG's Q&A on the EUDAMED roll-out is the document that would resolve how the proviso is applied in practice, and it is the one worth reading before a compliance plan is built on either interpretation.

We are not going to tell you the summaries are wrong. We are telling you that the clause is narrower than the summaries, that the difference decides who has work to do before November, and that the authority to settle it is the guidance rather than any outlet — including this one.