Legacy Device Deadline, 28 November 2026: What Manufacturers Need to Do Now

Most manufacturers are by now well aware that 28 May 2026 was an important date for EUDAMED. Less attention has gone to a second deadline just six months later: on 28 November 2026, the extended registration deadline expires for legacy devices, and for a second, easy-to-overlook group: devices already certified under MDR/IVDR but placed on the market before their module became mandatory.

Together, these two groups typically make up the larger share of a manufacturer's portfolio, next to a smaller set of genuinely new registrations. That's exactly why this deadline tends to hit manufacturers harder than the May one did.

Where does the deadline come from?

The gradual roll-out itself is enabled by Article 34 MDR, as amended by Regulation (EU) 2024/1860: modules can be confirmed functional and made mandatory one at a time. Under Article 123(3)(d) MDR and Article 113(3)(f) IVDR, obligations become mandatory six months after a module's functionality is confirmed and published in the Official Journal. Four modules (Actor Registration, UDI/Device, Notified Bodies & Certificates, and Market Surveillance) were confirmed functional on 27 November 2025, giving 28 May 2026 as the date for most obligations. Any device placed on the market from that date onward falls under this immediately and must be registered before market entry; the extended timeline below is specifically for devices already on the market before then.

For the UDI/Device module, there's a separate rule for devices already being placed on the market before that date and continuing afterward: per the MDCG's official Q&A on the gradual roll-out, registration for these is due within twelve months rather than six, which is why 28 November 2026 applies. This only affects registration timing. Whether a legacy product may still be sold at all remains governed by Article 120 MDR and Article 110 IVDR.

Legacy devices and Regulation devices: not the same thing

A legacy device was either certified by a Notified Body under the old MDD, AIMDD, or IVDD, or didn't need a certificate under those Directives but now requires Notified Body involvement for the first time under MDR/IVDR. Either way, it meets the transitional conditions of Article 120 MDR or Article 110 IVDR and is intended to stay on the EU market beyond 28 May 2026.

A Regulation device is already compliant with MDR or IVDR itself, whether through Notified Body certification or, depending on risk class, manufacturer self-declaration. It just reached the market before its module became mandatory, so it gets the same 28 November 2026 timeline, but it already has its own Basic UDI-DI and UDI-DI.

The twelve-month allowance applies to either group only if further units of the same product continue to be placed on the market on or after 28 May 2026. Products that stopped being placed on the market before that date don't need to be registered at all, unless a vigilance action requires it.

How does registration work in practice?

Device registration is the manufacturer's responsibility, carried out through the manufacturer's EUDAMED Actor account. To set one up, a non-EU manufacturer designates its Authorized Representative and submits its company information, which goes to the responsible Competent Authority for approval; the SRN is issued once that's confirmed, and only then can device registration begin.

From there, registration happens in the Device module, either manually or through bulk upload (XML or machine-to-machine), which is worth using for portfolios of several hundred products since manual entry gets impractical fast. Regulation devices are registered under their existing Basic UDI-DI and UDI-DI. Legacy devices, which don't have those numbers yet, are registered instead using identifiers generated by EUDAMED: a EUDAMED-DI in place of the Basic UDI-DI, and, wherever a UDI-DI would otherwise be needed, a EUDAMED-ID as well.

For certain devices under Notified Body certification, there's one more step: the UDI and device data only become publicly visible once the Notified Body has entered the corresponding certificate information in its own module.

Common pitfalls

• Assuming registration happens automatically. It doesn't: the responsibility sits with the manufacturer, who has to complete the original registration with correct data and keep it updated from there.
• Incomplete or outdated core data: Basic UDI-DI, EMDN codes, or certificate references that turn out to be missing or stale once you sit down to consolidate everything.
• Treating legacy and Regulation devices as identical. They share the same deadline, but not the same starting point: Regulation devices already have a Basic UDI-DI and UDI-DI to register with, while legacy devices don't and need an identifier generated by EUDAMED instead.
• Leaving large portfolios until late, risking delays from high system load close to the deadline.

What happens if the deadline is missed?

Without a valid EUDAMED registration, there's no legal basis for continuing to sell the affected product in the EU from the deadline onward, whether it's a legacy device or a Regulation device.

Frequently asked questions

Do I need to register products I no longer place on the market by November?

No. Devices that are no longer being placed on the market by then only need to be registered if a reportable incident occurs involving them.

Is my existing Basic UDI-DI sufficient?

For Regulation devices, yes: nothing new needs to be generated. Legacy devices are the exception, since they were never issued one in the first place.

What if I don't have a Basic UDI-DI?

You can generate a EUDAMED-DI in its place directly in EUDAMED, and, wherever a UDI-DI would otherwise be needed, a EUDAMED-ID as well.

If the same device is already registered as a Regulation device, does it also need registering as a legacy device?

No. If the same device, matched by UDI-DI and/or catalogue or reference number and/or trade name, is already registered as a Regulation device, no separate legacy registration is required.

Do I need to update my EUDAMED registration when I start selling in a new EU country?

Yes. Annex VI, Part A requires the device record to name the Member States where it's placed on the market (element 2.3), and, for Class IIa, IIb, and III devices, where it's made available (element 2.4). If you expand into a new country without updating that record, the data becomes incomplete, and Annex VI, Part C, Section 5.2 puts the duty to keep it current on the manufacturer. Changes that don't require a new UDI-DI must be updated within 30 days; if the change does need a new UDI-DI, that has to be registered before the modified device is placed on the market.

Does a national device database, like Germany's DMIDS, replace the need to register in EUDAMED?

No. National registers don't replace EUDAMED, and there's no automatic data transfer between the two. From 28 November 2026, EUDAMED is the sole data source; DMIDS data is kept only as an archive. A device listed nationally but not in EUDAMED can't lawfully stay on the market after that date.

Conclusion

The takeaway: know which of your products are legacy devices and which are Regulation devices, get their registrations in order well before 28 November 2026, and reach out for help early if anything about the process is unclear.