28 November 2026 EUDAMED deadline: legacy devices and models still placed on the EU market must be registered

Core update

The European Union has split mandatory use of EUDAMED into two clocks. From 28 May 2026, four modules become mandatory: Actor, UDI/Device, Notified Bodies and Certificates, and Market Surveillance. 28 November 2026 is the deadline for existing devices to be registered in the UDI/Device module. This batch covers legacy devices and MDR/IVDR devices whose first placement on the market occurred before 28 May 2026 and for which individual units continue to be placed on the market thereafter. One registration covers all individual units under the same UDI-DI. Models that are no longer placed on the market are in principle exempt from registration, but if a serious incident or field safety corrective action occurs, the device must first be registered before a report can be submitted. A legacy device may be exempt if the 'same device' has already been registered as a Regulation device; the assessment depends on the correspondence between UDI-DI, model and trade name.

Published: 3 November 2026, 19:52. Category: UDI, labelling and post-market surveillance.

Two mandatory-use clocks

Regulation (EU) 2024/1860 was adopted on 13 June 2024 and entered into force on 9 July 2024. It changed EUDAMED from a single go-live to a module-by-module rollout. On 26 November 2025, the European Commission adopted Commission Decision (EU) 2025/2371, declaring that the functionality and functional specifications of the first four modules met the applicable requirements. The decision was published in the Official Journal of the EU on 27 November 2025. Under the transitional provisions of Regulation (EU) 2024/1860, there is a six-month transition period after publication. As a result, the Actor, UDI/Device, Notified Bodies and Certificates, and Market Surveillance modules become mandatory from 28 May 2026.

Which devices fall within the 28 November 2026 deadline

The second clock runs from the same publication date. In its guidance on the UDI/Device module and its transition timeline, the Commission states that if the first individual unit of a device was placed on the EU market before the mandatory-use date, and other individual units of the same model continue to be placed on the market on or after 28 May 2026, the device must be registered within 12 months of publication in the Official Journal — that is, before 28 November 2026. Registration is by UDI-DI. One registration covers all individual units under the same UDI-DI; unit-level registration by batch number or serial number is not required.

Devices first placed on the market on or after 28 May 2026

The reverse situation must also be distinguished. Devices first placed on the market on or after 28 May 2026 have no grace period: they must be registered before the first unit is placed on the market. By contrast, models for which no individual unit is placed on the market after the mandatory-use date are in principle not required to be registered. This is not a permanent exemption. If a serious incident, field safety corrective action or trend report — or another post-market surveillance action — occurs for that device, the manufacturer must still first register it in the UDI/Device module before submitting a report in the Vigilance module. Manufacturers should not rush to delete the device master data for discontinued models from their records.

Legacy-device exemption: the 'same device' test

There is an exemption route for legacy devices, but the threshold is detailed. According to the Commission Q&A, a legacy device does not need to be registered again if the 'same device' has already been registered as an MDR/IVDR Regulation device. 'Same device' means that the two are identical in identification terms — for example, the same UDI-DI, or shared model, catalogue number, trade name or other information derived from common characteristics. If the Regulation-device version has been changed and assigned a new UDI-DI, it is no longer the same device, and the legacy version must be registered separately. Manufacturers should keep a written record of this assessment rather than relying on an oral conclusion.

Devices outside the UDI/Device module

Several categories are explicitly outside this module. Custom-made devices cannot be registered. 'Old devices' described in MDCG 2021-25 Rev.1 and MDCG 2022-8 also cannot be registered. When a manufacturer incident report or field safety corrective action occurs for such devices, a limited device data set is instead submitted to the Vigilance module. Actor registration is a technical prerequisite for device registration: manufacturers, importers, EU authorised representatives, and system and procedure pack assemblers must first be registered in the Actor module before devices can be linked.

Relationship with national registration

The relationship between national registration and EUDAMED has also changed. The Commission Q&A explains that national registration requirements continue to apply until the UDI/Device module becomes mandatory. After mandatory use, if the same device is registered both in a national system and in EUDAMED, the existing EUDAMED entry becomes the registration required by the Regulation. For companies selling in several Member States, this reduces the need for duplicate national data entry but increases the requirement for data consistency.

Separate deadlines for contact lenses and eyewear

Two product groups have separate deadlines. Contact lenses with a primary UDI-DI have the same registration deadline of 28 November 2026. Spectacle lenses, frames and ready-to-wear reading glasses have a later deadline of 1 November 2028. These dates come from public guidance issued by the Swedish Medical Products Agency and are consistent with the Commission's transition arrangements.

Portal maintenance on 3 November 2026

For same-day planning, the EUDAMED portal has two maintenance windows on 3 November 2026: 08:00–08:35 and 12:00–15:55 Central European Time. The system may be unavailable during these periods. Companies completing late registrations before the deadline should avoid these windows when scheduling work.

Sources

• Official Journal of the EU — Regulation (EU) 2024/1860 (EUR-Lex), 9 July 2024: https://eur-lex.europa.eu/eli/reg/2024/1860/oj
• European Commission — EUDAMED overview, including Commission Decision (EU) 2025/2371 and the mandatory-use dates for the four modules: https://health.ec.europa.eu/medical-devices-eudamed/overview_en
• European Commission — Q&A on the gradual roll-out of EUDAMED, explaining the 12-month registration deadline and the 'same device' assessment: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=eudamed-qa_en.pdf
• European Commission — Transition period: legacy and Regulation devices placed on the market before the mandatory use, showing the 28 November 2026 registration deadline: https://health.ec.europa.eu/document/download/3bb39d28-dcaa-4907-9ea9-ea89cee091c0_en?filename=md_eudamed_tp-leg-reg-devices_en.pdf
• Läkemedelsverket (Swedish Medical Products Agency) — Registration in Eudamed, including deadlines for contact lenses and eyewear: https://www.lakemedelsverket.se/en/medical-devices/manufacture/registration/registration-in-eudamed (source list date: 9 October 2025; the article's source note also cites a 10 June 2026 update)

Source verification and applicability

Verification scope and access date: The five materials above were checked on 3 November 2026 against the publication date of the Commission Decision, the six-month and 12-month deadlines, the scope of registration by UDI-DI, the exemptions and excluded device categories, and the announced date of the portal maintenance window. Dates and provisions in this article are taken from the Chinese-language paraphrase of the official texts listed above.

Applicability: This article interprets public regulatory information and the official timetable. It does not constitute a conclusion or commitment for any specific product, company or registration application. Whether a device falls within the scope of existing-device registration, and whether it constitutes the 'same device', depends on its actual UDI-DI, model, trade name and placement records. The official original texts and the views of the competent authorities should prevail. Information may change with subsequent official updates.

AIMEILI regulatory interpretation

Regulatory interpretation

The 28 November 2026 deadline is not limited to classic 'legacy devices'. It captures any MDR/IVDR device whose first unit was placed on the EU market before 28 May 2026 and for which further units of the same model are still being placed after that date. The registration unit is the UDI-DI, not the batch or serial number. The practical regulatory question is therefore portfolio-based: which UDI-DIs have a placement history before 28 May 2026 and remain active in the EU market after that date? Manufacturers should also treat the 'same device' exemption as a documented equivalence assessment. A shared trade name alone may not be sufficient if the UDI-DI, model or catalogue number do not align. If a Regulation-device version has a new UDI-DI, the legacy version remains a separate registration item. Discontinued models still require attention because vigilance reporting can trigger a prior registration obligation.

Business impact

• Market access and supply continuity: Active EU models without the required UDI/Device registration may face customer, distributor or authority queries and may be treated as non-compliant with EUDAMED obligations. Late remediation can disrupt tenders, hospital supply and distributor onboarding.
• Vigilance readiness: If a serious incident or field safety corrective action arises for a discontinued model, the manufacturer must first register the device before it can submit the report in the Vigilance module. Companies should not remove master data for discontinued devices.
• Data consistency: Once the UDI/Device module is mandatory, an existing EUDAMED entry can become the Regulation-required registration where the same device is also registered nationally. This reduces duplicate entry in multiple Member States but raises the cost of inconsistent UDI-DI, model and trade-name data.
• Actor registration: Manufacturers, importers, EU authorised representatives, and system and procedure pack assemblers need valid Actor registrations before device records can be linked. Actor data errors can block device registration.
• Product-specific deadlines: Contact lenses with a primary UDI-DI share the 28 November 2026 deadline. Spectacle lenses, frames and ready-to-wear reading glasses have until 1 November 2028, but portfolio data should still be verified early.

Recommended actions before 28 November 2026

• Map all UDI-DIs placed on the EU market before 28 May 2026 and confirm which models still have units being placed on or after that date.
• Confirm Actor registrations for the manufacturer, EU authorised representative, importers, and system or procedure pack assemblers.
• Document the 'same device' exemption analysis for each legacy device against UDI-DI, model, catalogue number and trade name.
• Retain device master data for discontinued models and establish a trigger to register before any vigilance report or field safety corrective action.
• Reconcile national registrations with EUDAMED entries to avoid conflicting UDI-DI, model and trade-name data.
• Schedule submissions outside the EUDAMED maintenance windows on 3 November 2026 and allow time for data validation and correction before the deadline.