What’s new
Since 28 May 2026, four parts of EUDAMED, the European database on medical devices, are no longer optional. Commission Decision (EU) 2025/2371, published in the Official Journal on 27 November 2025, confirmed that the systems for actor registration, UDI and device registration, notified bodies and certificates, and market surveillance work as intended. Under the rules Regulation (EU) 2024/1860 added to Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), that publication started the clocks.
The next one runs out on 27 November 2026. By then, manufacturers must have registered in EUDAMED every device whose first unit reached the EU market before 28 May 2026 and that is still being placed on the market. This covers devices certified under the MDR or IVDR and legacy devices still sold under the transitional provisions. A device whose last unit was placed on the market before 28 May 2026 does not need registering on that ground alone.
Two modules are still outside the obligation: vigilance and post-market surveillance, and clinical investigations and performance studies. Serious incidents, field safety corrective actions and clinical investigation applications keep following national routes until each of those modules is declared functional.
What EUDAMED is
EUDAMED is the European database on medical devices that the MDR and IVDR set up, run by the European Commission. It is organised in six modules: actor registration, UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance. Much of what goes in is public, so competent authorities, notified bodies, distributors, hospitals and patients all read the same record. A module becomes mandatory only after the Commission confirms that it works; until then, national systems carry the obligation.
What now: who does what
Manufacturers carry the device registration. First comes the actor registration: the company submits its details through an EU Login account, the competent authority of its Member State checks them, and the company receives its Single Registration Number (SRN). Nothing else in EUDAMED can be done without it. Then each device goes into the UDI and device module with its Basic UDI-DI, its UDI-DIs, its risk class and, where a notified body is involved, the certificate reference. No other operator can register a device for the manufacturer.
Authorised representatives register themselves and link to the non-EU manufacturers they represent. They do not register devices. They must check that the manufacturer and its devices are registered before acting for them, and an authorised representative that does not do this check is the weak link a competent authority will look at first.
Importers register, link to the manufacturers they import from, and verify the registration before placing a device on the market. Their labelling duty (name and address on the device, packaging or accompanying document) is separate and still applies.
Distributors do not register in EUDAMED. The MDR leaves Member States free to keep national registration of distributors, so national rules still decide what a distributor has to notify.
Notified bodies have entered every certificate issued since 28 May 2026 at issue. Certificates issued before that date must be in EUDAMED by 27 May 2027; only the latest version and the most recent related decision are needed.
One practical point we see often: a small manufacturer, or a non-EU manufacturer whose access runs through one person, names a single EUDAMED administrator. If that person leaves, the company can lose access to its own records at the worst moment. Name at least two administrators and keep both active.
Portugal: SIDM after 28 May 2026
INFARMED announced the change in a circular dated 20 May 2026 and took SIDM (Sistema de Informação para Dispositivos Médicos) offline from 26 to 28 May 2026 to connect it to EUDAMED. Since then, device data registered in EUDAMED is meant to flow into the national record rather than be keyed in twice.
Distributors established in Portugal should check with INFARMED which national notifications still apply to them.
What it means for your product
If you have devices on the EU market today, list them now: which are already in EUDAMED, which first reached the market before 28 May 2026 and are still being sold, and which have stopped. The second group is the one with a deadline in less than three weeks. Check that the data you enter matches the technical documentation and the label, because the record is public and authorities in every Member State read the same entry.
If you are a non-EU manufacturer, ask your authorised representative how and when it verified your registration. If you appoint us as your European Authorised Representative or outsourced Person Responsible for Regulatory Compliance (PRRC), EUDAMED registration management is part of the work.
Registration and the rules for distribution in Portugal are one step on our medical devices route: Registration and distribution.
Related briefing: What does an EU Authorised Representative do, and how is a PRRC different?