EUDAMED registration in 2026: who needs to do what?

EUDAMED registration has had two mandatory tracks since 28 May 2026. Manufacturers, authorised representatives, importers and system or procedure pack producers register as actors. Manufacturers also register their devices in the UDI/Devices module. For devices that were already on the market before 28 May 2026 and are still supplied afterwards, a transition period runs until the end of November 2026.

On 27 November 2025 the European Commission published the notice that four modules of the database were ready for use. Six months later, use became mandatory. You will find an overview on the Commission’s page on the introduction of EUDAMED (opens in a new tab). The FAMHP summarised the consequences for Belgium in a news item on the Belgian registration obligations (opens in a new tab). Below, we turn those rules into concrete actions by role.

Which role does your company have?

Your role decides what you must do in EUDAMED. One company can combine several roles, for example manufacturer for its own product line and importer for another. Review the roles product group by product group.

• Manufacturer. You register your organisation as an actor and receive a Single Registration Number (SRN). Before you place a device on the market, you assign a Basic UDI-DI and register the device in the UDI/Devices module (Article 29 MDR).
• Authorised representative. If you represent a manufacturer outside the EU, you register yourself as an actor.
• Importer. You register as an actor. You also check that the device is registered and add your own details to that registration (Article 13(4) MDR). According to the FAMHP, a separate importer registration on the FAMHP web portal is no longer needed.
• Distributor. Distributors do not register in EUDAMED. In Belgium, the national duty to register on the FAMHP web portal (opens in a new tab) remains. Anyone who relabels or repackages devices has additional notification duties.
• System or procedure pack producer. You register as an actor before you place the system or pack on the market.

Which modules are relevant?

Four modules are mandatory: actors, UDI/devices, notified bodies and certificates, and market surveillance. Each has its own users.

• The actor module applies to every economic operator that has to register.
• The UDI/devices module is the manufacturer’s workspace. Importers add their own details there.
• In the notified bodies and certificates module, the notified body registers the certificates. For certificates issued before 28 May 2026, the Commission gives 28 May 2027 as the deadline.
• The market surveillance module is meant for the competent authorities and the Commission. Economic operators register nothing there themselves.

The vigilance and clinical investigation modules follow later. Until then, the national reporting procedures continue to apply.

For which devices is action needed, and when?

The deciding question is whether you still place a device on the market from 28 May 2026. You do not have to back-register an entire historical range. The Commission’s overview of UDI and device registration (opens in a new tab) gives the background.

• New devices. If you place the first unit on the market on or after 28 May 2026, you register the device beforehand.
• MDR devices that were already on the market. If you still supply units after 28 May 2026, you register them within the transition period.
• Legacy devices. Devices that stay on the market under the transitional provisions of Article 120 MDR are registered within the same period. This is not needed if the MDR version of the same device is already registered.
• Devices you no longer place on the market. If no new units are added after 28 May 2026, registration is in principle not needed. A vigilance or market surveillance action can still require it later.
• Old devices and custom-made devices. Devices placed on the market only before 26 May 2021 under the directives cannot be registered in the UDI/Devices module. Custom-made devices are excluded from that module.

Which end date applies? The sources word this differently. The MDR, as amended by Regulation (EU) 2024/1860, refers to no later than twelve months after publication of the notice of 27 November 2025. The FAMHP mentions an additional period from 28 May 2026 to 27 November 2026. The Commission shows 28 November 2026 in its timeline of transition periods for devices (opens in a new tab). We recommend finishing the registration by 27 November 2026 at the latest. That is a cautious working rule, not a new legal deadline.

What data should you prepare?

For actor registration, Annex VI of the MDR asks for, among other things, the type of economic operator, your name, address and contact details, and those of the person who registers on your behalf. The name and contact details of your PRRC are part of it too.

For each device, collect the Basic UDI-DI and the UDI-DIs, the risk class and the nomenclature code. You also need the notified body’s certificate details, the packaging configurations, how production is controlled (lot, serial number or expiry date) and the trade name or reference.

One approach that works well in practice: start from your active item list and link each item to a Basic UDI-DI, a certificate and a status (MDR or legacy). Sales data shows which items you still supplied after 28 May 2026. That quickly shows which registrations are still open.

For class I devices and IVDs, the notification to the FAMHP has no longer applied since 28 May 2026. The EUDAMED registration takes over that obligation.

Practical registration checklist

The table combines legal obligations with working rules we recommend. The “Type” column marks the difference. The owner is a suggestion; adapt it to your organisation.

When does outside support make sense?

Outside help pays off mainly when roles overlap, when the link between legacy and MDR versions is unclear, or when the supply status of a large range is hard to reconstruct. In those cases a short upfront analysis shows which registrations are really needed.

Your PRRC details are part of actor registration. Appointing a PRRC does not, however, fulfil the registration duty itself. We offer an external PRRC for medical devices under the MDR, alongside broader regulatory support.

We are glad to look with you at which role you hold and which steps are still open. Discuss your situation with us.

Frequently asked questions

Does a distributor have to register?

Not in EUDAMED. In Belgium, a distributor of medical devices must still register on the FAMHP web portal, under the Royal Decree of 15 November 2017.

What is the difference between actor and device registration?

Actor registration records who you are and gives you your SRN. Device registration describes what you place on the market, with the Basic UDI-DI, the UDI-DIs and the certificate details. A manufacturer needs both.

Which legacy devices are covered?

Legacy devices that you still place on the market from 28 May 2026, unless the MDR version of the same device is already registered. Legacy devices that you no longer supply are registered only if a vigilance or market surveillance action requires it.

Does registration replace CE marking?

No. CE marking remains based on the conformity assessment. EUDAMED registration is an additional obligation and does not make a device compliant.