EUDAMED Mandatory Modules: Actor Registration, UDI Device Registration and Deadlines

For years EUDAMED, the European database on medical devices, was a project that manufacturers could mostly ignore. That period is over. Since 28 May 2026 four of its modules have been mandatory, and a second deadline for devices that were already on the market arrives on 28 November 2026. This guide explains what EUDAMED is, which modules are live, who has to register what and by when, and how to run the work as a project rather than a last-week scramble.

What EUDAMED is for

EUDAMED is the information system the MDR and IVDR require the Commission to build. It brings together data that used to sit in national systems, so that authorities, notified bodies, economic operators and the public can see the same information about devices on the EU market. It has six modules:

Module	Purpose	Status for mandatory use
Actor registration	Registers manufacturers, authorised representatives, importers, system and procedure pack producers; issues the Single Registration Number (SRN)	Mandatory since 28 May 2026
UDI / device registration	Registers each device through its UDI-DI and basic UDI-DI	Mandatory since 28 May 2026 (legacy devices by 28 November 2026)
Notified bodies and certificates	Notified bodies enter certificates and related information	Mandatory since 28 May 2026 (older certificates by 28 May 2027)
Market surveillance	Used by competent authorities for their market surveillance activities	Mandatory since 28 May 2026 (for authorities)
Vigilance and post-market surveillance	Serious incident, FSCA, trend and PSUR reporting	Under development; mandatory six months after its notice
Clinical investigations and performance studies	Applications and reporting for studies	Under development; mandatory six months after its notice

The gradual roll-out comes from Regulation (EU) 2024/1860, which amended the MDR and IVDR so that each module becomes mandatory six months after the Commission publishes a notice confirming that it is functional. Check the Commission’s EUDAMED pages for the latest status of the two remaining modules, because forecast dates have moved before.

Who has to do what

Role	EUDAMED duty
Manufacturer	Register as an actor and get an SRN. Register devices (basic UDI-DI and UDI-DI data) in the UDI/device module. Provide data for certificates with the notified body.
Non-EU manufacturer	Same duties, and every device registration must name the EU authorised representative with an active mandate in EUDAMED.
Authorised representative	Register as an actor and accept the mandate in the system. See EU MDR economic operators.
Importer	Register as an actor, and verify that the manufacturer or authorised representative is registered. Device registration stays with the manufacturer.
Distributor	No EUDAMED registration, though national rules may still apply.
Notified body	Enter certificates, assessment decisions and related information.

Actor registration and the SRN

The actor module comes first because everything else depends on it. The manufacturer submits its details, including the person responsible for regulatory compliance (PRRC), and the competent authority verifies the data and issues the SRN. You need the SRN to apply to a notified body and to register devices.

• Settle the PRRC appointment and details before you start, because the registration asks for them.
• Keep the record up to date. Changes must be reflected promptly, and the data must be confirmed periodically.
• For several legal entities, decide which entity is the manufacturer of record for each device before registering.

UDI and device registration

Devices are registered at UDI-DI level, so one entry covers all units that share a UDI-DI. The registration contains data such as device name and trade name, risk class, intended purpose attributes, packaging configurations, sterile and single-use status, labelling attributes, the certificate link where a notified body is involved, and the authorised representative.

• New devices: must be registered before the first unit is placed on the EU market. There is no grace period.
• Legacy devices still supplied: devices placed on the market before 28 May 2026 and still being supplied must be registered by 28 November 2026. Devices that are no longer supplied do not need registration unless later vigilance reporting makes it necessary.
• Directive-era devices (MDD, AIMDD, IVDD) that benefit from the transition periods are handled under the Commission’s guidance for legacy devices. Check how your device is treated and which identifiers you can use.
• Shared UDI-DI: where a regulation device and a legacy device share the same identifier and characteristics, a separate entry for the legacy version may not be needed.

This is much easier if your UDI master data is clean. Our guide to UDI in the EU and US explains how basic UDI-DI, UDI-DI and UDI-PI fit together and how to avoid duplicate or inconsistent data.

Notified body certificates

Notified bodies enter certificates into EUDAMED for new certificates after mandatory use, and for older certificates by 28 May 2027. Agree with your notified body how the certificate and the device registration will be linked, because UDI and device data for some devices become public only once the certificate is entered. See EU medical device regulations (MDR and IVDR) for how certificates fit the wider system.

Building a EUDAMED project plan

1. Inventory. List every device and variant on the EU market, with its UDI-DI, basic UDI-DI, class, legal status (MDR, MDD certificate, IVDR, IVDD) and whether it is still supplied.
2. Clean the master data. Fix naming, packaging, sterility, labelling and certificate fields in your own PLM or ERP system before you load them.
3. Register actors. Get the manufacturer, authorised representative and importer records live and linked.
4. Decide the upload route. Choose between manual entry, bulk upload (XML or system-to-system exchange) and a third-party tool, based on the number of devices.
5. Pilot a small family. Register one device family and review the entries, including how they appear to the public.
6. Run the bulk load for the remaining devices, and reconcile the result against your inventory.
7. Add EUDAMED to change control. A change in a registered attribute, a new variant or a certificate change must trigger an update. Build it into change control.
8. Prepare for the vigilance module. Your post-market surveillance and complaint processes should be ready to report through EUDAMED when that module becomes mandatory.

Common mistakes

• Waiting until November to start, then discovering that actor data, PRRC details or authorised representative mandates were incomplete.
• Registering devices before the UDI data is stable, then having to correct many entries.
• Forgetting that non-EU manufacturers need an authorised representative mandate visible in EUDAMED.
• Assuming that distributors must register.
• Not agreeing the certificate link with the notified body.
• Treating EUDAMED as a one-time upload, with no process to keep the data current.

Frequently asked questions

Is EUDAMED mandatory now?

Four modules are mandatory since 28 May 2026: actor registration, UDI/device registration, notified bodies and certificates, and market surveillance. The vigilance and post-market surveillance module and the clinical investigation and performance study module are not yet mandatory.

Do I have to register devices that are already on the market?

If a device was first placed on the market before 28 May 2026 and you are still supplying it, you need to register it in the UDI/device module by 28 November 2026. Devices that you no longer supply generally do not need registration unless a later report requires it.

Does a non-EU manufacturer need an authorised representative in EUDAMED?

Yes. Device registrations must identify the EU authorised representative, and the mandate must be active in the system.

What is an SRN?

The Single Registration Number is the identifier issued to an economic operator after the competent authority verifies its actor registration. You need it for notified body applications and device registration.

When will the vigilance module be mandatory?

Six months after the Commission publishes a notice that the module is functional. Forecasts have changed before, so follow the Commission’s EUDAMED roadmap and plan to report serious incidents and FSCAs in the system once the notice appears.

Dates and technical details for EUDAMED are set by Regulation (EU) 2024/1860, Commission Decision (EU) 2025/2371 and the Commission’s guidance, and they can change. The Commission’s own Q&A documents are practical guidance, not binding law. Confirm the current position with the Commission, your notified body and your regulatory advisers.

Related reading

• UDI in the EU and US: the data structure behind device registration.
• EU medical device regulations (MDR and IVDR): the full map of roles, classes and deadlines.
• EU MDR economic operators: who needs to register and why.
• IVDR guide: EUDAMED duties for in vitro diagnostic manufacturers.
• EU MDR technical documentation: keep your file consistent with what you register.

Talk to the AptSkill team

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