EUDAMED in 2026: a practical guide for manufacturers and authorised representatives

EUDAMED, the European Database on Medical Devices, centralises information on medical devices and in vitro diagnostic devices placed on the EU market. Provided for by Article 33 of the MDR and Article 30 of the IVDR, announced for 2020 and rolled out module by module, it reached its decisive milestone in 2026: since 28 May 2026, four of its six modules are mandatory.

This guide sets out what is required today, and how to organise for it.

Why EUDAMED exists

Before EUDAMED, each Member State kept its own registers: registrations, certificates, incidents, recalls were all fragmented. EUDAMED pursues four goals:

1. Transparency: who makes what, under which certificates, with which incidents
2. Traceability, through the UDI (Unique Device Identification)
3. Coordination between Member State competent authorities
4. Simplification: one European registration instead of national registers

The six modules and their status

Module	Purpose	Status since 28 May 2026
Actors	Registration of manufacturers, authorised representatives, importers, system and procedure pack producers	Mandatory
UDI and devices	Device registration with Basic UDI-DI and UDI-DIs	Mandatory
Notified bodies and certificates	Certificates issued, suspended or withdrawn, SSCPs	Mandatory
Clinical investigations and performance studies	Study applications and notifications	Not mandatory yet
Vigilance and post-market surveillance	Serious incidents, FSCAs, trend reports, PSURs	Not mandatory yet
Market surveillance	Competent authority activities	Mandatory (authorities only)

This module-by-module roll-out was made possible by Regulation (EU) 2024/1860. The Commission published the notice confirming the full functionality of the first four modules at the end of November 2025, which set their mandatory use six months later. For devices already on the market at that date, the same regulation provides transitional registration periods.

Actor module: the first step

Registration and SRN

Before placing a device on the market, the manufacturer, the authorised representative and the importer register in the Actor module (MDR Article 31). The competent authority of the country of establishment verifies the information, then EUDAMED assigns an SRN (Single Registration Number), the operator's European identifier.

In practice:

1. Create an EU Login account
2. Submit the actor registration request, with the information listed in MDR Annex VI, Part A, including the contact details of the PRRC(s)
3. Validation by the competent authority
4. SRN assignment

Importers must also verify, within two weeks of placing a device on the market, that the manufacturer or authorised representative is registered (Article 31(3)).

Keeping data up to date

Two distinct obligations, often confused:

• Any change to the actor's information is entered in EUDAMED within one week (Article 31(4))
• The accuracy of the data is confirmed no later than one year after registration, then every second year (Article 31(5))

UDI and device module

Before placing a device on the market, custom-made devices excepted, the manufacturer assigns it a Basic UDI-DI and provides the required data to the EUDAMED UDI database (MDR Article 29). For a device requiring a notified body, this assignment takes place before the conformity assessment application, and the notified body references the Basic UDI-DI in the certificate.

The data include the UDI-DI of each model and packaging level, the risk class, the code of the European nomenclature EMDN, certificate references and characteristics such as sterility or the presence of regulated substances.

Common mistakes:

• A poorly chosen EMDN code, which distorts how the device is found and may trigger a correction request
• An incorrect link to the notified body certificate
• A new UDI-DI forgotten after a change that requires one (trade name, model, sterile packaging, quantity per package, critical warnings)

Notified bodies and certificates module

For a manufacturer, this module is mainly used to check two things: the exact scope of a notified body's designation, and the status of its own certificates.

QARA tip: before choosing a notified body, check that its designation really covers your type of device. Scope codes are precise, and an implantable class IIb device is not covered by a designation limited to non-implantable devices.

MDCG 2026-4 specifies how SSCPs (summaries of safety and clinical performance) are handled in EUDAMED since mandatory use: the notified body uploads them when registering the certificate, and the manufacturer then takes over the validated versions.

Clinical investigation and vigilance modules

These two modules are not mandatory yet. National procedures therefore remain the rule:

• Clinical investigations are notified to, or authorised by, the national authorities concerned
• Serious incidents are reported to the national competent authority within the MDR Article 87 deadlines: 2 days for a serious public health threat, 10 days for a death or unanticipated serious deterioration in health, 15 days for other serious incidents

Mistakes to avoid

1. Leaving the SRN to the last minute: without an SRN, no notified body application and no device registration
2. Confusing update and confirmation: one week to report a change, one year and then every two years to confirm the whole record
3. Confusing the Basic UDI-DI and the UDI-DI: the former groups a family of devices, the latter identifies a model and a packaging level
4. Choosing the EMDN lightly: the code determines how the device is found, compared and monitored
5. Letting EUDAMED and documentation drift apart: a change in EUDAMED goes with an update of the technical documentation and the EU declaration of conformity

Operational good practice

• Centralise UDI data in a master system (PIM, ERP) that feeds EUDAMED, rather than re-keying it
• Appoint an EUDAMED lead for day-to-day entries, under the PRRC's supervision
• Check registrations at regular intervals against actual production
• Follow MDCG documents and Commission communications, which regularly refine fields and procedures

Official resources

• EUDAMED portal: ec.europa.eu/tools/eudamed
• MDCG documents on EUDAMED, including MDCG 2021-1 (harmonised administrative practices), MDCG 2026-4 (SSCP) and MDCG 2026-5 (UDI assignment)
• European Commission user guides
• National competent authority EUDAMED pages

Conclusion

With the 28 May 2026 obligation, EUDAMED has moved from awaited tool to everyday obligation. QARA teams should treat it as an operational reference: accurate data, updated within the week and confirmed on schedule.

MedQara continuously monitors MDCG documents, Commission communications and the roll-out of the last EUDAMED modules, so you are alerted as soon as a change affects your portfolio.

Read also: UDI and EUDAMED: manufacturer obligations · PRRC: who can be one and what responsibilities · Understanding the MDR