EU triggers mandatory Eudamed use for diagnostics and medtech from May 2026

The European Commission has formally declared four of the six modules of the EU database on medical devices (Eudamed) functional, setting in motion a six-month transition period that will culminate in mandatory use of key database systems for medical device and diagnostics businesses operating in the EU market. 

The Commission's decision (EU) 2025/2371, published in the Official Journal of the European Union (OJEU) on 27 November 2025 (the notice), marks a milestone in the long-awaited implementation of the database.​

Gradual approach

Eudamed was established under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).​

The original regulatory framework envisaged that the database would become mandatory only once all six modules were fully operational. 

However, prolonged delays in development prompted a change in approach. Regulation (EU) 2024/1860, which entered into force in July 2024, amended the MDR and IVDR to enable a gradual rollout of the platform's various electronic systems. This amendment allowed individual modules to become mandatory once they have been independently audited and declared functional, rather than requiring completion of the entire system.

The Commission's notice represents the first formal application of this new module-by-module roll-out.​ Before its adoption, the Commission requested an independent audit of the completed electronic systems, the results of which were delivered in June. Based on this audit report, the Commission was able to verify that the relevant modules can operate appropriately and meet the functional specifications previously drawn up pursuant to the MDR.​

Four functional modules

The recent EU decision confirms functionality for four of the six Eudamed modules identified in article 1, namely: 

• The "Actor" module, which incorporates the electronic system on registration of economic operators.
• The "UDI/Device" module, which spans the unique device identifier (UDI) database and the electronic system for registration of medical devices (including diagnostics).
• The "NB/Certificates" module, which offers an electronic system for notified bodies and certificates.
• The "Market Surveillance" module, which is designed as an electronic system on market surveillance including by competent authorities.

Several of these modules have been available for voluntary use for some time. The "Actor" module has been accessible since December 2020, while the "UDI/Device" module and the "NB/Certificates" module have been available since October 2021. 

However, the "Market Surveillance" module has not been available for voluntary use and will be released only when it becomes mandatory, with access restricted to competent authorities and notified bodies.​

Two modules remain under development and are not addressed by the notice: the "Post-Market Surveillance and Vigilance" (VGL) module and the "Clinical Investigations/Performance Studies" (CI/PS) module. These will be released when they become mandatory, with no period of voluntary use preceding their activation. This suggests that economic operators will have to continue using national processes for vigilance reporting and clinical investigation submissions until those modules are declared functional at EU level.​

Compliance dates and transition

The publication of decision (EU) 2025/2371 triggers a six-month transition period. This means that the four declared modules will become mandatory on 28 May 2026.​ From that date, relevant Eudamed-related obligations under the MDR and IVDR will apply in full to economic operators, notified bodies, and competent authorities.

The Commission's Q&A document on practical aspects related to the gradual roll-out of Eudamed provides guidance on the implications of this transition.

Until the mandatory use date of 28 May 2026, the corresponding provisions of the pre-MDR and pre-IVDR EU directives on medical devices continue to apply insofar as they relate to registration obligations. This arrangement is intended to provide a cut-off point and prevent double registration requirements for businesses during the transition.​

Devices placed on the market before May 2026

The timing of when a medical device, an in vitro diagnostic or a system and procedure pack (SPP) is first placed on the EU market has a bearing on the registration deadlines.

The Commission's guidance documentation and timeline infographics distinguish between two principal scenarios.​

Devices – whether legacy or MDR/IVDR-compliant – placed on the market before 28 May 2026, where additional units will continue to be marketed thereafter, must be registered on Eudamed (in the "UDI/Device" module) by 28 November 2026. That is twelve months after the OJEU publication date. A single registration covers all units with the same UDI-device identifier (UDI-DI), irrespective of their individual placement dates.

Devices with no remaining sales units from 28 May 2026 onwards do not require registration in the "UDI/Device" module, unless a post-market surveillance action or a vigilance action is initiated. Should such action arise after the VGL module becomes mandatory, the device must be registered to enable submission of all required reports. The device's manufacturer and authorised representative must also be registered in Eudamed's "Actor" module before submitting any such reports.

Notified bodies must register in the "NB/Certificates" module all certificates issued under the MDR or IVDR prior to the module's mandatory use date. The deadline for this retrospective registration is 28 May 2027. That is eighteen months after the notice's OJEU publication. Only the latest certificate version and the most recent notified body decision related to that version require registration.

Placing on the market after May 2026

From 28 May 2026 onwards, new MDR and IVDR devices (excluding custom-made, investigational, and performance study devices) and SPPs must be registered in the "UDI/Device" module before their first unit is placed on the EU market. This single registration covers all subsequent units placed on the market with the same UDI-DI.

This marks an important shift, as Eudamed registration will finally become a prerequisite for placing new products on the EU market from 28 May 2026. Manufacturers and authorised representatives must take two steps: firstly, register their organisations in the "Actor" module; secondly, prepare device data according to Eudamed functional specifications. Both steps should be completed before any market launch planned for May 2026 onwards.

Certificates issued under the MDR or IVDR after the "NB/Certificates" module becomes mandatory must be registered immediately upon issuance. Updates and decisions relating to pre-mandatory certificates must also be registered in the same module once issued, after mandatory use begins.

Osborne Clarke comment

The Commission's decision (EU) 2025/2371 marks a turning point after years of delays and uncertainty around Eudamed. With the publication of the notice on 27 November, medtech and diagnostics businesses finally have concrete dates to work with and can begin planning in earnest for the transition to mandatory use.

Businesses that have already taken advantage of the voluntary procedure have had the opportunity to test the system, iron out data issues, and build internal processes around the database's requirements. For medtech and diagnostics organisations coming to it fresh, the next six months are likely to require focused effort. The Commission's Eudamed information centre and "Playground" testing environment can provide valuable support for teams preparing for the transition.

The distinction between devices and SPP already on the market and new launches warrants close attention. If devices were placed on the market before 28 May 2026 and will continue to be sold thereafter, economic operators have until 28 November 2026 to register them – a welcome twelve-month window. Registering earlier could save headaches down the line, particularly if data quality issues crop up that need sorting with the notified body or internal teams. For any product launching after May 2026, Eudamed registration becomes part of any medtech business' critical path to market, and should preferably be built into project timelines.

Organisations operating from outside the EU may wish to ensure robust communication channels with their EU-based authorised representatives and importers. Coordination between parties will be essential, and any gaps in communication could directly affect a company's ability to place products on the EU market. Notified bodies, meanwhile, are facing their own tight deadlines for retrospective certificate uploads by May 2027 and may benefit from proactive engagement with manufacturers on data alignment.

It is also worth remembering that the notice currently covers only four of the six Eudamed modules. The VGL and CI/PS modules are still to come, and when they do arrive, they are likely to bring their own compliance obligations and operational changes. Participation in the Commission's ongoing workshops and training initiatives may prove valuable for teams seeking to stay abreast of evolving guidance and implementation timelines.