👉 28 May 2026 → EUDAMED becomes mandatory (partially)
On 27 November 2025, the European Commission announced the full functionality of four of the six EUDAMED modules through Decision (EU) 2025/2371, published in the Official Journal.
This starts a 6-month transition period, making the use of the first four modules mandatory as of 28 May 2026. Economic operators that have not yet used the modules on a voluntary basis should act as soon as possible.
👀 What exactly enters into force in 2026?
From that date, the first 4 main modules become mandatory:
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“Actor Registration” module ACT Its purpose is the mandatory registration of economic operators, i.e. manufacturers (including manufacturers of systems and procedure packs), authorised representatives and importers, in order to obtain the Single Registration Number (SRN). This registration is a necessary prerequisite for all subsequent operations in the EUDAMED modules, as provided for in Articles 31 of the MDR (EU) 2017/745 and 28 of the IVDR (EU) 2017/746.
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“UDI/Devices Registration” module UDI/DEV It manages the UDI identifiers (UDI-DI/UDI-PI) through a central database for MDR/IVDR devices. It collects detailed information on devices, including the risk class, the Basic UDI and data relating to packaging and sales units. For legacy (MDD/IVDD) and regulated devices, as well as for custom-made devices or those whose individual units are no longer placed on the market after the module becomes mandatory, registration will only take place in the event of serious incidents, field safety corrective actions (FSCA) or surveillance needs, using specific EUDAMED DI/ID identifiers instead of the standard UDI.
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“Notified Bodies and Certificates” module NB/CRF It allows Notified Bodies (NB) to register and manage the certificates issued for devices compliant with the MDR and IVDR. It also collects the Summaries of Safety and Clinical Performance (SSCP), transmitted directly by the Notified Bodies for the highest-risk devices.
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“Market Surveillance” module MSU It reserves access to the Competent Authorities for the management of market surveillance activities in the post-market phase, including inspections and the management of non-conformities.
A clear summary:
✔️ 27/11/2025 → official publication (the countdown begins)
✔️ 28/05/2026 → obligation to use the first modules
⏳ approx. 2027 → remaining modules
⚠️ Manufacturers must focus on the ACT and UDI/DEV modules, which are their direct responsibility:
✔️ Priority 1: obtain the Single Registration Number (SRN). Essential action: without the SRN it is impossible to proceed with the remaining registrations.
✔️ Priority 2: prepare the UDI data for the UDI/DEV module. Review and organise the details of the UDI codes to avoid blockages in the marketing of your devices.
👉 The mandatory use of the EUDAMED modules is not a finish line, but the starting point for centralised and transparent management of the device throughout its entire life cycle.
👉 There is no more time to lose. It is essential to complete registration in the ACTOR module and in the UDI/DEV module as soon as possible to avoid operational disruptions and non-compliance risks.
⚠️✔︎ For strategic regulatory consultancy, training and direct support in the use of the EUDAMED modules, the experts at MeDev are at your side. Contact: info@medev.es
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