EUDAMED’s First Four Modules Are Now Mandatory
- 4 hours ago
- 2 min read
What Regulatory Teams Need to Know
As of 28 May 2026, the first four modules of EUDAMED are mandatory to use, marking an important step in the European Union’s move toward a more digital and transparent medical device regulatory system. This change follows the European Commission’s Decision (EU) 2025/2371, which confirmed that the modules met their functional specifications and triggered a six-month transition period.
EUDAMED, the European Database on Medical Devices, is designed to support the
implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746
(IVDR). The database is structured around six interconnected modules, and the first
four are now the ones that must be used.
The Four Mandatory Modules
The modules now mandatory from 28 May 2026 are:
Actor registration.
UDI/device registration.
Notified Bodies and Certificates.
Market Surveillance.
Actor registration covers economic operators such as manufacturers, authorized
representatives, and importers, while UDI/device registration supports the traceability of devices across the supply chain. The Notified Bodies and Certificates module centralizes information on certificates and related decisions, and the Market
Surveillance module supports competent authorities in monitoring compliance.
Why This Matters
This rollout matters because EUDAMED is becoming the required channel for
obligations tied to these four modules, rather than a voluntary tool. For regulatory affairs teams, this means more structured data management, stronger traceability, and greater visibility for authorities across the device lifecycle. It also means companies need to ensure their internal records, submission processes, and role-based responsibilities are ready for the system’s mandatory use.
What Companies Should Do
Organizations should confirm that their EUDAMED registrations are complete and that device data is accurate, consistent, and ready for submission. They should also
coordinate with authorized representatives, importers, and notified bodies so that all stakeholders understand their responsibilities under the new workflow. Early preparation is especially important for companies placing new MDR- or IVDR-compliant devices on the market, since timing obligations can differ depending on the device and registration category.
Looking Ahead
The mandatory rollout of the first four modules is not the end of EUDAMED’s
development. Other modules, including vigilance and clinical investigation-related
functions, remain part of the broader EUDAMED framework and will continue to come online as the system evolves. For regulatory professionals, this is a useful moment to build fluency in EUDAMED because it is quickly becoming a core part of EU medical device compliance.
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