EUDAMED is the IT system established by EU MDR/IVDR for registering devices, economic operators, certificates, clinical investigations, vigilance, and market surveillance information. EUDAMED is built from six modules: actor registration, UDI and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance. Regulation (EU) 2024/1860 allows modules to become mandatory one by one once each is declared functional, instead of waiting for the full system. Until a module is mandatory, national systems and paper processes continue to apply.

Why it matters

EUDAMED is being rolled out by module. Mandatory use of certain modules begins as each is declared functional.

Common pitfalls

•A common misconception is that EUDAMED is a single, fully functional system, when in reality it is being deployed in a modular fashion, with different functionalities becoming mandatory at different times.
•Companies often underestimate the data entry burden and the need for accurate, consistent data across all modules, leading to delays in compliance.
•Some stakeholders mistakenly believe that EUDAMED replaces national registration requirements entirely, which is not always the case, necessitating careful review of Member State specific guidance.
•Failing to establish a robust internal process for EUDAMED data submission and maintenance can result in non-compliance and potential market access issues in the EU.
•Assuming that EUDAMED functionality will be static can lead to issues, as the system is subject to ongoing updates and changes, requiring continuous monitoring by economic operators.

Sources

EUDAMED · European Commission
RAPS Regulatory Focus · RAPS
FDA - Medical Devices · FDA

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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Post-market actions - Recall vs field action, Removal vs correction.

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