2023 EUDAMED white paper
1.79 MB
Overview of EUDAMED Requirements
What is EUDAMED? The European Database on Medical Devices (EUDAMED) is an online electronic system that has been put in place by the European Commission (EC) to facilitate the regulation of medical devices and in vitro diagnostics (IVDs) throughout the European Union (EU) single market.
The implementation of EUDAMED in the context of the MDR has been delayed, with the new go-live date expected in Q2 2024. Mandatory use of the database will begin in Q4 2024 for actors registration, clinical investigations, performance studies, vigilance and post-market surveillance. Mandatory use will begin in Q2 2026 for unique device identifier (UDI)/device registration.
To meet the mandatory use deadline, medical device stakeholders should prepare for compliance in terms of sufficient staff capacity, budgets and standard operating procedures ahead of the EUDAMED go-live date.
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