EUDAMED

EUDAMED Vigilance Module Mandatory

Manufacturers must report all adverse events and post-market surveillance data through EUDAMED Vigilance module, replacing national systems.

High impact Medical Devices EU-wide medical-deviceseudamedpost-market-surveillance

Manufacturers must report all adverse events, field safety corrective actions, and post-market surveillance data through EUDAMED Vigilance module. Replaces national vigilance reporting systems. Legacy devices still in distribution must be registered if vigilance event occurs.

Dates and deadlines

Implementation Date

July 15, 2027

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Published by EUDAMED. HealthSignal links to the original document; the summary above is extracted from the source text.