EUDAMED · November 15, 2025

EUDAMED Core Modules Become Mandatory

EUDAMED core modules (economic actor, UDI/device, certificate, market surveillance) become mandatory 6 months after Official Journal publication; national registrations replaced.

High impact Medical Devices EU-wide medical-deviceseudamednotified-bodiespost-market-surveillance

First phase of EUDAMED database becomes mandatory 6 months after Official Journal publication. All manufacturers must register as economic actors and register devices in UDI/Device module. National registrations will be replaced. Notified Bodies must register certificates. Market surveillance module also becomes mandatory.

Dates and deadlines

Implementation Date

May 15, 2026

Read the official source ↗

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