The European Commission has officially confirmed the functionality of four EUDAMED modules – Actor, UDI/Device, Notified Bodies & Certificates, and Market Surveillance. This marks a significant step forward in the ongoing rollout of the MDR/IVDR regulatory framework.
KEY REGULATORY MILESTONES :
27 Nov 2025 – Functionality confirmation published in the OJEU
28 May 2026 – Mandatory use of the 4 modules begins
28 Nov 2026 – Transition period ends for device registration
28 May 2027 – Transition period ends for Notified Bodies to register certificates
From the 28 May 2026, organisations will have to switch from national to central EUDAMED registration processes of actors, devices, certificates and any new devices and system/procedure packs to be placed on the market must be registered in EUDAMED. There is a transition period until 27 November 2026 for devices already in the market.
This development provides long-awaited legal clarity to industry and authorities, paving the way for full EUDAMED use and enhanced transparency within the EU medical device landscape.
Learn more: https://lnkd.in/ecnfAGcx