The Life Sciences and IP Litigation team at MFA Legal & Tech has prepared a document analysing the formal entry into the operational phase of the European Database on Medical Devices (“EUDAMED”), which takes effect today, 28 May 2026.
Under the new framework of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), the use of the first four modules of the system is now mandatory as of today: Actor registration, UDI/device registration, Notified bodies and certificates, and Market surveillance.
This transition requires manufacturers and other economic operators to be registered in the system, obtain a Single Registration Number (SRN), and ensure their devices are recorded in EUDAMED prior to being placed on the EU market. Although the modules for vigilance/post-market surveillance and clinical investigations are still under development, the system is already establishing itself as a central pillar of core compliance. This milestone progresses in parallel with the European Commission's legislative proposal to simplify the regulation for medical devices.
The team at MFA Legal & Tech is available to provide practical and strategic guidance on the implications of EUDAMED and the evolving EU medical devices framework.
