Four EUDAMED Modules are now mandatory

28 May 2026 marks a major milestone for the European medical devices’ regulatory framework, as four modules of EUDAMED are now mandatory to use, these being:

– Actors
– UDI/Devices
– Notified Bodies & Certificates
– Market Surveillance

The long overdue use of EUDAMED is intended to enhance transparency, traceability, and regulatory cooperation across the medical devices sector in the EU, progressing towards “having a living picture of the lifecycle of medical devices available in the EU,” to quote the Commission website.

EUDAMED will be used by manufacturers, authorised representatives, importers, notified bodies, and competent authorities to ensure regulatory compliance, as it serves as the backbone of the Medical Devices Regulations. Citizens, patients, healthcare professionals, and all key actors in the sector will now have access to information on devices placed on the EU market.