EUDAMED reaches a major milestone: mandatory use of the first four modules begins
Posted on 04.06.2026
28 May 2026 marks a major step forward in the EU’s regulatory framework for medical devices and in vitro diagnostic medical devices. From this date, the first four modules of EUDAMED, the European Database on Medical Devices, become mandatory for use, moving from voluntary to a legally required part of the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
EUDAMED is designed to strengthen transparency, traceability and coordination across the EU medical devices regulatory system. It is the central platform through which key regulatory information is submitted, maintained and accessed.
From 28 May 2026, use of the following modules becomes mandatory: Actor Registration, UDI/Devices Registration, Notified Bodies & Certificates, and Market Surveillance.
- For economic operators, EUDAMED becomes an operational compliance requirement, requiring actor registration to obtain a Single Registration Number and UDI/device registration to support product identification and traceability. The Notified Bodies & Certificates module supports the digital availability of certificate information.
- The Market Surveillance module enables competent authorities to coordinate oversight activities.
- For healthcare systems and the wider public, EUDAMED provides visibility of medical devices and IVDs placed on the EU market.
EUDAMED compliance depends not only on entering data, but on maintaining accurate, consistent and up-to-date information across internal systems, certificates, product portfolios and UDI records. High-quality, structured and consistent data in EUDAMED will support a more predictable regulatory environment. EUDAMED will increasingly act as a common reference point for regulators, notified bodies and economic operators.
Additional details can be found on the official website of the European Commission on EUDAMED.
For more information, contact Katalin Máté, Senior Expert, Regulatory Affairs (IVDR & MDR).