As many of our clients are already aware, registration in the European Database on Medical Devices (EUDAMED) became mandatory on 28 May 2026. From this date, all economic operators wishing to place medical devices or in vitro diagnostic medical devices on the European Union market must comply with EUDAMED registration requirements in accordance with the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
EUDAMED is a central component of the EU medical device regulatory framework and has been developed to improve transparency, traceability, and patient safety throughout the European market. The database consolidates key regulatory information into a single digital platform, providing greater visibility of medical devices and the organisations responsible for them. The system facilitates the exchange of information relating to economic operators, medical devices, certificates, clinical investigations and performance studies, vigilance activities, and market surveillance. By centralising this information, EUDAMED supports more effective regulatory oversight throughout the entire lifecycle of a medical device and enhances cooperation between manufacturers, authorised representatives, notified bodies, competent authorities, and the European Commission.
To maintain compliance and continued access to the EU market, all relevant economic operators must ensure that their registration details and device information are accurate, complete, and kept up to date within EUDAMED.
The following EUDAMED modules became mandatory from 28 May 2026:
- Actor Registration
- UDI/Device Registration
- Notified Bodies and Certificates
- Market Surveillance
More information can be accessed using the following link
