EU: Implementing Regulation for Eudamed Medical Device Database
In November 2021, the European Commission adopted the implementing regulation (EU) 2021/2078 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed).
The regulation, which enters into force on 19th December 2021, provides a framework for the operation of the system, and its publication follows the release of the Eudamed modules on UDI/device registration and Notified Bodies and Certificates in October 2021.
The implementing regulation sets out definitions such as ‘actor’, ‘authorized user’ and ‘local user administrator’ and describes modes of access to the system. In the section describing modes of access, the Commission states that “Eudamed shall be accessible through machine-to-machine data exchange services to actors other than the competent authorities and notified bodies.” The document also describes registration in Eudamed and access to the system via the restricted website.
The regulation states that the Commission will own Eudamed and will exercise all administration rights. In regards to the processing of personal data, the document states that “personal data shall be processed in Eudamed for the purpose of complying with the obligations set out in Regulations (EU) 2017/745 and (EU) No 2017/746.” Information such as the names and contact details of actors and authorized users will be processed in Eudamed.
Currently, the final Eudamed modules on Clinical Investigations and Performance Studies, Vigilance and Post-Market Surveillance, and Market Surveillance have yet to be implemented and the Commission has stated that the remaining modules will be released when EUDAMED is fully functional.
Want to achieve uninterrupted global market access for your medical devices? Find out more.
Market Insights straight to your inbox
Join 30,000+ product compliance & market access experts around the world