The Commission of the European Union (EU) have issued requirements for the medical devices database intended to serve as a repository for detailed information on medical devices approved under the EU’s Medical Devices Regulations (EU 2017/745 MDR).
This has been published in the official journal (OJ) of the European Union, the Commission’s Implementing Regulation provides a framework for the operation and use of the European Database on Medical Devices (Eudamed), as required under the MDR. The Regulation addresses issues related to modes of database access, measures to ensure the security of the database and the information it contains, and strategies to deal with database malfunctioning.
Eudamed was originally slated to go live at the time of the MDR’s data of application in 2020. The Commission now expects that the complete Eudamed system will launch by not later than May 2022.