EU Commission Sets Out Regulations for Medical Devices Database

The Commission of the European Union (EU) has issued its requirements for the medical device database intended to serve as a repository for detailed information on medical devices approved under the EU’s Medical Device Regulation ((EU) 2017/745, also known as the MDR).

Published in the Official Journal 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.

Read the Commission’s Implementing Regulation regarding the Eudamed medical device database as published in the Official Journal.

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