EU parliament postpones Medical Devices Regulation (MDR) for one year.

EU parliament postpones the application of the Medical Devices Regulation (MDR) for one year.

This postponement will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis.

Currently, the EC database on medical devices, Eudamed2, is a secure web-based portal. It is a central repository for information on market surveillance exchanged between national competent authorities and the Commission. Its use is restricted to national competent authorities, it is not open for consultation and is not publicly accessible.

However, the new medical devices regulations contain important improvements including a much larger EUDAMED database. The new EUDAMED will be multipurpose. It will function as a registration system, a collaborative system, a notification system, a dissemination system (open to the public), and will be interoperable.

Author(s)Source
European UnionEuropean database on medical devices (EUDAMED) 20.04.2020
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