News about GMP/cGMP

31.10.2019

Introduction of EUDAMED postponed to 2022

On its website, the European Commission has officially announced that the launch of the European Database on Medical Devices, EUDAMED, has been postponed:

The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.

EUDAMED was originally scheduled to go live on 26 March 2020. The two-year delay will, after all, be a time extension for manufacturers to enter their product data in EUDAMED. This delay does not affect the entry into force of the MDR.


Source:

European Commission: Medical Devices, EUDAMED



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