EUDAMED Expected to be Fully FunctionalEUDAMED Expected to be Fully FunctionalEUDAMED Expected to be Fully FunctionalEUDAMED Expected to be Fully Functional
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EUDAMED Expected to be Fully Functional

May 11, 2023

EUDAMED is scheduled to be ‘fully functional’ sometime in Q2 2027. This means that all six modules of EUDAMED have been built out and EUDAMED as a whole has passed an independent audit. It would then be published in the Official Journal of the European Union (OJEU). After publication in the OJEU, the 6-24 month transition period begins.

 

There is a six-month transition period for the following modules: Actor, Vigilance, Clinical Investigation & Performance Studies and Market Surveillance. There is a 24-month transition period for the following modules: UDI/Device and Notified Body & Certificates modules.

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