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EUDAMED gradual roll-out

Here is the summary of decisions taken :
• the UDI/Device module will be released in Production in September 2021. Voluntary use is possible and workable.
• the NBs and Certificates module will be released in Production in September 2021 with the exception of the CECP and the Mechanism for scrutiny, which will remain in playground.
• the Vigilance and CI/PS modules will not be released in Production until EUDAMED is fully functional to avoid the risk of a non-harmonised use of the modules (only available in Playground).
• the Market surveillance module could be released in Production before EUDAMED is fully functional (still in development). Will depend of time period between development of this module and the full functionality of EUDAMED.

 

By | 2021-07-09T09:48:52+00:00 July 9th, 2021|news|0 Comments

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