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EU’s Eudamed Database: Crucial To New Regs, But Will It Be Ready in Time?

 
• By Amanda Maxwell

The EU must have its new Eudamed database operating smoothly to support the implementation of the new IVD and Medical Device Regulations. But experience with its predecessor suggests progress may not always be straightforward.

Concern persists in the EU that the new Eudamed medical device database, which will underpin the forthcoming Medical Device and IVD Regulations, will not be up and running smoothly by the time the regulations start to operate.

The new database is supposed to go fully live in early 2020 if the current timetable proceeds as planned. But...

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