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EU Is Heading For Partial IVD Market Collapse, Recent Analysis And Figures Suggest

 
• By Amanda Maxwell

With just six notified bodies designated under the IVD Regulation, and amidst repeated warnings of insufficient auditing capacity, the EU could lose between three-quarters and over a half of its IVDs, a recent survey warns.

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Many products will not survive the IVDR challenges

In a best-case scenario 61% of today’s IVDs will be certified by the 26 May 2022 IVD Regulation deadline, and in a worst-case scenario only 24% will be, a survey recently conducted by EU medtech industry association MedTech Europe found.

The conditions for this crisis situation have mainly arisen because, while just 8% of IVDs need a notified body certificate...

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More from Geography

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• By Elizabeth Orr

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• By Sue Sutter

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