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

06 Oct 2021

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.

Lightspring/Shutterstock.com — 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...