EU Is Heading For Partial IVD Market Collapse, Recent Analysis And Figures Suggest
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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Following a busy year for point of care diagnostics, the industry is facing a period of consolidation. The drive for new technologies is being countered by regulatory and financial issues.
The pressing circumstances created by the ongoing COVID-19 pandemic has resulted in the commission not only accepting compliance delays for some IVDs, but also longer transitional provisions than expected.
All eyes were on the European Commission in January as it edged closer to adopting new legislation that will see the Medical Device Regulation transition deadlines extended.