EU Is Heading For Partial IVD Market Collapse, Recent Analysis And Figures Suggest
Executive Summary
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.
You may also be interested in...
Point Of Care Diagnostics In 2022: New Technology But Old Problems
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.
European Commission Gives In On IVDR Delays: Proposal For New Transition Periods
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.
EU Regulatory Round-Up, January 2023: Cautious Optimism As New MDR Proposal Unveiled
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.