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Landmark Date Highlights Major Problems In Implementing IVDR As Well As MDR

 
• By Amanda Maxwell

There may have been a significant increase in the amount of regulatory activity at EU level of late, but the medtech industry remains alarmed at the lack of readiness of the regulatory system, and calls for an urgent focus on IVDs.

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Devoting the same level of attention and energy to the EU IVD Regulation (IVDR) as to the Medical Device Regulation (MDR) is long overdue. That is the view of the EU’s largest medtech industry association, MedTech Europe, in a statement released to mark the half-way point of the IVDR’s five-year transition period and the six-month countdown to the MDR.

MedTech Europe notes that the IVDR will bring an estimated eight-fold workload increase to IVD notified bodies.

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More from Geography

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