Lobbying For A One-Year Delay To The EU IVDR: Solution Or Forlorn Hope?
The IVD Regulation is due to fully apply in May 2022. The necessary infrastructure looks unlikely to be ready in time. But industry faces a dilemma: will lobbying and pining hopes on a delay be the best use of its resources?
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The IVD Regulation is due to fully apply on 26 May 2022, but the infrastructure for manufacturers to demonstrate compliance and for notified bodies to perform their audits according to the new rules keeps being delayed.
Growing evidence demonstrates the one-year delay to the Medical Device Regulation, plus the expansion of the scope of products that could remain on the market beyond the MDR date of application, have simply pushed problems to 2024.
The European Commission’s just updated Rolling Implementation Plan for the MDR and IVDR shows delays in key structures for high-risk IVDs. Recent guidance clarifies how and when these products can still proceed to CE marking.