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.
Industry’s message may continue in a similar vein, but the urgency over the implementation of the EU IVDR has grown to a point where it is desperate for some solution to what it sees as an impending disaster for IVDs in the EU.
The EU’s Medical Device Regulation applies in just over a month’s time and the IVD Regulation in just over a year. But the standards underpinning them are way behind. Will they get the green light at last?