European Commission ‘Will Not Delay IVDR, Nor MDR Any Further’
It seems that the medical device and IVD industries are clutching at straws if they expect the European Commission to agree to further delays in the EU medtech regulations.
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Cries for the EU to pay more attention to IVDs are growing louder by the day. It is feared the EU IVD sector is heading for a crisis and safe products will have to be pulled from the market.
The medtech industry’s call for a one-year delay to the Medical Device Regulation and for EU-wide exceptions from usual medical device rules was granted recently. But not for IVDs, where the situation is described as “grim.”
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