Why The Humble Swab Could Be A Seriously Disruptive Element In The MDR And IVDR
Health care is about to suffer a major setback and some devices and IVDs are going to have to be held back from the market if the regulatory status of the humble swab is not sufficiently recognized and urgently addressed.
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There could be 28 notified body designations in total under the Medical Device Regulation by the end of 2021. But there is cause for concern over designations under the IVD Regulation, which are lagging far behind.
No one should underestimate the scale of the obstacles companies face trying to comply in time with the IVD Regulation by its 26 May 2022 deadline, especially now data is starting to emerge to highlight the size of the problem.
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.