EU Now Has 20 MDR Notified Bodies With Latest Designation And ‘More To Come’
At last, the EU has reached its milestone of having 20 notified bodies designated under the Medical Device Regulation. And Finland now boasts two.
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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.
The latest update in the Medical Device Regulation page of the European Commission's Nando database represents the 18th listing under the new regulation. Numbers are rising slowly.
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.