EU MDR Notified Body Designations Could Soar By A Third By End Of 2021
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.
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At last, the EU has reached its milestone of having 20 notified bodies designated under the Medical Device Regulation. And Finland now boasts two.
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.
The EU's Notified Bodies Operations Group's just issued a best-practice guide on the designation and notification of conformity assessment bodies under the MDR and IVDR. It makes for sobering reading.