17 notified bodies have filed for IVDR designation
In spite of the EU having postponed new regulation pertaining to in vitro diagnostic medical devices, there is still a huge lack of notified bodies designated to authorize new products.
by ANDREAS LØNSTRUP, translated by daniel pedersen
In December 2021, the European diagnostic industry breathed a sigh of relief, as the EU backed an extended implementation period for the new In Vitro Diagnostic Medical Devices Regulation (IVDR).
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