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.

Photo: Damien Meyer/AFP/Ritzau Scanpix

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).

The new rules require around 80 percent of IVDs to be approved by a notified body, compared to 8 percent under the current rules, but the industry warns of a shortage in the notified body capacity, as reported by media Medtech Dive.

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