Europe – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach

Notified body (NB) capacity has risen significantly in recent years as the number of designations has increased; however, some manufacturers have yet to transition their products to the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which experts say could lead to devices being pulled from the EU market.

According to a recent survey by notified body industry group Team-NB, there is a growing gap between products that are set to