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 lose their certification under the previous directives and those that have been recertified under the new regulations. The survey shows that while applications under MDR have increased from 1,661 in 2020 to 14,539 in 2023, the number of certificates issued in that time has grown from 180 to 4,873, leaving a gap of nearly 10,000 products awaiting certification…
