EU MDR Compliance: Surviving the Notified Body Capacity Shortage in Europe

Medical Device Global Market Access · Mar 3, 2026 · 3m

This episode delves into the critical capacity crisis among Notified Bodies under the EU's Medical Device Regulation (MDR). We explore how the stringent requirements of the MDR, combined with a reduction in the number of designated Notified Bodies, have created a massive bottleneck for certifying new and legacy medical devices. We discuss the significant risk this poses to manufacturers, who face the possibility of their products being forced off the market as old certificates expire, and examine the European Commission's legislative response to extend the transition deadlines. - What is the…