With EU Notified Body Numbers Tumbling, How Do Manufacturers Ensure Seamless Transition To MDR?
Executive Summary
Device manufacturers in the EU are beginning to realize the extra volume of MDR/IVDR-related work that their pivotal market access partners, the notified bodies, will have to take on. With the regulations' three- and five-year transition period clocks ticking down already, manufacturers must make sure that business continuity is guaranteed – but it won't be easy.