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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.

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