MDR And IVDR – Similar Step Ups, Varying Commercial Impacts

Medtech Insight spoke to the CEOs of two companies that recently had very different experiences with the new European IVDR and MDR regulations to gauge their thoughts on any potential commercial impacts.

gears for rules and regs
• Source: Shutterstock

Implementation of the EU’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) has hardly been smooth sailing.

In contrast to the previous Medical Devices Directive and In Vitro Devices Directive, device manufacturers have been left confused and...

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