The Impact of the Medical Device Directive to Medical Device Regulation Transition on Early Clinical Testing of Cardiovascular Devices

Abstract

On May 26, 2021, the European Union (EU) updated its regulatory requirements for medical devices by implementing the Medical Device Regulations (MDR).1 Although the change to the MDR system was driven by important shortcomings in the EU regulatory system, the transition has been chaotic and has a large impact on cardiovascular devices in development as well as on approved devices. This manuscript examines the background behind these changes and their impact.