It had been set to come into effect on May 26, 2020, replacing the existing Medical Device Directive (MDD), but will now be scheduled for the same date next year.
This decision was taken to allow the European medtech industry to cope with the impact of the COVID-19 crisis.
GlobalData estimates that the MDR would have disrupted the approval process for many new medical innovations, as well as, the re-certification of existing devices. The postponement of these regulations is likely to have taken the pressure off many companies within the industry.
As the outbreak has heightened demands for certain devices, postponing the MDR ensures market disruptions for critical devices is limited.