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Extensive EU Medtech Regulatory Survey Reveals Scale Of MDR Hurdles And Where Problems Lie

18 Jul 2022

MedTech Europe says solutions are still urgently needed to ensure the MDR is on course and warns that 50% of companies are deprioritizing the EU as launch market, potentially denying EU citizens vital health care.

Climbing_Team — There is still a long and difficult MDR compliance journey ahead

Medical Device Regulation certificates have not been issued yet for over 85% of the more than 500,000 devices previously certified under the Medical Devices Directive or the Active Implantable Medical Devices Directive. Only 69,239 devices have been certified to the MDR in the past three years.

That is the shocking figure just released by MedTech Europe, the EU’s largest medtech industry association, in a survey...