EU Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation

Today, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation to prevent disruption in the supply of these essential healthcare products. The unprecedented challenges of the COVID-19 pandemic have diverted resources from Member States, health institutions and economic operators towards addressing the crisis, thereby hampering the capacity to comply on time with the changes introduced.

Stella Kyriakides, Commissioner for Health and Food Safety, said: “The COVID-19 pandemic has shown how essential it is to have accurate diagnostics and a robust regulatory framework for in vitro medical devices. Shortages at this point in time are unthinkable. The pandemic has imposed unprecedented challenges also for our medical devices industry. With more time to prepare for the application of the EU new rules, we will ensure there is a continuous supply of essential in vitro diagnostic medical devices on the market, while not compromising on safety. I call on all manufacturers to prepare for certification under the new Regulation as soon as possible and not wait until the end of the transition period.”

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