Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation

Thanks to the adoption by the European Parliament and the Council, the In Vitro Diagnostic Medical Devices Regulation which will apply as from 26 May 2022, can now be progressively rolled out. In the context of the COVID-19 pandemic member states, health institutions and economic operators redeployed financial and other resources to address the unprecedented challenges of the crisis. By doing so, they delayed the implementation of the In Vitro Diagnostic Medical Devices Regulation of 2017, which introduced certain requirements for medical devices and a stronger role for so-called conformity assessment bodies. To prevent disruption of supply of essential healthcare products as a result of these delays, the Commission proposed in October a progressive roll-out of the Regulation of 2017. The adoption of this proposal by the co-legislators will keep the supply of these essential healthcare products flowing.

Welcoming the adoption, Health and Food Safety Commissioner Stella Kyriakides said: “In the midst of an unprecedented public health crisis, we cannot risk shortages of essential medical devices. Health systems and routine health services have been tested like never before. The pandemic has at the same time highlighted the vital need for accurate diagnostics and a resilient regulatory framework for in vitro medical devices.” The amending Regulation does not change any requirements of the original In Vitro Diagnostic (IVD) Regulation of 2017. It only changes the dates of application of some of these requirements for certain medical devices. More information is available in this press release.

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