According to a press release1, the European Parliament and the Council adopted the In Vitro Diagnostic Medical Devices Regulation on 20 December 2021 following a proposal by the European Commission in October 2021 for a progressive roll-out of the Regulation to prevent disruption in the supply of 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 (this was reported in Safety and EMC, November 2021, Issue 179).
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