Setting the scene for EU reference labs for high-risk diagnostics

On 17 June 2022, the European Commission adopted two implementing acts to lay the groundwork for EU reference laboratories for high-risk diagnostics. The acts set out detailed rules on tasks and criteria for the labs and on the fees they can levy from notified bodies and Member States. For more information on next steps with the EU reference labs, please see the Joint Implementation and Preparedness Plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices.