European Union Reference Laboratories for in vitro diagnostic medical devices

The involvement of European Union Reference Laboratories (EURLs) is a new requirement described in Article 100 of Regulation (EU) 2017/746 (IVDR) and concerns Class D in vitro diagnostic medical devices (IVDMDs). It is established in order to strengthen regulators’ oversight of these devices.

Several tasks, detailed in Article 100, are assigned to EURLs, the aim of this newsletter being to focus on the two main tasks described in points a) and b) with the implementation date of October 1st, 2024.