Team-NB produced a Position Paper on measures for class D IVD in the absence of EU Reference Laboratories as a result of the IVD working group’s efforts. During the General Assembly meeting, a sizable majority of the members approved the paper.
The inclusion of EURLs in the performance verification of class D devices may be one of the components of the regulatory infrastructure specifically designed for the conformity assessment of class D devices. The European Commission issued a call for applications for EURLS in various categories of devices in June 2022; designation is anticipated for Q3 2023, while it is not yet clear if EURLS will be approved for all of these categories.
The purpose of this discussion paper is to offer a framework for Notified Bodies (NB) to use in order to verify class D IVD medical devices in the absence of approved EU Reference Laboratories (EURLs).
Both the verification during the Technical Documentation review prior to certification and of produced goods following certification are included in the scope.
However, it is fully up to an NB to choose what / which approaches and solutions are employed, if they would like to progress Class D applications in the absence of EURLs. This position paper discusses potential solutions and/or interim implementation measures.