EU Reference Laboratories Designated

On December 5, 2023, the European Commission implemented an act designating 5 EU Reference Laboratories (EURLs) for in vitro diagnostic medical devices (IVDs). These EURLs will handle the conformity assessment of high-risk (class D) IVDs and perform advisory tasks. They cover categories such as Hepatitis and retroviruses, Herpesviruses, Bacterial agents, and Respiratory viruses causing life-threatening diseases.

The act outlines transitional arrangements for the EURLs to form a network, harmonize working methods, and allows manufacturers and notified bodies to adapt processes for EURL testing. EURLs are set to commence their conformity assessment tasks on October 1, 2024.

The act includes provisions to minimize disruption to ongoing processes, with performance verification by EURLs applied to new applications post-transition, and batch testing of already CE-marked devices initiated after the transitional period for effective control.