MDGC Publishes Guidance on Performance Studies for IVDs

The Medical Device Coordination Group (MDCG) has published a Q&A document providing guidance around performance studies for in vitro diagnostic devices (IVDs).

The guidance provides clarity concerning the differing purposes of clinical performance studies and analytical performance studies. It also provides direction concerning the circumstances in which a performance study should be the subject of an application to, or notification to, competent authorities.