The MDCG (Medical Device Coordination Group) has recently published the MDCG 2022-2 Guidance which outlines the general principles of clinical evidence and provides recommendations to establish a continuous process for evaluating the performance of In Vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.
This guidance describes the approach by which the collection, generation, and documentation of supporting data for an IVD may be conducted prior to the placing on the market or putting into service. As the performance evaluation will be updated throughout the life cycle of an IVD, this document also addresses principles related to post-market surveillance and post-market performance follow-up.
This document is intended for IVD manufacturers, investigators and study sponsors, as well as regulators. It is also intended to inform notified bodies and other stakeholders when considering clinical evidence provided by IVD manufacturers.