MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) – January 2022

To demonstrate compliance of its IVD with the applicable general safety and performance requirements, according to Regulation (EU) 2017/746, the manufacturer must provide a sufficient level of clinical evidence, appropriate to the device characteristics and its intended purpose (IVDR Article 56(1)). MDCG 2022-2 addresses the performance evaluation of IVDs and, more specifically, how to collect, generate and document the data supporting the compliance of the device, both before placing the device on the market or putting it into service and also as part of the post-market performance follow-up.

For the purpose of international harmonisation, this document takes into account some of the concepts described in the Global Harmonisation Task Force guidance documents (e.g. SG5/N7:2012).