On January 27 the MDCG published 2022-2 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs).
This guidance describes the approach by which 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, such as post-market performance follow-up.
The target audience of this document is IVD manufacturers, investigators and study sponsors. This document is also intended to inform regulators, notified bodies and other stakeholders when considering clinical evidence provided by manufacturers.
The document can be downloaded in our library
Source: European Commission