This document provides guidance to manufacturers, notified bodies, expert panels, health institutions, and regulators on the clinical evidence requirements for orphan IVDs and for IVDs that have an orphan indication within the meaning of this guidance. The guidance is relevant to IVDs across all risk classes.
Particular attention is given to the clinical performance of orphan IVDs, which forms part of the clinical evidence and performance evaluation requirements stated in IVDR Chapter VI. Where relevant, the guidance should be read in conjunction with other MDCG guidance documents, in particular MDCG 2022-2 on general principles of clinical evidence for IVDs.