Valid clinical association (MDR) / scientific validity (IVDR)

MDCG 2020-1 makes valid clinical association one of the three parts of clinical evidence for medical device software, together with technical performance and clinical performance. It asks whether the output is clinically meaningful, which literature and clinical guidelines often support.

Means the association of an MDSW output with a clinical condition or physiological state.

MDCG 2020-1, Section 3.3, Definitions (derived from IMDRF/SaMD WG/N41FINAL:2017)