Technical performance (MDR) / analytical performance (IVDR)

MDCG 2020-1 makes technical performance (analytical performance for IVD software) one of the three parts of clinical evidence for software, alongside valid clinical association and clinical performance. It is shown through verification and validation on representative input data.

Capability of a MDSW to accurately and reliably generate the intended technical/analytical output from the input data.

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