Non-clinical data

Bench, animal and simulation data are typical non-clinical data. In the MDCG guidance on orphan devices and orphan IVDs, such data may play a larger role when clinical data are scarce, but the manufacturer still has to justify why the evidence is sufficient.

Any relevant data that does not meet the MDR definition of clinical data

MDCG 2024-10, Section 1, Abbreviations and terminology

Any relevant data that does not meet the IVDR definition of data on clinical performance

MDCG 2026-6, Section 1, Abbreviations and terminology