Private Health Journal

Glossary · Evaluation and safety

Clinical Validation

clinical evaluation

Clinical Validation

Regulatory

Demonstration that a system's output achieves the intended clinical effect in the intended population and setting.

Distinct from technical accuracy: a model can score well on a held-out set and still change nothing, or harm, in practice.

Context

SourceRegulation (EU) 2017/745 (MDR), Annex XIV; MDCG 2020-1