Glossary · Evaluation and safety
Clinical Validation
clinical evaluation
Clinical Validation
RegulatoryDemonstration 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