DIN EN ISO 20916:2024-07

This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. This document is specific for IVD medical devices and therefore uses definitions and concepts that are appropriate for IVD medical devices. This document identifies the principles that underpin clinical performance studies and specifies general requirements. The document is not intended to describe whether the technical specifications of the IVD medical device in question are adequately addressed by the clinical performance study. This document has been prepared by Technical Committee ISO/TC 212 "Clinical laboratory testing and in vitro diagnostic test systems" and adopted by Technical Committee CEN/TC 140 "In vitro diagnostic systems" (secretariat: DIN, Germany). Working Committee NA 176-08-08 AA "Quality management in medical laboratories" at DIN Standards Committee Medicine (NAMed) is responsible for this standard.