ISO 20916 is a new ISO for clinical performance studies with in vitro diagnostic (IVD) medical devices published last year. This guideline fills the gap between ICH E6 (Good Clinical Practice [GCP] for pharma) and ISO 14155 (“GCP” for medical devices), thus defining a “new” concept – Good Study Practice (GSP) for IVDs.
Importantly, ISO 20916 defines GSP and provides a framework of what that means for clinical performance studies. The guideline describes how to plan, design, conduct, record, and report clinical performance studies that aim to assess the performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes. Moreover, it’s straightforward to read and contains easy-to-follow explanatory flowcharts and tables. We’ve found ISO 20916 to be an extremely helpful guideline and have used it in several of our ongoing projects at Scandinavian CRO.