{"standard":"EN ISO 20916","listings":[{"edition":"EN ISO 20916:2024","list":"ivdr","list_name":"IVD Regulation","jurisdiction":"EU","title":"In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1195-20260617"},{"edition":"EN ISO 20916:2024","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice","annex":"S.I. 2002/618","pc_start":"17/01/2026","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices"}],"events":[{"date":"2024-10-09","type":"added","ref":"EN ISO 20916:2024","leg_slug":"ivdr","leg_name":"IVD Regulation"}],"generated":"2026-08-16 23:54 UTC"}