{"standard":"EN ISO 13485","listings":[{"edition":"EN ISO 13485:2016","list":"ivdr","list_name":"IVD Regulation","jurisdiction":"EU","title":"Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1195-20260617"},{"edition":"EN ISO 13485:2016","list":"mdr","list_name":"Medical Devices Regulation","jurisdiction":"EU","title":"Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617"},{"edition":"EN ISO 13485:2016","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"30/09/2021","source":"https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices"},{"edition":"EN ISO 13485:2016","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"17/01/2026","source":"https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices"},{"edition":"EN ISO 13485:2016","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Medical devices - Quality management systems - Requirements for regulatory purposes","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"},{"edition":"EN ISO 13485:2016","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-medical-devices"},{"edition":"EN ISO 13485:2016","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Medical devices - Quality management systems - Requirements for regulatory purposes","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-medical-devices"},{"edition":"EN ISO 13485:2016","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)","annex":"S.I. 2002/618","pc_start":"17/01/2026","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-medical-devices"}],"events":[{"date":"2022-05-12","type":"modified","ref":"EN ISO 13485:2016","leg_slug":"ivdr","leg_name":"IVD Regulation"},{"date":"2022-01-05","type":"added","ref":"EN ISO 13485:2016","leg_slug":"mdr","leg_name":"Medical Devices Regulation"}],"generated":"2026-08-16 23:54 UTC"}