{"standard":"EN ISO 14971","listings":[{"edition":"EN ISO 14971:2012","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)","annex":"S.I. 2002/618","pc_start":"01/01/2021","restriction":"","withdrawal":"","source":"https://www.gov.uk/government/publications/designated-standards-in-vitro-diagnostic-medical-devices"},{"edition":"EN ISO 14971:2012","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)","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 14971:2019","list":"ivdr","list_name":"IVD Regulation","jurisdiction":"EU","title":"Medical devices – Application of risk management to medical devices (ISO 14971:2019)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1195-20260617"},{"edition":"EN ISO 14971:2019","list":"mdr","list_name":"Medical Devices Regulation","jurisdiction":"EU","title":"Medical devices – Application of risk management to medical devices (ISO 14971:2019)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1182-20260617"},{"edition":"EN ISO 14971:2019","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"Medical devices – Application of risk management to medical devices","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 14971:2019","list":"uk-medical-devices","list_name":"UK Medical Devices (designated)","jurisdiction":"UK","title":"Medical devices – Application of risk management to medical devices","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":"2022-05-17","type":"added","ref":"EN ISO 14971:2019","leg_slug":"mdr","leg_name":"Medical Devices Regulation"},{"date":"2022-05-12","type":"added","ref":"EN ISO 14971:2019","leg_slug":"ivdr","leg_name":"IVD Regulation"}],"generated":"2026-08-16 23:54 UTC"}