{"standard":"EN ISO 18113-5","listings":[{"edition":"EN ISO 18113-5:2011","list":"uk-in-vitro-diagnostic-medical-devices","list_name":"UK IVD (designated)","jurisdiction":"UK","title":"In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)","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 18113-5:2024","list":"ivdr","list_name":"IVD Regulation","jurisdiction":"EU","title":"In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)","annex":"ANNEX","source":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02021D1195-20260617"}],"events":[{"date":"2026-01-30","type":"added","ref":"EN ISO 18113-5:2024","leg_slug":"ivdr","leg_name":"IVD Regulation"}],"generated":"2026-08-16 23:54 UTC"}