Several Schedule 4 Part 2 exemptions are conditional. Patient-matched device sponsors had to notify the Secretary before 1 November 2024 of each kind intended for supply on or after 1 July 2029 with sponsor, manufacturer, nomenclature code, class and unique product identifiers. Clinical decision support software that only supports a recommendation to a health professional and does not process images or signals must meet the essential principles, have conformity assessment applied at all times and its manufacturer must answer the Secretary within 20 working days on compliance. Other items set conditions for system or procedure packs, Class 1 to 3 and Class 4 in-house IVDs in specified settings, surgical loan kits, therapeutic vaping devices (sponsor notice before import or first supply and supporting evidence), Class 4 in-house IVDs screening donors for SARS-CoV-2 (made or supplied only by an accredited pathology laboratory, records kept, essential principles and conformity assessment from 1 July 2025), and, from September 2026, devices used by Defence medical practitioners (item 2.20). The person relying on an exemption must hold evidence that each condition is met; breach removes the exemption.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.