A laboratory making lower-risk in-house IVDs (Classes 1 to 3) must list them all for the Secretary on the approved form, and must add any assay first made during a financial year by 1 July following or, if later, within 20 working days of first making it. It must hold NATA accreditation (or accreditation from a body the Secretary has determined) to ISO 15189 or ISO/IEC 17025, and must meet the NPAAC Requirements for the Development and Use of In-house IVDs. On an authorised person's request (with at least 20 working days to respond) it must give the quality documentation (objectives, organisation and monitoring, design controls and specifications, standards and risk analysis, connection evidence, tissue statement, clinical evidence, information supplied, production, purchasing and identification procedures, tests and calibration traceability, post-production review) with design and manufacturing data, and arrange tests. It must keep a post-marketing system that reviews experience, applies corrective action and notifies the Secretary promptly of information that might lead or have led to death or serious deterioration.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.