What does 8.05 require?

Adverse events involving an IVD, whether bought or developed in-house, are notified to the TGA inside the regulator's timeframes, in its format and according to its rules.

Australia National Pathology Standards (First Edition...

Other controls in Standard 8: Medical devices – Australia National Pathology Standards (First Edition 2027)

8.01 Medical device implementation and replacement: ensure devices are on the ARTG or, if developed in-house, validated to ISO 15189 and compliant with NPAAC and regulatory requirements; consult and manage change; assess suitability for patient care; evaluate and verify against the manufacturer's claimed specifications; validate performance with recognised reference standards or methods; complete calibration, quality control and quality assurance before implementation; manage ageing or underperforming devices; and monitor and periodically review performance with revalidation after significant change, new evidence or identified risk
8.02 Medical device use: use devices for their intended purpose per the manufacturer's instructions for use, classify commercial IVDs used outside their intended purpose (such as unspecified specimen types) as in-house IVDs, and comply with the relevant NPAAC standards and TGA requirements
8.03 Medical device maintenance: keep a current and complete device inventory, store devices per the manufacturer's instructions, use in-date reagents and consumables per the instructions for use, perform planned maintenance and repair per the instructions using qualified personnel, performance-test devices after maintenance and repair, and maintain each device's maintenance and repair log
8.04 In-house IVD medical devices: validate clinical and analytical performance, comply with TGA requirements for in-house IVDs, assess against the NPAAC in-house IVD requirements, demonstrate through validation that performance is fit for purpose and supports safe care, hold documented validation evidence covering methodology, performance characteristics and acceptance criteria, and keep in-house IVDs under ongoing quality assurance
8.06 IVD software and AI governance and implementation: ensure commercial IVD software is on the ARTG and in-house IVD software including diagnostic AI is managed as an in-house IVD under NPAAC, TGA and best practice requirements; govern selection, implementation and use within the clinical governance and risk framework including privacy, cybersecurity and data integrity; undertake a privacy impact assessment covering third-party processing; confirm performance for intended use, population and context through acceptance testing and commissioning; evaluate AI performance before clinical use and monitor it over time; and evaluate performance on data relevant to the intended population where training data are not Australian
8.07 IVD software and AI clinical use and oversight: use IVD software and AI only for their intended purpose and with evidence of clinical benefit or improved accuracy, efficiency or decision-making; train the workforce to use them, understand limitations and apply clinical judgement to AI-assisted outputs; monitor that staff stay within role and scope; define responsibility for reviewing, correcting and approving AI-assisted results within the supervision framework; communicate AI use to patients transparently where clinically appropriate without diminishing the medical practitioner's responsibility; and document, investigate and report significant AI incidents

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.

MCP endpoint All Australia National Pathology Standards (First Edition 2027) controls