Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-15: Essential principle 15: IVD devices must have analytical and clinical performance that supports the intended use, address accuracy, precision, sensitivity, specificity, stability, interference and measurement uncertainty, assure calibrator traceability, allow users to verify performance, and make self-tests robust and easy to use

What does sch1-15 require?

An IVD's analytical and clinical performance must be good enough for the use the manufacturer claims, established by sound science and engineering, and the design must deal, as relevant, with trueness and precision, sensitivity and specificity, stability, known interferents and the uncertainty of measurement. Where results depend on calibrators or control materials, the quality management system must secure the metrological traceability of the values given to them. As far as reasonably practicable the user must be able to check at the time of use that the device will perform as intended. A self-test IVD must perform suitably given lay users' skills, means and the variation expected in technique and environment, its information and instructions must be easy to understand and apply, and its design must reduce the risk of error in use, sample handling and reading results.