Medical Device Regulation – Australia

Meeting the Essential Principles – Design and construction

Principle 15 – IVD Medical Device

1. An IVD medical device must be designed and manufactured in a way in which the analytical and clinical characteristics support the intended use, based on appropriate scientific and technical methods.
2. An IVDmedical device must be designed in a way that addresses accuracy, precision, sensitivity, specificity, stability, control of known relevant interference and measurement of uncertainty, as appropriate.
3. If performance of an IVDmedical device depends in whole or part on the use of calibrators or control materials, the traceability of values assigned to the calibrators or control material must be assured through a quality management system.
4. An IVDmedical device must, to the extent reasonably practicable, include provision for the user to verify, at the time of use, that the device will perform as intended by the manufacturer.
5. An IVDmedical device for self-testing must be designed and manufactured so that it performs appropriately for its intended purpose, taking into account the skills and the means available to users and the influence resulting from variation that can reasonably be anticipated in the user’s technique and environment.
6. The information and instructions provided by the manufacturer of an IVDmedical device for self-testing must be easy for the user to understand and apply.