Document ID: chunk:federal_register_of_legislation:F2025C00021:clause:1_15
Version: federal_register_of_legislation:F2025C00021
Segment Type: clause
Provision Reference: sch 1 cl 15
Character Range: 310971–312597

15  Principles applying to IVD medical devices only
 (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 IVD medical 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 IVD medical 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 IVD medical 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 IVD medical 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 IVD medical device for self‑testing must be easy for the user to understand and apply.
 (7) An IVD medical device for self‑testing must be designed and manufactured in a way that reduces, to the extent practicable, the risk of error in the use of the device, the handling of the sample and the interpretation of results.