Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p32
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 32/43)
Character Range: 422227–425026

is to be applied, including the following:
 (i) details of the processes, systems and measures used for controlling, monitoring and verifying that, at each stage of the design process, the device complies with the applicable provisions of the essential principles;
 (ii) a general description of the device;
 (iii) details of the design specifications for the device, including:
 (A) any medical device standard that has been applied to the device; and
 (B) the results of the risk analysis carried out; and
 (C) if no medical device standard, or part of it, has been applied to the device—the solutions adopted to ensure that each device complies with the applicable provisions of the essential principles;
 (iv) for a device that is intended by the manufacturer to be connected to another device—evidence demonstrating that the device will comply with the applicable provisions of the essential principles when it is connected to the other device and both devices are being used for their intended purposes;
 (v) a statement indicating whether or not the device contains viable tissues, cells or substances of human or animal origin;
 (vi) a copy of the clinical evidence, in relation to the device, required by the clinical evaluation procedures;
 (vii) a copy of the information to be provided with the device, when relevant;
 (d) the inspection and quality assurance techniques to be applied in the production of the medical device to which the system is to be applied, including information about the following:
 (i) the processes and procedures to be used and the documents relating to those processes and procedures;
 (ii) the procedures to be used for purchasing goods or services in relation to the production of the device and the documents relating to those procedures;
 (iii) product identification procedures to be prepared and kept up‑to‑date from drawings, specifications or other documents at each stage of production;
 (e) the tests or trials to be carried out before, during and after production of the medical device to which the system is to be applied, including information about:
 (i) the frequency with which the tests or trials are to be carried out; and
 (ii) the equipment (including the traceability of the calibration of the equipment) used, or to be used, to carry out the tests or trials;
 (f) the system for reviewing experience gained in the post‑production phase for the medical device to which the quality management system has been applied, and the means by which any necessary corrective action will be applied to the design or production of such devices.
 (3) If any inspections or tests are carried out by an authorised person in relation to the manufacturer's premises, or medical devices produced by the manufacturer, the manufacturer may ask the authorised