Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p4
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 4/43)
Character Range: 350752–353535

of the risk analysis carried out; and
 (C) if no medical device standard or conformity assessment standard, or part only of such a standard, 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 kind of 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 kind of device incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, and, for a device that will do so, data derived from tests conducted in relation to the device and the substance, and their interaction;
 (vi) a statement indicating whether or not the device, other than an IVD medical device, contains tissues, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of microbial or recombinant origin;
 (via) for an IVD medical device—a statement indicating whether or not the device contains viable tissues, cells, or substances of human or animal origin;
 (vii) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
 (viii) a copy of the information to be provided with the kind of device;
 (d) the inspection and quality assurance techniques to be applied in the production of the kind of medical device to which the system is to be applied, including, in particular, information about the following:
 (i) the processes and procedures to be used (particularly in relation to sterilisation) 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 kind of 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 kind of medical device to which the system is to be applied, including, in particular, 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 in relation to the kind of medical device to which the quality management system has