Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p35
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 35/43)
Character Range: 430039–432791

device complies with the applicable provisions of the essential principles;
 (b) a general description of the kind of device;
 (c) details of the design specifications for the kind of device, including:
 (i) any medical device standard that has been applied to the kind of device; and
 (ii) the results of the risk analysis carried out; and
 (iii) if no medical device standard, or part only of such a standard, has been applied to the kind of device—the solutions adopted to ensure that each device of that kind complies with the applicable provisions of the essential principles;
 (d) for a kind of device that is intended by the manufacturer to be connected to another device—evidence demonstrating that:
 (i) the kind of device will comply with the applicable provisions of the essential principles when it is connected to the other device; and
 (ii) both devices are being used for their intended purposes;
 (e) a statement indicating whether or not the kind of device contains viable tissues, cells or substances of human or animal origin;
 (f) the results of any calculations, investigations, technical tests, or any other tests, carried out by the manufacturer in relation to the kind of device;
 (g) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
 (h) a copy of the information to be provided with the kind of device (if any).
 (3) The technical documentation must also contain information about the method or methods of manufacture of the kind of device.

6B.5  Post‑marketing system
 (1) The manufacturer of a Class 4 in‑house IVD medical device must establish, and keep up‑to‑date, a post‑marketing system for use for a device of that kind.
 (2) The post‑marketing system must require the manufacturer to:
 (a) systematically review experience gained in the post‑production phase for devices of that kind; and
 (b) implement appropriate means to apply any necessary corrective action for the design or production of those devices; and
 (c) notify the Secretary as soon as practicable after becoming aware of information relating to any of the following that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health:
 (i) any malfunction or deterioration in the characteristics or performance of the kind of device;
 (ii) any inadequacy in the design, production, labelling, instructions for use or advertising materials of the kind of device;
 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the kind of device.

6B.6  Declaration of conformity
 (1) The manufacturer of a Class 4 in‑house IVD medical device to which these conformity assessment