Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p38
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 38/43)
Character Range: 437619–440367

the statement with the device; and
 (b) to prepare and keep up‑to‑date particular documentation in relation to the device.

7.2  Custom‑made medical devices
 (1) This clause applies to a custom‑made medical device.
 (2) The manufacturer of the device must prepare a written statement in relation to the device including the following:
 (a) the name and business address of the manufacturer;
 (b) sufficient information to enable the user to identify the device or, if relevant, the contents of packaging;
 (c) a statement to the effect that the device is intended by the manufacturer to be for the sole use of a particular patient or health professional;
 (d) the name of the individual in relation to whom the device is intended to be used;
 (e) the name and business address of the health professional who made the request for the device;
 (f) the particular design characteristics of the device as specified by the health professional who made the request for the device;
 (g) a statement to the effect that the device complies with the applicable provisions of the essential principles or, if the device does not comply with all applicable provisions of the essential principles, a statement explaining which provisions of the essential principles the device does not comply with and the reasons for the non‑compliance.
 (3) The statement must:
 (a) be signed by a person authorised by the manufacturer of the device; and
 (b) set out the name and position of the person signing the statement; and
 (c) state the date when the statement is signed.
 (3A) The manufacturer must provide a copy of the statement with the device.
 (4) The manufacturer must prepare, and keep up‑to‑date, documentation in relation to the device, including information in relation to the design, production and intended performance of the device.
 (5) The manufacturer must take all measures necessary to ensure that the process used to manufacture the device results in the device complying with the documentation mentioned in subclause (4).
 (6) The manufacturer must notify the Secretary as soon as practicable after becoming aware of:
 (a) information relating to:
 (i) any malfunction or deterioration in the characteristics or performance of the device; or
 (ii) any inadequacy in the design, production, labelling or instructions for use of the device; or
 (iii) any use in accordance with, or contrary to, the use intended by the manufacturer of the device;
  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; or
 (b) information relating to any technical or medical reason for a malfunction or deterioration of a kind mentioned in paragraph (a) that has led the