Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:3:p9
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 3 (pt 9/43)
Character Range: 363441–366253

(3) in relation to the type.
 (3) For paragraph (2)(b), the documentation must include adequate information about the design, production process and intended performance of the type, and must include, in particular, the following:
 (a) a general description of the type, and of any variants of the type that the manufacturer plans to manufacture;
 (b) diagrams or drawings of the design of the type, including diagrams or drawings of any components, sub‑assemblies or circuits of the type;
 (c) any descriptions or explanations that are necessary to enable the diagrams or drawings mentioned in paragraph (b), or the intended operation of the type, to be properly understood;
 (d) the proposed method or methods of manufacture of the type;
 (e) if the type is intended by the manufacturer to be supplied in a sterile state—a description of the method used to sterilise the type;
 (f) details of each medical device standard or conformity assessment standard that has been applied, wholly or in part, to the type;
 (g) if no medical device standard or conformity assessment standard has been applied, or such a standard has been only partly applied, to the type—descriptions of the solutions adopted to ensure that the type complies with the applicable provisions of the essential principles;
 (h) the results of any design calculations, risk analyses, investigations, technical tests, or any other tests, carried out in relation to the type;
 (i) a statement indicating whether or not the type incorporates, or is intended to incorporate, as an integral part, a substance mentioned in clause 7.4 of the essential principles, and, for a type that does so, data derived from tests conducted in relation to the type and the substance, and their interaction;
 (j) 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;
 (ja) for an IVD medical device—a statement indicating whether or not the device contains viable tissues, cells, or substances of human or animal origin;
 (k) a copy of the clinical evidence, in relation to the kind of device, required by the clinical evaluation procedures;
 (l) a copy of the information to be provided with the type.
 (4) The manufacturer must make available to the Secretary or the Australian conformity assessment body for examination:
 (a) a sample of the type; and
 (b) on request from the Secretary or the Australian conformity assessment body, additional samples of the type.
 (5) If the type is intended by the manufacturer to be connected to another medical device, the manufacturer must, on request from the Secretary or the Australian conformity assessment body, make available to