Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 2/40)
Character Range: 40188–43044

more classification rules apply to the medical device, the device has the highest level of classification applying under the applicable classification rules.
 (8) For classification of a medical device system or a medical device procedure pack, medicines are not considered to be integral to the system or the procedure pack.
 (9) For a system or procedure pack that contains both the devices mentioned in subregulation (11), that have different levels of classification under the table in regulation 3.1, the classification level of the system or procedure pack is that of the highest class of device mentioned in subregulation (11).
 (10) A system or procedure pack that contains both of the devices mentioned in subregulation (11), that have the same level of classification under the table in regulation 3.1, is classified according to its primary intended purpose.
 (11) For subregulations (9) and (10), the devices are:
 (a) an IVD medical device; and
 (b) a medical device that is not an IVD medical device.

Division 3.2—Conformity assessment procedures

3.4  Conformity assessment procedures (Act s 41DA)
 (1) For section 41DA of the Act, the requirements relating to the obligations of manufacturers of medical devices (the conformity assessment procedures) are set out in Schedule 3.
 (2) The application of the conformity assessment procedures to a medical device, or a kind of medical device, is set out in this Division.
 (3) Subregulation (4) applies to the following devices:
 (a) Class IIb medical devices;
 (b) Class 3 IVD medical devices;
 (c) Class IIa medical devices;
 (d) Class 2 IVD medical devices;
 (e) Class I medical devices;
 (f) Class 1 IVD medical devices.
 (4) The manufacturer of a device mentioned in subregulation (3) must apply to the device appropriate conformity assessment procedures, being:
 (a) the minimum conformity assessment procedures that are applicable, under this Division, to the device; or
 (b) if the manufacturer prefers, conformity assessment procedures that are applicable, under this Division, to a medical device that is classified at a higher level than the device concerned.

3.5  Powers and functions of Secretary in relation to conformity assessment
 (1) For the purpose of applying conformity assessment procedures to a kind of medical device, a power or function of the Secretary, in relation to an assessment to be conducted under the procedures, may be exercised or performed at the place where the manufacturer is located, and at the manufacturing site, by a body or authority that the Secretary is satisfied has the authority and expertise to exercise that power or perform that function.
 (2) If, under the conformity assessment procedures, the manufacturer of the kind of medical device is required to give information of a kind mentioned in paragraph 41MP(2)(a) or (b) of the Act to the