Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p7
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 7/40)
Character Range: 53004–55760

that apply to the relevant classification.

Exception
 (1A) However, paragraphs (1)(a), (b) and (c) do not apply to a Class 1 in‑house IVD medical device, a Class 2 in‑house IVD medical device or a Class 3 in‑house IVD medical device.
Note: The conformity assessment procedures that must be applied to Class 1 in‑house IVD medical devices, Class 2 in‑house IVD medical devices or Class 3 in‑house IVD medical devices are the procedures mentioned in Part 6A of Schedule 3.
 (2) The conformity assessment procedures that must be applied to a medical device used for a special purpose are the procedures for medical devices used for a special purpose.
 (3) This subregulation applies to a system or procedure pack:
 (a) where each medical device included in the system or procedure pack is a medical device to which the relevant conformity assessment procedures have been applied; and
 (aa) if one or more medicines, biologicals or other therapeutic goods are included in the system or procedure pack:
 (i) if all of those medicines and biologicals are entered on the Register; and
 (ii) if all of those other therapeutic goods are entered on the Register, or are covered by subregulation 12(1) of the Therapeutic Goods Regulations 1990 to the extent that they are tampons, menstrual cups or disinfectants; and
 (iii) if there has been no modification of the packaging of any of those medicines, biologicals or other therapeutic goods; and
 (iv) if there has been no modification of any of those medicines, biologicals or other therapeutic goods; and
 (b) that has been put together in accordance with the intended purpose of each medical device and the approved indications of each medicine, biological and other therapeutic goods; and
 (c) the contents of which are compatible, having regard to the intended purpose of each medical device, the approved indications of each medicine, biological or other therapeutic goods, and the intended purpose of the system or procedure pack.
 (4) If a system or procedure pack is intended by the manufacturer to be supplied in a sterile state:
 (a) the full quality assurance procedures (other than clause 1.6); or
 (b) the production quality assurance procedures (other than clause 4.7);
must also be applied to the system or procedure pack in relation to the aspects of the manufacturing process that relate to ensuring that the system or procedure pack is supplied and maintained in a sterile state.
Note: If a medicine is included in the system or procedure pack, the manufacturer of the system or procedure pack must ensure that the method to be used for sterilisation or resterilisation is appropriate or is in accordance with the approved indications of the medicine.

3.11  Medical devices to which the clinical