Document ID: chunk:federal_register_of_legislation:F2025C00021:reg:2:p6
Version: federal_register_of_legislation:F2025C00021
Segment Type: reg
Provision Reference: reg 2 (pt 6/40)
Character Range: 50601–53238

the device the conformity assessment procedures that must be applied to a medical device that is classified at a higher level—see subregulation 3.4(3).

3.9A  Class 1 IVD medical devices (other than devices to be used for a special purpose)
  The minimum conformity assessment procedures that must be applied to a Class 1 IVD medical device, other than a device to be used for a special purpose, are the declaration of conformity (not requiring assessment by Secretary) procedures.
Note: The manufacturer of a Class 1 IVD medical device may prefer to apply to the device the conformity assessment procedures that must be applied to an IVD medical device that is classified at a higher level—see subregulation 3.4(3).

3.9B  Class 1 in‑house IVD medical devices
  The conformity assessment procedures that must be applied to a Class 1 in‑house IVD medical device are the procedures mentioned in Part 6A of Schedule 3.

3.10  Medical devices used for a special purpose
 (1) This regulation applies to the following kinds of medical devices (medical devices used for a special purpose):
 (a) an exempt device;
 (b) a medical device that is the subject of an approval under section 41HB of the Act;
 (c) a medical device that is the subject of an authority under section 41HC of the Act;
 (d) a system or procedure pack to which subregulation (3) applies.
Note 1: An exempt device is a medical device of a kind that is exempted from the operation of Division 3 of Part 4‑11 of the Act by the regulations (see subsection 3(1) of the Act). Division 7.1 and Schedule 4 to these Regulations deal with exempt devices.
Note 2: For a system or procedure pack to which paragraph (1)(d) applies and that contains an IVD medical device and a medical device that is not an IVD medical device:
(a) the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and
(b) the conformity assessment procedures that must be applied to the system or procedure pack are the procedures for medical devices used for a special purpose in clause 7.5 of Schedule 3.
Note 3: For a system or procedure pack to which paragraph (1)(d) does not apply:
(a) the system or procedure pack is classified in accordance with Division 3.1 and either Schedule 2 or Schedule 2A; and
(b) the conformity assessment procedures that must be applied to the system or procedure pack are the procedures 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.