Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p8
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 8/11)
Character Range: 329244–331869

in the case where the absence of the treatment or intervention or where the treatment or intervention itself:
 (i) may otherwise be harmful to a person; or
 (ii) may pose a moderate risk to public health;
  is classified as Class IIb; or
 (c) in any other case—is classified as Class IIa.
 (2) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to recommend a treatment or intervention (the recommended treatment or intervention) to a relevant health professional for the purposes of the health professional making a decision about the treatment or intervention:
 (a) in the case where the absence of the recommended treatment or intervention or where the recommended treatment or intervention itself:
 (i) may lead to the death of a person or a severe deterioration in the state of a person's health; or
 (ii) may pose a high risk to public health;
  is classified as Class IIb; or
 (b) in the case where the absence of the recommended treatment or intervention or where the recommended treatment or intervention itself:
 (i) may otherwise be harmful to a person; or
 (ii) may pose a moderate risk to public health;
  is classified as Class IIa; or
 (c) in any other case—is classified as Class I.

4.8  Programmed or programmable medical device or software that is a medical device that is to provide therapy to a person through the provision of information
  A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to provide therapy to a person through the provision of information to the person:
 (a) in the case of therapy that may result in the death of the person or a severe deterioration in the state of the person's health—is classified as Class III; or
 (b) in the case of therapy that may cause serious harm to the person and where paragraph (a) does not apply—is classified as Class IIb; or
 (c) in the case of therapy that may cause harm to the person and where neither paragraph (a) nor (b) applies—is classified as Class IIa; or
 (d) in any other case—is classified as Class I.

Part 5—Special rules for particular kinds of medical devices

5.1  Medical devices incorporating a medicine
 (1) This clause applies to a medical device of any kind that incorporates, or is intended to incorporate, as an integral part, a substance that:
 (a) if used separately, would be a medicine; and
 (b) is liable to act on a patient's body with action ancillary to that of the device.
 (2) The device is classified as Class III.
 (3) For the purposes of this clause, any stable