Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p7
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 7/11)
Character Range: 326922–329473

is a medical device, that is intended by the manufacturer to be used to provide information to a relevant health professional for the purposes of the health professional making a diagnosis of a disease or condition:
 (a) in the case of a disease or condition that:
 (i) may lead to the death of a person, or a severe deterioration in the state of a person's health, without urgent treatment; or
 (ii) may pose a high risk to public health;
  is classified as Class IIb; or
 (b) in the case of a serious disease or serious condition or a disease or condition that may pose a moderate risk to public health, and where paragraph (a) does not apply—is classified as Class IIa; or
 (c) in any other case—is classified as Class I.

 4.6  Programmed or programmable medical device or software that is a medical device for use for monitoring the state or progression of a disease or condition etc.
  A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to provide information that is to be used for monitoring the state or progression of a disease or condition of a person or the parameters in relation to a person:
 (a) in the case where the information to be provided could indicate that the person or another person may be in immediate danger or that there may be a high risk to public health—is classified as Class IIb; or
 (b) in the case where the information to be provided could indicate that the person or another person may be in other danger or that there may be a moderate risk to public health—is classified as Class IIa; or
 (c) in any other case—is classified as Class I.

4.7  Programmed or programmable medical device or software that is a medical device for use in specifying or recommending treatment or intervention
 (1) Subject to subclause (2), a programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to specify or recommend a treatment or intervention:
 (a) in the case where the absence of the treatment or intervention or where the 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 III; or
 (b) 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