Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:2:p6
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 2 (pt 6/11)
Character Range: 324499–327154

is classified as Class I—see clause 4.1 of this Schedule.
 (3) If:
 (a) the device is intended by the manufacturer specifically to be used to monitor vital physiological parameters of a patient, and the nature of the variations monitored is of a kind that could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system); or
 (b) the device is intended by the manufacturer to emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology; or
 (c) the device is intended by the manufacturer to be used to control or monitor, or directly influence, the performance of a device of the kind mentioned in paragraph (b);
the device is classified as Class IIb.

4.4  Active medical devices intended to administer or remove medicines, etc from a patient's body
 (1) Subject to subclause (2), an active medical device that is intended by the manufacturer to be used to administer medicine, body liquids or other substances to a patient, or to remove medicine, body liquids or other substances from a patient, is classified as Class IIa.
 (2) If the device is of a kind such that the administration or removal of the medicine, body liquids or other substances is potentially hazardous to the patient, having regard to the nature of the substances involved, the part of the patient's body concerned, and the characteristics of the device, the device is classified as Class IIb.

4.5  Programmed or programmable medical device or software that is a medical device for use in relation to diagnosing or screening for a disease or condition
 (1) A programmed or programmable medical device, or software that is a medical device, that is intended by the manufacturer to be used to:
 (a) provide a diagnosis of a disease or condition; or
 (b) screen for a disease or condition;
is classified as:
 (c) 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;
  Class III; or
 (d) 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 (c) does not apply—Class IIb; or
 (e) in any other case—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 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