MDC: HPO. Death? (42)

Is the device intended to do any of the following?

1. Provide information to a relevant health professional for them to make a diagnosis of a disease or condition that may:
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health without urgent treatment, or
   3. pose a high risk to public health
2. Provide information that is to be used for monitoring the state or progression of a disease or condition, or parameters that could indicate that:
   1. the person or another person may be in immediate danger, or
   2. there may be a high risk to public health.
3. Recommend a treatment or intervention, where the treatment or intervention, or its absence, may:
   1. lead to the death of a person, or
   2. lead to a severe deterioration in the state of a person’s health, or
   3. pose a high risk to public health.
4. Provide information as therapy to a person that may cause serious harm to the person (not death or a severe deterioration in the state of the person’s health)
5. Administer or exchange energy to or from a patient, where the administration or transfer of energy occurs in a potentially hazardous way, or used to control, monitor, or directly influence, the performance of a medical device that does this
6. Monitor vital physiological parameters of a patient, where the nature of the variations monitored could result in immediate danger to the patient (for example, variations in cardiac performance, respiration, activity of the central nervous system
7. Emit ionising radiation and to be used for diagnostic or therapeutic interventional radiology or used to control or monitor, or directly influence, the performance of a device that does this
8. Used to administer or remove medicine, body liquids or other substances to or from a patient, where the administration or removal of the substances is potentially hazardous to the patient.