MDC: HPO. Disease? (45)

Is the device intended to:

1. Provide information to a relevant health professional for them to make a diagnosis of a disease or condition that is:
   1. a serious disease or serious condition, or 
   2. a disease or condition that may pose a moderate 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 danger (but not immediate danger), or
   2. that there may be a moderate risk to public health
3. Recommend a treatment or intervention, where the treatment or intervention, or its absence, may:
   1. be harmful to a person (but not lead to their death or a severe deterioration in their state of a health), or
   2. pose a moderate risk to public health
4. Provide information as therapy to a person that may cause harm to the person (not serious harm, 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 energy is non-hazardous)
6. Supply energy that will be absorbed by a patient’s body (other than a device that is intended only to illuminate the patient’s body in the visible spectrum)
7. Image in vivo distribution of radiopharmaceuticals in a patient
8. Used to allow direct diagnosis or monitoring of vital physiological processes of a patient (other than those that could result in immediate danger to the patient)
9. Used to administer or remove medicine, body liquids or other substances (that are non-hazardous) to or from a patient.