Revitive Aerosure is classified as a Class I respiratory device

General medical devices (that fall within the scope of the Medical Devices Directive) are categorised into classes according to the degree of risk inherent in the device

General medical devices are grouped into four classes as follows:

  • Class I - generally regarded as low risk
  • Class IIa - generally regarded as low-medium risk
  • Class IIb - generally regarded as medium-high risk
  • Class III - generally regarded as high risk

Conformity assessment with the Therapeutic Goods Administration (TGA) requires the manufacturer to demonstrate that :

Claims made in relation to the device's safety and performance - under its normal conditions of use - are achieved