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 medium risk
- Class IIb - generally regarded as medium risk
- Class III - generally regarded as high risk
Conformity assessment with the European Directive 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.