Revitive is classified as a Class II device. General medical devices (that fall within the scope of the Medical Devices Directive) are categorized into classes according to the degree of risk inherent in the device General medical devices are grouped into four classes as follows:
Class I lowest risk
Class II Medium Risk
Class III Medium/High Risk
Class IV Greatest 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.