Table 1.

Examples of product classification

	Classification	Risk	Description	Examples
	General controls			Hospital beds, bed pans
I	Sterile (Is)	Low	Most non-invasive devices that do not interact with the body.	Sterile plasters
	Measuring (Im)			Thermometers, weighing scales.
IIa	Special controls required: may include special labelling, mandatory performance standards & post-market surveillance	Medium	Exchange energy with a patient in a therapeutic manner or are used to diagnose or monitor medical conditions. Generally invasive but limited to natural orifices, if hazardous to a patient then it becomes a class IIb	Powered wheelchairs, hearing aids, ultrasonic diagnostic equipment
IIb	Special controls (as IIa)	Medium	Most surgically invasive/active devices partially or totally implantable in the body. May modify composition of body fluids.	Infusion pumps, ventilators, surgical lasers
III	Pre-market approval is the required process of scientific review to ensure the safety and effectiveness of these	High	Support or sustain human life and are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Device that connects directly with the Central Circulatory System or CNS, or contains a medicinal product.	Many implants: vascular & neurological, replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators