MDC: Invasive? (10)
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Decision tree
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Is your device invasive or non-invasive?
Body
Non-invasive devices
May come into contact with a patient or they may not, but they do not penetrate the body of a patient.
This means they do not enter any body orifices such as the mouth or nostrils; they do not touch the eyes; and even though they may come into contact with injured skin, they do not pierce the skin in any way.
Invasive medical device
Is intended by the manufacturer to be used, in whole or in part, inside the body of a human being.
This includes devices that enter a body orifice or that penetrate the surface of the body, or that enter the body in the context of a surgical operation.
A medical device that touches the surface of the eye, such as a contact lens, is in a body orifice.
Question
Based on the above definition, what type of device do you think you have?
Answers