A medical device is an instrument, apparatus, implant, software or related article used to diagnose, prevent, or treat disease or other conditions. It must not achieve its primary intended action in or on the human body through pharmacological, immunological or metabolic means, but may be assisted in its function by such means.
Medical devices vary greatly in complexity and application. They are intended by the manufacturer to be used for:
Diagnosis, prevention, monitoring, treatment, or alleviation of disease.
Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or handicap.
Investigation, replacement, or modification of the anatomy or of a physiological process.
