A medical device is any instrument, apparatus, appliance
material or other article, whether used alone or in combination, including
the software necessary for its proper application intended by the manufacturer
to be used on human beings for the purpose of:
• Diagnosis, prevention, monitoring, treatment or
alleviation of diseases
• Diagnosis, prevention, monitoring, treatment or alleviation of or
compensation for an injury or handicap
• Investigation, replacement or modification of the anatomy or of a
physiological process control of conception
And which does not achieve its principal intended action in
or on the human body by pharmacological, immunological or metabolic means
but which may be assisted in its function by such means.
Source: European Union Medical Device Definition.