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.
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