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DEFINITIONS


 

 

 

Medical Device Europe

 


 

 

 

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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