ABSTRACT
A definition of medical device according to Council Directive 93/42/ EEC of 14 June 1993 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 for human beings for the purpose of ∑ diagnosis, prevention, monitoring, treatment or alleviation of
disease; ∑ diagnosis, monitoring, treatment, alleviation or compensation
for any injury or handicap; ∑ investigation, replacement or modification of the anatomy or
of a physiological process; and ∑ control of conception, and which does not achieve its principal
intended action by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means”.
