ABSTRACT
A medical device is an instrument, apparatus, appliance, material, or other article, whether used alone or in combination, together with any software necessary for its proper application, which
a. is intended by the manufacturer to be used for human beings for the purpose of i. diagnosis, monitoring, treatment, alleviation of disease, ii. diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap, iii. investigation, replacement, or modification of the anatomy or of a physiological
process, or iv. control of conception, and
b. does not achieve its principal intended action in or on the human body by pharmacological, immunological, or metabolic means, even if it is assisted in its function by such means (1).
