Any instrument, apparatus, appliance, material or other, article, whether used alone or in combination, together with any accessories including the software necessary for its proper application and functioning, 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 or alleviation of compensation for any injury or handicap- Investigation, replacement or modification of the anatomy or of a physiological process- Control of conception. AS Active medical device- -Active implantable medical device -Custom-made device -Device intended for clinical investigation -Device for self-testing And which dose not achieve its principal intended action in or on the human body by:- -Pharmacological -Immunological -etabolic means. But which may be assisted in its function by such means.