What is a medical device?

'Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: 

a) Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
◊ diagnosis, prevention, monitoring, treatment or alleviation of disease
◊ diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury
◊ investigation, replacement, modification, or support of the anatomy of a physiological process
◊ supporting or sustaining life 
◊ control of conception
◊ disinfection of medical devices
◊ providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body
◊ aids for disabled/handicapped people
◊ Prescription eye glasses and contact lenses and lens solutions
 

b) which does not achieve its primary intended action in or on the human body by pharmacologic, immunologic or metabolic means but which may be assisted in its intended function by such means.