Definition
A ‘medical device’ is any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related material:
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 or of a physiological process,
- support 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;
and
b) which does not achieve its primary intended action in or on the human body by pharmaceutical, immunological or metabolic means, but which may be assisted in its intended function by such means.
