In general terms, medical device is any physical entity, including apparatus, hardware, software, physical device or material, which supports humans to deal with medical circumstances. World health organization has given a broad definition focusing on its purpose: ‘Medical device’ means any instrument, apparatus, machine or appliance for in vitro use, hardware, software, material or other related article or the combination of it used for the specific medical purposes including diagnosis, monitoring, prevention, treatment or alleviation of disease or an injury,investigation, modification, replacement, or support for a physiological process,supporting or sustaining life,disinfection of medical devices Providing information by means of in vitro examination derived from the human body.
A device is an instrument, machine, implant, in vitro reagent, or other similar article that: is intended for use in the diagnosis, treatment, or prevention of disease – and – does not achieve its primary intended purpose through chemical action in the body or by being metabolized.
