Medical devices are instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items used directly or indirectly in the human body, including the required computer software; their utility is mainly obtained by physical means, not by pharmacological, immunological or metabolic means, or although these means are involved but only plays a supplementary role; their purpose is the diagnosis, prevention, monitoring, treatment of disease, monitoring, therapy, and so on. purpose is the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; the examination, substitution, regulation, or support of physiological structures or processes; the support or maintenance of life; the control of pregnancy; and the provision of information for medical or diagnostic purposes through the examination of specimens from the human body.