2 medical devices: 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; its utility is mainly obtained through physical and other means, not through pharmacology, immunology or metabolism, or although there are involved in these ways, but only plays a ancillary; the purpose of which is the diagnosis, prevention, monitoring, treatment, or mitigation of disease; the diagnosis, monitoring, treatment, mitigation, or functional compensation of injury; the examination, replacement, 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 derived from the human body.