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 required computer software. Medical devices include medical equipment and medical consumables, the utility of which is obtained primarily by physical means, by pharmacological, immunological or metabolic means, or which are involved in such means but only in an ancillary manner, for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease, diagnosis, monitoring, treatment, alleviation, or compensation of function in the event of injury, examination of physiological structures or processes, replacement, regulation or support, life support, or compensation for function. regulation or support, life support or maintenance, pregnancy control, providing information for medical or diagnostic purposes through the examination of samples from the human body.