A medical apparatus is an instrument, device, appliance, in vitro diagnostic reagents and calibrators, materials, and other similar or related items used directly or indirectly in the human body, including computer software required. Its utility is obtained primarily by physical means, rather than by pharmacological, immunological or metabolic means, or although these means are involved but only play an auxiliary role. The purpose of a medical apparatus is the diagnosis, prevention, monitoring, treatment or mitigation of diseases, the diagnosis, monitoring, treatment, mitigation or functional compensation of injuries, the examination, replacement, regulation or support of physiological structures or processes, ...