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Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related articles that are directly or indirectly used in the human body, including required computer software.
Medical devices include medical equipment and medical consumables.
Utility is obtained mainly by physical means, not by pharmacological, immunological or metabolic means, or although these means are involved but only auxiliary.
The 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 physiological processes; the support or maintenance of life; the control of pregnancy; the provision of information for medical or diagnostic purposes through the examination of samples from the human body.
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