What is a medical device and what are the different classes of Medical Devices?
A medical device can be defined as any device that is used by human beings to diagnose and cure a disease or illness in the human body. Also, a medical device can be termed as anything that is created or adopted by a human for a medical purpose only. According to EU MDR, ‘medical device’means any instrument, apparatus, appliance, software, implant, reagent, material, or any other article intended by the manufacturer to be used, alone or in combination, by human beings for one or more of the following medical purposes – Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease. Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury, or disability. Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state. Providing information by means of an in-vitro examination of specimens derived from the human body, including organ, blood, or tissue donation, and which does not a