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Journal of Future Medicine and Healthcare Innovation(JFMHI)

Clinical Investigation

Clinical investigation of a device means the systematic study of an investigational medical device in or on human participants to assess its safety, performance or effectiveness. As per the Medical Device Rules of 2017 (MDR 2017), medical devices are categorized into four categories, depending upon the indications for use and risk level of the device. Medical devices are classified as low risk - Class A; low moderate risk- Class B; moderate high risk- Class C and high risk- Class D.