ABSTRACT
It is the responsibility of the manufacturer to determine the classification of its medical device as early as possible in the device development. Its determination should be based on rules derived from the potential of a medical device to cause harm to a patient or user and thereby on its intended use and the technology it utilizes. The manufacturer should first clearly define the intended use of the device. The class determination can be influenced by several factors, including the duration of device contact with the body, the degree of invasiveness, whether the device delivers medicinal products or energy to the patient. In vitro Diagnostics are medical devices intended to perform diagnoses from assays in hematology, immunology, microbiology, etc.
