Medical device class (MDC) is a category that defines the amount of risk involved with a medical device in the United Statesand the proper procedures that must be followed when manufacturing and using the device.
Medical devices are separated into three categories: Class I, Class II and class III.
Class I Medical Devices have simple design and pose little to no potential risk of injury or illness. Examples of devices in this category include elastic bandages, examination gloves and tongue depressors. Class II medical devices have a more complex design and pose minimal risk of injury or illness. Examples of devices in this category include wheel chairs, X-ray machines, infusion pumps and surgical needles. Class III devices have intricate design and support or sustain human lives, therefore devices in this category pose great risk of injury or illness. Examples of devices in this category include heart valves, implanted pacemakers and cerebral simulators.
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