Class I, II, III devices

Medical devices are classified into three categories based on risk. Class I devices pose the lowest risk (e.g., bandages, gloves) and require basic safety controls. Class II devices present moderate risk (e.g., blood glucose monitors, infusion pumps) and need more regulatory controls to ensure safety and effectiveness. Class III devices carry the highest risk (e.g., pacemakers, heart valves) and require the most rigorous evaluation, including premarket approval, because they support or sustain life or present significant health risks. This classification helps ensure appropriate oversight tailored to each device’s potential impact on patient health.