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Country	Classification Levels	Risk Factors
United States	Medical Devices - Class I: Low risk (e.g., bandages, tongue depressors) - Class II: Moderate risk (e.g., blood pressure monitors, infusion pumps) - Class III: High risk (e.g., pacemakers, stents) IVD (In Vitro Diagnostic) - Class I: Low risk (e.g., general lab reagents) - Class II: Moderate risk (e.g., blood glucose meters) - Class III: High risk (e.g., HIV diagnostics)	Medical devices are classified based on patient risk, with Class I being the lowest and Class III being the highest. IVDs are regulated similarly, with risk levels depending on the public health impact and diagnostic purpose.
Europe (MDR & IVDR)	Medical Devices (MDR) - Class I: Low risk (e.g., non-invasive devices like bandages) - Class IIa: Low to moderate risk (e.g., hearing aids, dental fillings) - Class IIb: Moderate to high risk (e.g., infusion pumps) - Class III: High risk (e.g., implants, pacemakers)	Medical devices are classified by invasiveness, duration, and risk, with Class I being the lowest risk and Class III the highest. IVDs are regulated under the IVDR with a four-class system, ranging from low risk (Class A) to high risk (Class D).
	IVD (IVDR) - Class A: Low risk (e.g., sample containers) - Class B: Moderate risk (e.g., pregnancy tests) - Class C: Higher risk (e.g., blood glucose monitoring) - Class D: Highest risk (e.g., HIV tests, blood screening)

Country	Classification Levels	Risk Factors
United States	Medical Devices - Class I: Low risk (e.g., bandages, tongue depressors) - Class II: Moderate risk (e.g., blood pressure monitors, infusion pumps) - Class III: High risk (e.g., pacemakers, stents) IVD (In Vitro Diagnostic) - Class I: Low risk (e.g., general lab reagents) - Class II: Moderate risk (e.g., blood glucose meters) - Class III: High risk (e.g., HIV diagnostics)	Medical devices are classified based on patient risk, with Class I being the lowest and Class III being the highest. IVDs are regulated similarly, with risk levels depending on the public health impact and diagnostic purpose.
Europe (MDR & IVDR)	Medical Devices (MDR) - Class I: Low risk (e.g., non-invasive devices like bandages) - Class IIa: Low to moderate risk (e.g., hearing aids, dental fillings) - Class IIb: Moderate to high risk (e.g., infusion pumps) - Class III: High risk (e.g., implants, pacemakers)	Medical devices are classified by invasiveness, duration, and risk, with Class I being the lowest risk and Class III the highest. IVDs are regulated under the IVDR with a four-class system, ranging from low risk (Class A) to high risk (Class D).
	IVD (IVDR) - Class A: Low risk (e.g., sample containers) - Class B: Moderate risk (e.g., pregnancy tests) - Class C: Higher risk (e.g., blood glucose monitoring) - Class D: Highest risk (e.g., HIV tests, blood screening)