Regulatory Risk Classification: Global Frameworks
Regulators (like the FDA or EMA) classify IVDs based on the risk posed by an incorrect result.
Class I (Low Risk): Includes general laboratory equipment like specimen receptacles or basic culture media.
Class II (Moderate Risk): Includes tests for common conditions like pregnancy, cholesterol, or blood glucose.
Class III (High Personal/Public Risk): Includes tests for infectious diseases (HIV, Hepatitis), cancer markers, and genetic tests that determine life-altering treatments.
1 View