An in-vitro diagnostic is a product used for disease diagnosis, treatment, or prevention in humans or animals. According to the Medical Devices Rules, 2017, in-vitro diagnostics are classified into four classes based on their risk: Class A, Class B, Class C, and Class D. Class A and Class B in-vitro diagnostics are considered low-to-moderate risk. Class A in-vitro diagnostics are low-risk devices that require little to no invasiveness (like specimen receptacles, laboratory instruments) In-vitro diagnostics in Class B are low-to-moderate risk devices with minimal invasiveness (like fertility tests, and cholesterol tests). In-Vitro Diagnostic IVD Class A B Manufacturing License/ Registration - Class A B IVD Regulatory Services. Regulatory Compliance and Licensing Services For IVD Class A & B by CliniExperts. Call +91 7672005050