The classification of an IVD is also regulated in the IVDR within the framework of risk-based classification. As in the Medical Device Regulation (MDR), the classification is based on the intended purpose of the product and the resulting risk profile. According to the IVDR, the classification is made into classes A, B, C and D.
The IVDR defines the risk class of a product on the basis of seven rules. If there is a low risk, products are assigned to class A. As the risk increases, products are assigned to classes B, C or D. Only for medical devices in class A is it possible for manufacturers to declare conformity themselves for market placement; for the other risk classes, the notified bodies must be involved in the conformity assessment procedure.