EU IVDR Class A In Vitro Diagnostic Devices

View 10000 EU IVDR Class A In Vitro Diagnostic Devices on BEUDAMED, the Better Database on Medical Devices. Class A IVDs are the lowest-risk category under the IVDR, generally covering products used in laboratory settings that pose minimal individual and public health risk. These devices typically do not require notified body involvement for conformity assessment unless they are supplied sterile, but manufacturers must still meet IVDR obligations.

Manufacturers of Class A IVDs must prepare proportionate technical documentation, carry out risk management and performance evaluation, and maintain evidence that the device meets applicable requirements. Labelling, UDI assignment, post-market surveillance and vigilance reporting are required to ensure ongoing safety and compliance for these low-risk diagnostic devices.