EU IVDR Class B In Vitro Diagnostic Devices

View 3893 EU IVDR Class B In Vitro Diagnostic Devices on BEUDAMED, the Better Database on Medical Devices. EU IVDR Class B IVDs are moderate-risk diagnostic products that can include reagents, instruments, and standalone software with potential impacts on patient or public health. These devices generally require notified body involvement for conformity assessment and proportionate clinical and performance evidence.

Class B devices must meet IVDR requirements for technical documentation, analytical and clinical performance, and post-market surveillance. Manufacturers need risk management records, traceability, and vigilance processes to support market access and ongoing compliance with the regulation.