EU IVDR Class C In Vitro Diagnostic Devices

View 3230 EU IVDR Class C In Vitro Diagnostic Devices on BEUDAMED, the Better Database on Medical Devices. Class C IVDR devices include assays and instruments with moderate-to-high public health risk, such as bloodstream infection tests and companion diagnostics. These devices require robust performance data and clinical evidence to demonstrate safety and effectiveness before being placed on the EU market.

Under the IVDR, Class C devices typically require notified body conformity assessment, comprehensive technical documentation, and ongoing post-market surveillance. Manufacturers must maintain performance evaluation reports, implement UDI and vigilance reporting, and update clinical evidence as new data emerge. BEUDAMED listings help stakeholders locate manufacturer, conformity, and regulatory status information to support compliance and procurement decisions.