EU IVDR Class D Software Devices

View 0 EU IVDR Class D Software Devices on BEUDAMED, the Better Database on Medical Devices. Class D devices under the IVDR represent the highest risk category for in vitro diagnostics and include software that influences critical diagnostic or public health decisions. These products require notified body assessment and comprehensive conformity procedures before they can be placed on the EU market.

Manufacturers must supply robust analytical and clinical performance data, a complete technical documentation package, and a compliant quality management system for Class D software. Post-market surveillance, vigilance reporting, and periodic performance evaluations are essential given the potential patient safety and public health impact of these high-risk IVD software devices.