EU IVDR Class B Software Devices

View 4 EU IVDR Class B Software Devices on BEUDAMED, the Better Database on Medical Devices. Class B IVD software is considered a moderate-risk category under the IVDR and often supports diagnostic workflows or clinical decision-making. These devices commonly require conformity assessment with a notified body and documented evidence of performance and risk management.

Manufacturers of Class B software must prepare robust technical documentation, performance evaluation, and a quality management system aligned with IVDR requirements. Software-specific expectations include algorithm validation, version control, cybersecurity measures, and ongoing post-market surveillance to detect changes in real-world performance. Relevant devices are also subject to UDI assignment and EUDAMED registration when the applicable modules are available.