EU IVDR Software Devices

View 143 EU IVDR Software Devices on BEUDAMED, the Better Database on Medical Devices. EU IVDR software devices include applications and algorithms intended to analyze samples, interpret diagnostic data, or support clinical decision-making for in vitro diagnostics. These products are subject to IVDR risk classification and must meet performance and safety requirements before placement on the EU market. Use the database to compare statuses, manufacturers, and conformity assessment outcomes.

IVDR classifies software for in vitro diagnostics by intended use and impact on clinical decisions, which can place software into higher risk classes requiring notified body assessment. Manufacturers must provide technical documentation, analytical and clinical performance evidence, and implement post-market surveillance and UDI labeling under the IVDR. BEUDAMED listings help stakeholders verify registration details and conformity certificates to support procurement and regulatory review. Search results assist manufacturers, labs, and regulators in tracking compliance and market access for diagnostic software.