EU IVDR Reagent Devices

View 5911 EU IVDR Reagent Devices on BEUDAMED, the Better Database on Medical Devices. Reagent devices under the EU IVDR include chemical or biological substances used alone or in combination to detect, measure or analyse samples in vitro for diagnostic purposes. These reagents are governed by IVDR requirements for performance evaluation, technical documentation and conformity assessment according to their assigned risk class.

Searchable entries provide manufacturer details, intended purpose, risk class and conformity status to help compare products efficiently. Regulatory updates, post-market surveillance obligations and summarized performance data in BEUDAMED support laboratories, clinicians and procurement teams in choosing compliant reagents. Accurate device information helps maintain regulatory compliance and patient safety across diagnostic workflows.