EU IVDR Instrument Devices

View 2088 EU IVDR Instrument Devices on BEUDAMED, the Better Database on Medical Devices. Instrument devices under the EU In Vitro Diagnostic Regulation include laboratory analyzers, sample preparation systems and other tools used to perform in vitro diagnostic testing. These instruments must meet IVDR requirements for performance, risk classification and complete technical documentation before being placed on the EU market.

Manufacturers of IVDR instrument devices must demonstrate conformity through appropriate classification, clinical and performance evidence where applicable, and maintain post-market surveillance. Higher-risk instruments commonly require notified body involvement and ongoing vigilance to comply with reporting and safety obligations under the IVDR.