EU MDR Measuring Function Medical Devices

View 1571 EU MDR Measuring Function Medical Devices on BEUDAMED, the Better Database on Medical Devices. Measuring function devices provide quantitative outputs or monitor physiological and environmental parameters that inform clinical decisions and device operation. Under the EU MDR, these devices must meet applicable general safety and performance requirements and be supported by technical documentation demonstrating accuracy, reliability and intended use. Manufacturers should prepare conformity assessment evidence proportionate to risk, including performance testing and risk management.

Examples of measuring function devices include blood glucose meters, spirometers, pressure transducers and integrated sensor modules used in diagnostic and therapeutic systems. Accurate calibration, metrological traceability, clear labeling of measurement units and limits, and ongoing post-market surveillance are key regulatory and quality requirements for these products. BEUDAMED listings help stakeholders locate device registrations, notified body involvement and key conformity details to support regulatory review and procurement.