vitalera’s finishes the MDR Class IIa certification milestone

DHH member vitalera has achieved a significant milestone by successfully finishing the first phase of the rigorous reclassification process to MDR Class IIa. This achievement was backed by outstanding clinical trial results and supervised by Ente Certificazione Macchine Srl, a notified body (No. 1282) for the new European Medical Devices Regulation (MDR), designated by Italy's Ministry of Health, with the notification published on the European Commission’s NANDO portal on October 14, 2022.

This milestone marks the culmination of over two years of dedicated work, involving collaboration with more than seven hospitals and positioning vitalera as an interoperable medical remote patient platform capable of managing any disease, regardless of the clinical condition.

The clinical trials focused on monitoring patients with chronic diseases, demonstrating the transformative potential of vitalera's platform. The VAL-HIC clinical study, led by the Hospital Clínic de Barcelona, revealed that telemonitoring with the vitalera platform is as effective as standard care in improving quality of life and promoting self-care among patients with heart failure (HF). The platform empowers patients, enhances clinical outcomes, and supports healthcare professionals by streamlining care delivery. It also alleviates the burden on doctors and caregivers by automating the detection of anomalies in patient data, accelerating decision-making, and reducing hospital visits.

Through this study, vitalera validated the platform effectiveness for patients and the digital platform’s value for medical professionals by measuring improvements in patients’ quality of life and reductions in critical health events.

This achievement positions vitalera’s solution to secure Class IIa certification (Medical Device Regulation) in the near future, further solidifying its reputation as a reliable and compliant healthcare innovation.

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