Ada Health Receives EU-MDR Certification for AI-Powered Symptom Assessment Platform

Ada Health GmbH the global digital health company focused on improving human health at scale, announces that Ada Assess has successfully been certified as a Class IIa medical device under the European Union Medical Device Regulation (Regulation (EU) 2017/745) (EU-MDR). As an independent validation of Ada’s commitment to the highest standards of efficacy and safety, the certification is a major milestone for the business and reinforces Ada Health’s position as a leader within the AI-based health and symptom assessment category and its commitment to medical quality.

The EU-MDR is the medical device regulation applied by the European Commission. It was established to set EU-wide rules to improve the safety and quality of medical devices and provide transparency for patients to ensure public health and patient safety.

The Ada Assess enterprise solution is among the first AI-based symptom assessment platforms to be certified as a Class IIa medical device. Ada’s enterprise solutions allow its partners to transform care pathways by integrating Ada’s symptom assessment, care navigation and clinical handover capabilities into an enterprise partner’s digital channels, such as websites, apps and user portals, helping to build digital front doors with seamless user experience.

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To secure Class IIa classification, Ada Health had to consistently demonstrate that its Ada Assess solution, and quality management system (QMS) meet the EU-MDR’s rigorous standards for safety and effectiveness. This involved undergoing external audits, submitting technical documentation, and supplying proof of clinical benefits and studies for review by TÜV SÜD Product Service GmbH, an independent third-party certification organisation (or “Notified Body”) based in Germany. The Ada Assess solution includes many of Ada’s core components including its medical content platform, symptom assessment, its care navigation and digital triage, handover for sharing assessment reports with clients, as well as interoperability services that are essential for integration with partner systems and Smart Authorisation controls for identity management and secure single sign-on (SSO).

EU-MDR has replaced the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). Ada’s certification is thanks to a company-wide commitment to demonstrating that Ada meets the strict quality principles demanded by EU-MDR and a determination to continually evolve and improve its product offering to meet customers’ needs.

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