Digital health company Ada Health has announced 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).
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Concept of MDR Medical Device Regulation.
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 integrate Ada’s symptom assessment, care navigation and clinical handover capabilities into an enterprise partner’s digital channels, such as websites, apps and user portals.
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 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, a 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.
Although EU-MDR is only applicable in Europe, Ada’s quality management system, as certified by TÜV SÜD, is also compliant with ISO 13485, a global standard to ensure quality and safety.
Claire Novorol, co-founder and chief medical officer at Ada Health said: “The EU-MDR is one of the world’s most robust health tech regulations and it has a vital role to play in ensuring medical devices meet the highest standards as well as giving confidence to healthcare systems and partners that want to innovate with digital technologies for their patients. Our EU-MDR certification is a reflection of Ada’s commitment to safety and medical quality. We’ve always welcomed the development of robust international standards and are delighted to be a leader in our space as one of the first digital health companies to secure EU-MDR certification.”
Ada has already proven itself as the world’s most popular health assessment tool and has empowered over 12 million users globally to make better-informed health decisions through its consumer app, and over 50 million more have access to Ada through its enterprise partnerships.
