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The Medical Device Regulation (MDR) is a comprehensive set of regulations introduced by the European Union to ensure the safety, efficacy, and quality of medical devices. These regulations have replaced the previous Medical Device Directive (MDD), bringing stricter oversight, enhanced transparency, and more rigorous clinical evaluation requirements. Our AI tools, now certified by BSI as Class IIb medical devices, reflect a high level of clinical validation and compliance with the European Union’s MDR 2017/745.
For manufacturers, especially those developing AI-powered solutions, MDR compliance is not just a legal obligation but a critical component in building trust with healthcare providers and patients. It ensures that AI-driven medical devices meet the highest standards of safety and performance, which is vital in a field where precision and reliability can directly impact patient outcomes.
“Obtaining MDR certification is a significant milestone for Avicenna.AI. It demonstrates our commitment to meeting the highest standards of medical device safety and performance. This certification not only reinforces our dedication to compliance but also assures our customers of the quality and reliability of our AI product portfolio.”
— Stéphane Berger, Regulatory Manager, Avicenna.Ai
The Medical Device Regulation (MDR) has introduced several significant changes aimed at enhancing the safety, performance, and transparency of medical devices in the European Union. These changes profoundly impact all medical device manufacturers, particularly those developing AI-powered solutions. The new regulation emphasizes clinical evidence, risk management, and post-market surveillance, ensuring that AI-driven devices meet the highest standards throughout their lifecycle.
🧠 CINA-ICH: Intracranial hemorrhage
🧠 CINA-LVO: Large vessel occlusion
The Medical Device Regulation (MDR) introduces specific requirements that significantly impact AI solutions in the medical device sector. MDR emphasizes rigorous clinical validation, comprehensive documentation, and continuous performance monitoring, all of which are crucial for AI-driven healthcare solutions.
For instance, the MDR mandates that AI algorithms undergo thorough testing and validation to demonstrate their safety and efficacy across various patient populations. This includes detailed documentation of how the AI model functions and performs, as well as how it handles different clinical scenarios. The regulation also requires ongoing post-market surveillance to ensure that the AI solution remains effective and safe throughout its lifecycle.
Feel free to request our compliance documents, including our Data Privacy Policy, Certificates, and more.