Abstract
AI-eMDs IN INDIA: ADVANCING TOWARDS AN AI-READY MATERIOVIGILANCE ECOSYSTEM
Artificial Intelligence-enabled Medical Devices (AI-eMDs) areincreasingly reshaping the Indian healthcare system by enhancing diagnosticaccuracy, supporting clinical decision-making, enabling continuous patientmonitoring, and assisting personalised care. India is witnessing rapid growthin the development and adoption of these technologies, driven by a vibrantinnovation landscape, advancing digital health systems, and supportivegovernment policies.
AI-eMDs differ from conventional technologies because their performance may beinfluenced by algorithm behaviour, data quality, software updates,cybersecurity, and evolving real-world clinical environments. Thesecharacteristics broaden the scope of post-market surveillance beyondtraditional hardware-focused monitoring and necessitate additional safetyconsiderations throughout the lifecycle of the AI-eMDs.The MateriovigilanceProgramme of India (MvPI) has established a strong framework for monitoring thesafety and performance of medical devices through systematic post-marketsurveillance. This review highlights the strengths of the existing IndianMateriovigilance framework and explores how established surveillance principlescan be expanded to address the unique challenges associated withsoftware-driven and continuously evolving medical technologies. The reviewproposes the concept of an ‘AI-ready Materiovigilance ecosystem’ as anext-generation extension of conventional Materiovigilance that incorporatesstandardized AI-specific reporting, digital health integration, softwarelifecycle monitoring, and real-world evidence acquisition for AI-eMDs.
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