Emerging Horizons in Materiovigilance: Global Innovations and Regulatory Advances
Year: 2025
Type: article
Abstract: Materiovigilance, the science and activities relating to the detection, assessment, understanding, and prevention of adverse events associated with medical devices, has undergone rapid evolution in recent years. Global and national regulatory authorities, including the Materiovigilance Programme of India (MvPI), have introduced significant reforms to strengthen post-market surveillance. Recent updates include the mandatory establishment of Medical Device Adverse Event Committees (MDAECs) in healthcare institutions, revised reporting forms by the Central Drugs Standard Control Organization (CDSCO), and alignment of device standards with the National Medical Device Policy 2023. Alongside these policy changes, there has been a surge in capacity‑building initiatives, such as regional training programmes, awareness workshops, and the inclusion of materiovigilance concepts in professional development curricula. Technological advancements—particularly in artificial intelligence, machine learning, Bayesian signal detection, blockchain, wearable devices, and automated label‑extraction tools—are enhancing data accuracy, traceability, and predictive safety monitoring. However, challenges such as under‑reporting, limited awareness, fragmented data systems, and ethical considerations in AI integration persist. Knowledge, attitudes, and practice (KAP) surveys among healthcare professionals reveal moderate awareness but low reporting rates, highlighting the urgent need for structured training and mandatory reporting mechanisms. This review consolidates recent regulatory, technological, and educational advancements in materiovigilance, critically examines existing barriers, and outlines future directions for building robust, integrated, and proactive device safety monitoring systems. These developments collectively indicate a paradigm shift toward patient‑centric and technology‑enabled materiovigilance, promising enhanced medical device safety and improved healthcare outcomes.
Author: Swarup Sanjeev Nandargi*1, Balaji Kakaso Jadhav2, Gaurav Sachin Makte3, Vijay Vithoba Shinde4, Dipak Babaso Bhingardeve5
Language: English
Subfield: Toxicology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W7078335860
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