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@article{194918,
        author = {Siddhi pashte and Ainul Shafeeque and Devyani Patil and Dr.Ganesh Ahire},
        title = {An Overview of Materiovigillence in Medical Device Safety: Regulatory Framework, challenges, and Future Direction},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {10},
        pages = {5824-5831},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=194918},
        abstract = {Materiovigilance focuses on the systematic monitoring of medical devices associated with adverse events, referred to as medical device adverse events (MDAEs). Materiovigilance and pharmacovigilance share a common objective and methodological approach aimed at ensuring patient safety. Through continuous evaluation of safety data, materiovigilance plays a vital role in identifying and facilitating the recall of defective or malfunctioning medical devices. All MDAEs, whether known or unknown, critical or non-critical, frequent or infrequent, or resulting from inadequate or missing specifications must be reported and thoroughly assessed. Materiovigilance contributes to the prevention of device-related complications and failures while enhancing the safety, performance, and design of medical equipment. It also serves to alert healthcare professionals and users to counterfeit or substandard devices. Commonly reported adverse events include device malfunction or breakage, infections at insertion or exit sites, organ damage or perforation, the need for surgical intervention, life cycle related device issues, and, in severe cases, death. Regulatory authorities worldwide have established structured and time-bound reporting systems for MDAEs, such as CDSCO in India Medsafe in New Zealand and MedWatch in the United States. Emphasizing the role of materiovigilance is essential to ensure the safe use of medical devices and to educate healthcare professionals and consumers about reporting mechanisms and appropriate response strategies following device related adverse events.},
        keywords = {Materiovigillence, Medical device adverse Event, Patient safety, Post Marketing surveillance.},
        month = {March},
        }