Strengthening Medical Device Safety through Regulations and Materiovigilance

Nancy Mittal; Agrim Prakash; Puneet; Puneet Dhamija

doi:10.36948/ijfmr.2026.v08i02.70019

Strengthening Medical Device Safety through Regulations and Materiovigilance

Author(s)	Dr. Nancy Mittal, Dr. Agrim Prakash, Dr. Puneet, Dr. Puneet Dhamija
Country	India
Abstract	Materiovigilance is essential in contemporary healthcare, safeguarding the safety and efficacy of medical devices post-market release. While sometimes eclipsed by pharmacovigilance, materiovigilance is dedicated to the identification, analysis, and prevention of device-related adverse events by systematic data collection and assessment. The primary objective is to safeguard patients by early identification of dangers and ensuring the effective and safe operation of medical devices in practical environments. This study aims to emphasize the fundamental elements of materiovigilance and draw attention to the considerable lack of awareness regarding this crucial yet underappreciated facet of healthcare. A thorough literature search was performed utilizing databases such as PubMed, Embase, Scopus, and Cochrane, employing keywords like “materiovigilance,” “pharmacovigilance,” “materiovigilance history,” and “awareness of materiovigilance.” Relevant papers were analyzed to discern patterns, deficiencies, and fundamental issues. The findings demonstrate that essential components, including comprehensive reporting systems, systematic risk assessment, and stringent regulatory control, are fundamental to guaranteeing medical device safety. Notwithstanding these established systems, a significant lack of knowledge endures among healthcare personnel and stakeholders, heightening the risk of underreporting and jeopardizing patient safety. This analysis underscores the necessity of addressing this deficiency by education, training, and coordinated participation in materiovigilance activities. Enhancing knowledge and promoting active engagement among regulatory authorities, healthcare practitioners, and manufacturers can substantially improve materiovigilance procedures. Collaborative initiatives will enhance the safety of healthcare environments and guarantee the efficient and dependable utilization of medical equipment globally.
Keywords	Materiovigilance, Medical device safety, Adverse event reporting, Risk assessment, Regulatory oversight, Patient safety
Field	Medical / Pharmacy
Published In	Volume 8, Issue 2, March-April 2026
Published On	2026-03-13
DOI	https://doi.org/10.36948/ijfmr.2026.v08i02.70019

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Strengthening Medical Device Safety through Regulations and Materiovigilance

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