Anand Shalya, Sönmez Ömer Faruk
Center for Adaptive Rationality, Max Planck Institute for Human Development, Berlin, Germany; Subject Area Dental Devices and Materials, Materiovigilance Program of India, New Delhi, India; Oral Health Literacy Division, International Health Literacy Association, St Louis, MO, USA.
School of Medicine and Population Health, University of Sheffield, Sheffield, UK.
Int Dent J. 2025 Aug 6;75(5):100943. doi: 10.1016/j.identj.2025.100943.
Dental and medical devices are fundamental to oral healthcare delivery; however, their growing utilization and increasing variety of products due to the material innovation, introduces potential risks of adverse events. Despite the existence of regulatory frameworks, adverse events are underreported and the awareness among dental professionals remains low. This review presents the first comparative analysis in the literature of international materiovigilance systems for dental devices and examines how harmonized adverse event reporting could improve their global safety, efficacy, and reliability. A narrative review was undertaken, drawing upon peer-reviewed literature and regulatory documents. Comparative analyses were performed across systems in the United States, European Union, United Kingdom, Australia, and India, to explore diversity in regulatory maturity, geographic representation, and influence on global dental device markets. Key areas of focus included regulatory classifications, mandatory reporting requirements, post-market surveillance strategies, and integration into clinical practice. Findings from international frameworks such as the European Union's Medical Device Regulation (MDR), the U.S. FDA's Medical Device Reporting system, the UK's MHRA reporting mechanisms, Australia's TGA Incident Reporting and Investigation Scheme (IRIS), and India's Materiovigilance Programme (MvPI), indicate that standardized reporting mechanisms significantly enhance adverse event detection and enable timely interventions. However, discrepancies in regulatory standards, reporting protocols, and stakeholder engagement practices continue to impede the development of a cohesive global materiovigilance framework for dental devices. Effective materiovigilance in dentistry necessitates coordinated international efforts involving regulators, manufacturers, healthcare professionals, and patients. Establishing harmonized systems is crucial to minimizing risks, increasing reporting of adverse events associated with dental devices. Solutions, such as, strengthening reporting infrastructure, promoting stakeholder education, and achieving cross-national regulatory convergence are imperative for advancing dental device safety and efficacy. This review underscores the critical importance of materiovigilance in ensuring the safe use of dental devices. It offers clinicians and regulatory authorities a global overview of strategies to strengthen post-market surveillance and emphasizes the urgent need for standardized adverse event reporting systems for dental materials and devices to protect patient and user safety. Global organizations e.g. World Health Organization (WHO) and the World Dental Federation (FDI) could play a pivotal role in this context, going forwards.
牙科和医疗设备是口腔医疗服务的基础；然而，由于材料创新，其使用日益增加且产品种类不断增多，这带来了不良事件的潜在风险。尽管存在监管框架，但不良事件报告不足，牙科专业人员的意识仍然较低。本综述首次对牙科设备国际材料警戒系统进行了文献比较分析，并探讨了统一的不良事件报告如何能提高其全球安全性、有效性和可靠性。我们进行了一项叙述性综述，参考了同行评审文献和监管文件。对美国、欧盟、英国、澳大利亚和印度的系统进行了比较分析，以探讨监管成熟度、地域代表性以及对全球牙科设备市场的影响方面的差异。重点关注的关键领域包括监管分类、强制报告要求、上市后监测策略以及融入临床实践。欧盟的《医疗器械法规》（MDR）、美国食品药品监督管理局（FDA）的医疗器械报告系统、英国药品和医疗产品监管局（MHRA）的报告机制、澳大利亚治疗用品管理局（TGA）的事件报告和调查计划（IRIS）以及印度的材料警戒计划（MvPI）等国际框架的研究结果表明，标准化报告机制显著提高了不良事件的检测能力，并能实现及时干预。然而，监管标准、报告规程以及利益相关者参与实践方面的差异，仍然阻碍着建立一个统一的全球牙科设备材料警戒框架。牙科领域有效的材料警戒需要监管机构、制造商、医疗保健专业人员和患者共同进行国际协调努力。建立统一的系统对于将风险降至最低、增加与牙科设备相关的不良事件报告至关重要。加强报告基础设施、促进利益相关者教育以及实现跨国监管趋同等解决方案对于提高牙科设备的安全性和有效性至关重要。本综述强调了材料警戒在确保牙科设备安全使用方面的至关重要性。它为临床医生和监管机构提供了加强上市后监测策略的全球概述，并强调迫切需要建立牙科材料和设备的标准化不良事件报告系统，以保护患者和使用者的安全。展望未来，世界卫生组织（WHO）和世界牙科联盟（FDI）等全球组织在这方面可以发挥关键作用。
