Strengthening Dental Materiovigilance: A Review of International Reporting Frameworks

Abstract

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.

Keywords: Adverse event reporting; Dental devices; Materiovigilance; Patient safety; Regulatory frameworks.