Reported best practices for effective risk management of medical devices: a scoping review

Risk management (RM) is an essential element for developing safe technologies and frequently a requirement by the regulators. The practice of RM spans from pre-to-post market stages, starting from product development and continuing after product launch. Technological advancements and shifting demands in healthcare led to rapid growth of new technologies such as AI, robotics and point of care diagnostics, presenting many unknowns to the RM process. This study aims to review best practices in medical device RM, highlight gaps and ambiguities in knowledge and identify priorities for future research. A thorough literature review was conducted in June 2025 in two parts: (A) assessment of official updated regulatory documents and guidelines for Medical Devices (MDs), and (B) review published literature for reported best practices in RM of MDs. Part A of the search focused on official regulatory agencies, and Part B of the search was conducted on OVID, Embase, Medline, PubMed, Engineering Village, Scopus, and Google Scholar. A 10-year and English as language limit was applied only for part B. Our search found 147 publications (16 were guidelines from regulatory agencies and 131 were from peer reviewed literature). A total of one regulatory document and 11 studies met the inclusion criteria. Step (A) ISO 14971 was the only regulatory document that explicitly described a structured process for RM. Step (B) Although no single best practice was identified, several recurring themes emerged. Significant best practices suggest the use of hybrid or multi-component frameworks (n = 5), the integration of qualitative and structured quantitative approaches (n = 3), incorporation of patient preferences (n = 2), inclusion stakeholder and end-user engagement (n = 1), and considerations of emerging system-level challenges, such as cybersecurity, was limited. Based on our findings, we advise targeted recommendations to strengthen current practices. In conclusion, many challenges exist in conducting an efficient RM process for medical devices, driven by variability in technology and specifications, which will increase as these technologies continue to evolve. Greater end-user involvement throughout all stages can help identify unknown hazards and improve medical technology safety.