{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T06:46:19Z","timestamp":1782283579580,"version":"3.54.5"},"reference-count":42,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T00:00:00Z","timestamp":1782259200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med. Technol."],"abstract":"<jats:p>\n                    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                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20095), the integration of qualitative and structured quantitative approaches (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20093), incorporation of patient preferences (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20092), inclusion stakeholder and end-user engagement (\n                    <jats:italic>n<\/jats:italic>\n                    \u2009=\u20091), 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.\n                  <\/jats:p>","DOI":"10.3389\/fmedt.2026.1863808","type":"journal-article","created":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T05:46:36Z","timestamp":1782279996000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Reported best practices for effective risk management of medical devices: a scoping review"],"prefix":"10.3389","volume":"8","author":[{"given":"Rosario","family":"Luxardo","sequence":"first","affiliation":[{"name":"Department of Surgery and Cancer, Faculty of Medicine, Imperial College London","place":["London, United Kingdom"]},{"name":"NIHR HealthTech Research Centre in In Vitro Diagnostics","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arkeliana","family":"Tase","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Faculty of Medicine, Imperial College London","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florence","family":"Leong","sequence":"additional","affiliation":[{"name":"Health and Technology Theme, School of Convergence Science, Imperial College London","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Massimo","family":"Micocci","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Faculty of Medicine, Imperial College London","place":["London, United Kingdom"]},{"name":"NIHR HealthTech Research Centre in In Vitro Diagnostics","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Tognini","sequence":"additional","affiliation":[{"name":"Biomedical Research Centre, Biomedical Engineering Theme, Department of Bioengineering, Imperial College London","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Buckle","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Faculty of Medicine, Imperial College London","place":["London, United Kingdom"]},{"name":"NIHR HealthTech Research Centre in In Vitro Diagnostics","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melody","family":"Ni","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Faculty of Medicine, Imperial College London","place":["London, United Kingdom"]},{"name":"NIHR HealthTech Research Centre in In Vitro Diagnostics","place":["London, United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,6,24]]},"reference":[{"key":"B1","year":"2025"},{"key":"B2","volume-title":"Bioscience and Health Technology Sector Statistics 2021 to 2022","year":"2024"},{"key":"B3","year":"2020"},{"key":"B4","doi-asserted-by":"publisher","first-page":"1243","DOI":"10.1177\/09544119231203776","article-title":"Medical device regulatory challenges in the UK are affecting innovation and its potential benefits","volume":"237","author":"Beddoe-Rosendo","year":"2023","journal-title":"Proc Inst Mech Eng H"},{"key":"B5","doi-asserted-by":"publisher","first-page":"927","DOI":"10.1007\/s12265-022-10232-1","article-title":"Navigating the regulatory pathway for medical devices-a conversation with the FDA, clinicians, researchers, and industry experts","volume":"15","author":"Lottes","year":"2022","journal-title":"J Cardiovasc Transl Res"},{"key":"B6","first-page":"1","article-title":"Navigating the future: medical devices and diagnostics regulation in the UK","author":"Norell","year":"2024","journal-title":"Glob Couns Health Life Sci"},{"key":"B7","author":"Lau","year":"2024"},{"key":"B8","doi-asserted-by":"publisher","first-page":"e58936","DOI":"10.2196\/58936","article-title":"The value of smartwatches in the health care sector for monitoring, nudging, and predicting: viewpoint on 25 years of research","volume":"26","author":"Kohler","year":"2024","journal-title":"J Med Internet Res"},{"key":"B9","doi-asserted-by":"publisher","first-page":"615927","DOI":"10.3389\/fcvm.2020.615927","article-title":"Ethical challenges with smartwatch-based screening for atrial fibrillation: putting users at risk for marketing purposes?","volume":"7","author":"Predel","year":"2020","journal-title":"Front Cardiovasc Med"},{"key":"B10","first-page":"1","article-title":"Challenges of distributed risk management for medical application platforms","author":"Hatcliff","year":"2018"},{"key":"B11","doi-asserted-by":"publisher","first-page":"390","DOI":"10.1007\/978-981-10-5122-7_98","article-title":"Testing of infusion pumps in healthcare institutions in Bosnia and Herzegovina","volume":"65","author":"Gurbeta","year":"2018","journal-title":"IFMBE Proc"},{"key":"B12","year":"2021"},{"key":"B13","year":"2024"},{"key":"B14","year":"2019"},{"key":"B15","doi-asserted-by":"publisher","first-page":"e001849","DOI":"10.1136\/bmjoq-2022-001849","article-title":"Current status of medical device malfunction reporting: using end user experience to identify current problems","volume":"11","author":"Tase","year":"2022","journal-title":"BMJ Open Qual"},{"key":"B16","doi-asserted-by":"publisher","first-page":"e2231609","DOI":"10.1001\/jamanetworkopen.2022.31609","article-title":"Estimated cost of developing a therapeutic Complex medical device in the US","volume":"5","author":"Sertkaya","year":"2022","journal-title":"JAMA Netw Open"},{"key":"B17","doi-asserted-by":"publisher","first-page":"1328540","DOI":"10.3389\/fnins.2024.1328540","article-title":"Accelerating neurotechnology development using an Agile methodology","volume":"18","author":"Thota","year":"2024","journal-title":"Front Neurosci"},{"key":"B18","doi-asserted-by":"publisher","first-page":"467","DOI":"10.7326\/M18-0850","article-title":"PRISMA Extension for scoping reviews (PRISMA-ScR): checklist and explanation","volume":"169","author":"Tricco","year":"2018","journal-title":"Ann Intern Med."},{"key":"B19","year":"2021"},{"key":"B20","year":"2017"},{"key":"B21","year":"2023"},{"key":"B22","doi-asserted-by":"publisher","first-page":"2311","DOI":"10.2147\/RMHP.S306698","article-title":"An ethical risk management approach for medical devices","volume":"14","author":"Carden","year":"2021","journal-title":"Risk Manag Healthc Policy"},{"key":"B23","year":"2021"},{"key":"B24","doi-asserted-by":"publisher","first-page":"20552076241293313","DOI":"10.1177\/20552076241293313","article-title":"Considerations for regulation and evaluation of digital mental health technologies","volume":"10","author":"Hopkin","year":"2024","journal-title":"Digit Health"},{"key":"B25","doi-asserted-by":"publisher","first-page":"889","DOI":"10.1080\/17434440.2025.2517168","article-title":"Methodologies for the benefit-risk analysis of medical devices: a systematic review","volume":"22","author":"Freyer","year":"2025","journal-title":"Expert Rev Med Devices"},{"key":"B26","year":"2019"},{"key":"B27","doi-asserted-by":"publisher","first-page":"449","DOI":"10.1016\/j.jval.2022.12.006","article-title":"Quantitative benefit-risk assessment in medical product decision making: a good practices report of an ISPOR task force","volume":"26","author":"Tervonen","year":"2023","journal-title":"Value Health"},{"key":"B28","doi-asserted-by":"publisher","first-page":"349","DOI":"10.2147\/MDER.S375977","article-title":"Risk identification and analysis in the development of medical devices among start-ups: towards a broader risk management framework","volume":"15","author":"Kheir","year":"2022","journal-title":"Med Devices"},{"key":"B29","doi-asserted-by":"publisher","first-page":"19","DOI":"10.2345\/0899-8205-49.s1.19","article-title":"Best practices in applying medical device risk management terminology","volume":"49","author":"Wu","year":"2015","journal-title":"Biomed Instrum Technol"},{"key":"B30","doi-asserted-by":"publisher","first-page":"746","DOI":"10.1016\/j.jval.2016.02.019","article-title":"A framework for incorporating patient preferences regarding benefits and risks into regulatory assessment of medical technologies","volume":"19","author":"Ho","year":"2016","journal-title":"Value Health"},{"key":"B31","doi-asserted-by":"publisher","first-page":"467","DOI":"10.1080\/17434440.2023.2184685","article-title":"Artificial intelligence in medical device software and high-risk medical devices\u2014a review of definitions, expert recommendations and regulatory initiatives","volume":"20","author":"Fraser","year":"2023","journal-title":"Expert Rev Med Devices"},{"key":"B32","doi-asserted-by":"publisher","first-page":"217","DOI":"10.1080\/17434440.2024.2315024","article-title":"Towards an evaluation framework for medical device-integrated electronic medical record","volume":"21","author":"Alhammad","year":"2024","journal-title":"Expert Rev Med Devices"},{"key":"B33","doi-asserted-by":"publisher","first-page":"26","DOI":"10.2345\/0899-8205-49.s1.26","article-title":"Documenting medical device risk management through the risk traceability summary","author":"Bills","year":"2015","journal-title":"Biomed Instrum Technol"},{"key":"B34","doi-asserted-by":"publisher","first-page":"e26942","DOI":"10.2196\/26942","article-title":"Using medical device standards for design and risk management of immersive virtual reality for at-home therapy and remote patient monitoring","volume":"6","author":"Salisbury","year":"2021","journal-title":"JMIR Biomed Eng"},{"key":"B35","year":"2020"},{"key":"B36","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1136\/bmjinnov-2024-001238","article-title":"Guidelines and regulations applicable to vitro diagnostic tests in the UK: a scoping review","volume":"10","author":"Staworko","year":"2024","journal-title":"BMJ Innov"},{"key":"B37","year":"2024"},{"key":"B38","author":"Mkwashi","year":"2022"},{"key":"B39","doi-asserted-by":"crossref","DOI":"10.1145\/3567445.3571104","article-title":"Risk assessment and classification of medical device software for the internet of medical things: challenges arising from connected, intelligent medical devices","author":"Brass","year":"2022"},{"key":"B40","author":"Taylor","year":"2018"},{"key":"B41","year":"2025"},{"key":"B42","year":"2015"}],"container-title":["Frontiers in Medical Technology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmedt.2026.1863808\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T05:46:37Z","timestamp":1782279997000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmedt.2026.1863808\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,24]]},"references-count":42,"alternative-id":["10.3389\/fmedt.2026.1863808"],"URL":"https:\/\/doi.org\/10.3389\/fmedt.2026.1863808","relation":{},"ISSN":["2673-3129"],"issn-type":[{"value":"2673-3129","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,24]]},"article-number":"1863808"}}