Biography
Tom Melvin is Associate Professor of Medical Device Regulatory Affairs in Trinity College Dublin. Prior to this, Tom worked as a senior medical officer in medical devices at the Health Products Regulatory Authority, where he served for 7 years.
Tom Co-chaired the Clinical Investigation and Evaluation Working Group of the European Commission for 5 years. Tom has led various taskforces, work packages and projects at national and international level on regulatory and scientific topics related to medical device regulation.
Tom is a member of the International Rare Disease Research Consortium (IRDiRC) working group on MedTech for rare diseases, and a member of the National Research Ethics Committee for Medical Devices in Ireland. Before working in medical devices, Tom worked as a medical doctor for a number of years.
Publications and Further Research Outputs
Peer-Reviewed Publications
Olamide Sadare; Tom Melvin; Hugh Harvey; Erik Vollebregt; Stephen Gilbert, Can Apple and Google continue as health app gatekeepers as well as distributors and developers?, npj Digital Medicine, 6, (8), 2023
Gilbert S, Anderson S, Daumer M, Li P, Melvin T, Williams R, Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies, Journal of internet medical research, 25, 2023, pe43682-
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szyma"ski P, Melvin T, Piscoi P, CORE-MD Investigators, Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)., European heart journal. Quality of care & clinical outcomes, 2022, pdoi: 10.1093/ehjqcco/qcab059
Melvin T, Kenny D, Gewellig M, Fraser AGF, Orphan Medical Devices and Pediatric Cardiology " What Interventionists in Europe Need to Know, and What Needs to be Done, Pediatric Cardiology, 2022
Tom Melvin, The European Medical Device Regulation - what biomedical engineers need to know, IEEE Journal of Translational Engineering in Health and Medicine, 2022, p10.1109/JTEHM.2022.3194415
Fraser AG, Nelissen RGHH, Kjærsgaard-Andersen P, Szyma"ski P, Melvin T, Piscoi P, CORE"MD Investigators (see Appendix), Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)., EFORT open reviews, 2021
Melvin T, Torre M, New medical device regulations: the regulator's view., EFORT open reviews, 2019
Non-Peer-Reviewed Publications
Regulatory Assessment of Medical Devices in the European Union in, Translational Pathways for Cardiovascular Devices, 2016, [ Alan G. Fraser, MD; Robert A. Byrne, PhD; Tom Melvin, MD; Niall MacAleenan, MD; Olga Tkachenko, PhD; Paul Piscoi, MD]
Global Health, New Challenges in, editor(s)Michal Cenker, Louiza Hadjivasiliou, Patrick Marren and Niamh Rooney , Development Education in Theory and Practice: An educator's resource, 2015, [Tom Melvin]
Research Expertise
Description
Medical devices, medical device regulation, clinical researchRecognition
Representations
European Union Representative at the Working Group on Medical Device Clinical Evaluation, International Medical Device Regulators Forum (IMDRF)
Awards and Honours
Irish Intercollegiate Global Health Competition - James Deeny Medal, The Lancet Student, Dublin, Ireland
Global Health Young Leaders Award, Royal Society of Medicine, London, United Kingdom
Memberships
National Research Ethics Committee for Medical Devices, National Research Ethics Committee , Dublin, IE