Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR

Dr Tom Melvin is clinical manager and part of the high level management team of medical devices at the HPRA. Prior to this, Tom worked for the HPRA as a medical officer in medical devices. Tom holds a degree in medicine, from the Royal College of Surgeons in Ireland, in addition to a degree and masters in law from University College Dublin. Tom is Co-Chair of the Clinical Investigation and Evaluation Working Group, and in addition to chairing, Tom has led a number of taskforces at CIE, and a number of other Working Groups and European Taskforces.