Over 40 participants attended a CRDI/CÚRAM Partnership workshop on EU Regulation of Medical Devices (EURMD) in the CÚRAM Research Centre, NUIG, Tuesday 19th March 2019.
The workshop facilitated by Dr. Anne-Marie Miller (CRDI), was case study based and designed to encourage interaction with medical device regulatory experts. It described regulatory requirements relevant to the entire life cycle of medical device development from the perspectives of the competent authority and notified bodies. Guest speakers on the day included Dr. Tom Melvin, Medical Officer, HPRA and Mr. Colm O’Rourke, Business Development Officer, NSAI. Topics included regulatory considerations governing clinical strategy relating to device development as well as an overview of regulatory processes for CE marking with particular reference to the Medical Device Regulations (MDR), their scope and potential to impact device innovation and ambition for market.
The EURMD workshop was the second of two delivered as part of the CRDI e-Learning course ‘Fundamentals in Medical Device Design and Regulation’. Further details on this course and the CRDI/CÚRAM Partnership can be found at https://www.crdi.ie/research-curam/
The CRDI / CÚRAM Partnership project is funded by Science Foundation Ireland (SFI) and the European Regional Development Fund (Grant Number 13/RC/2073)