- This event has passed.
The EU Medical Device Regulation State of Play
December 1, 2022 @ 12:00 pm - 1:00 pm
The new EU Medical Device Regulation (MDR), which came into effect 26 May 2021, represents the greatest change for the regulatory system in over 20 years. While the medtech industry is a proven supporter of the EU MDR’s goals, and has invested significantly into the transition process, major implementation challenges exist. The speakers will examine the impact of EU MDR on the industry particularly the SME and start up community. The panel will review the US regulatory system and the predictability it now offers. The unintended consequences of MDR on patients and physicians’ access to medtech particularly orphan devices will be examined. Senior leaders will also outline the advocacy work through the Irish Medtech Association and Medtech Europe, which is seeking a fit for purpose regulatory system and pragmatic solutions to the immediate challenges. The speakers will discuss the longer-term strategy required to ensure that Ireland remains a global medtech hub.
Chair: John Kilmartin, Vice-President of Regulatory Affairs, Medtronic
- Dr Niall MacAleenan, Director, Medical Devices, HPRA
- John O’Dea, CEO, Palliare
- Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, Trinity College Dublin
- Olga Van Grol-lawlor, Manager Global Regulatory Intelligence & Advocacy, Boston Scientific
- Dr Emer Sherry, Senior Executive, Irish Medtech Association