Speakers - Dr Niall MacAleenan

Dr Niall MacAleenan
Director of Medical Devices at the Health Products Regulatory Authority (HPRA)
Niall is the Director of Medical Devices at the Health Products Regulatory Authority (HPRA). He has responsibility for the authority’s activities to ensure the safety and compliance of medical devices in Ireland.
In tandem with this work at national level, Niall is extensively involved at European level as a member of the Medical Device Coordination Group (MDCG) and of the Executive Group of the EU Competent Authorities for Medical Devices (CAMD). Having been part of the Irish delegation at the European Council throughout the negotiations of the new medical device Regulations, Niall remains committed to ensure that implementation and application of the Regulations is effective both at EU and national level. His aim is that the Regulations achieve their stated objectives of increasing safety while supporting innovation while enabling a robust, transparent, predictable, and sustainable regulatory system in Europe.
Niall is a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF) promoting collaboration, harmonisation, and convergence internationally. Niall holds a degree from the UCD Smurfit Graduate Business School and a medical degree from Trinity College Dublin. Before joining HPRA, Niall working in a variety of clinical and research roles in the Irish health system.