Dr Niall MacAleenan

Director of Medical Devices

Health Products Regulatory Authority (HPRA)

Niall is the Director of Medical Devices at the Health Products Regulatory Authority (HPRA) in Ireland. As a member of the HPRA’s leadership team, he is responsible for the operation and development of HPRA’s regulatory activities and capabilities for medical devices and leadership of its Medical Device Department. His work over the next number of years will focus on ensuring effective operation and consistent application in practice of the new EU Regulations on medical devices and optimising the HPRA activities for medical devices.

Niall MacAleenan qualified as a medical doctor at Trinity College Dublin in 1999. Niall worked in a variety of clinical and research roles across the Irish health care system. He also attained a business degree from University College Dublin. Since joining HPRA Niall has held a variety of different roles at senior level within the organisation both in the area of medical devices and human medicines. In 2018, Niall was appointed as the Head of Medical Devices to design, establish and lead the HPRA’s new medical devices department and the development of our team and activities to ensure HPRA is ready to apply the new EU Regulations in practice.

Niall is a leading European expert on medical devices. He represents HPRA and Ireland at the EU Medical Device Coordination Group (MDCG), the EU Regulatory Committee, the Executive Group of the Competent Authorities for Medical Devices (CAMD) network and, when required, at the European Council’s Working Party on Pharmaceuticals and Medical Devices. Niall is also a member of the European delegation to the Management Committee of the International Medical Device Regulators Forum (IMDRF).

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