We are pleased to announce our next i4KIDS I i4KIDS4RARE Training Capsule, featuring Dr. Gearóid McGauran, Medical Officer at the Health Products Regulatory Authority (HPRA), Ireland’s national competent authority for medical devices.
Dr. McGauran is a leading expert in the regulatory landscape for orphan medical devices. He was the lead author of MDCG 2024-10, the key EU guidance on the clinical evaluation of orphan devices, and is a member of both the MDCG Orphan Device Taskforce and the MDCG Clinical Investigation and Evaluation (CIE) Working Group. He also contributed to the CORE-MD research consortium. With a background in medicine, he is a Member of the Royal College of Physicians of Ireland (RCPI) Faculty of Paediatrics and holds a master’s degree in advanced healthcare practice and research from the University of Galway.
📅 Date: 27th March
⏰ Time: 13:00 – 14:00 (CET)
💻 Format: Online
During this session, Dr. McGauran will delve into key considerations for generating clinical evidence for orphan medical devices, including aspects of clinical investigations and available regulatory support within the EU framework. His presentation will be primarily based on the MDCG 2024-10 guidance, which he led in its development.
