The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonisation and convergence. IMDRF produces guidance documents aiming at the facilitation of work of regulators and economic operators at global level.
At the Berlin meeting on 25-26 September 2023, Prof. Berthold Koletzko, Professor of Paediatrics, LMU University Hospitals, addressed the issue of paediatric devices and referred to the work performed in the framework of CORE-MD. He notably pointed to the need to develop specific rules for paediatric devices in the context of the implementation of the European medical device regulation.
More info on this event is available here.