Medical Device Reforms – Navigating the Impact of EU Reforms on the Reclassification of select Medical Devices in Australia
Recognising the impact of the European Union (EU) reforms from the overhaul of medical device directives (MDD) and in vitro device directives (IVD) to regulations (MDR/IVDR), Australia’s therapeutic goods regulator, the Therapeutic Goods Administration (TGA) have proactively engaged in public consultations to align Australian medical device regulations with the new EU framework. Consultations commenced in…
