Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published an updated guidance document dedicated to personalized medical devices (including 3D-printed devices). The document constitutes a...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices and other healthcare products, has published an official information notice dedicated to custom-made medical devices. The notice is intended to provide...
EU MDR/IVDR
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document detailing how medical device accessories should be described in submissions. The document also provides additional...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission composed of the representatives of all Member States, has published a questions and answers document dedicated to custom-made medical devices. The document also describes the...
MHRA
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance dedicated to the custom-made medical devices and applicable regulatory framework. The scope of the document covers all custom-made medical devices, including the active...
