TGA “Boundary Products” Rules Officially Updated
Australia, 16 December 2025 — The Therapeutic Goods Administration (TGA) has formally published updated guidance and legislative instruments regarding the regulation of “Boundary and Combination Products“. These changes, finalized in the Therapeutic Goods (Medical Devices Specified Articles) Amendment Instrument 2025, represent a significant shift in how the TGA classifies products that sit on the border […]
MDCG 2025-10 Published: The New Standard for Proactive Post-Market Surveillance
EUROPE, 20 DEC 2025 — The Medical Device Coordination Group (MDCG) has officially released MDCG 2025-10: Guidance on post-market surveillance of m edical devices and in vitro diagnostic medical devices. This long-awaited document provides the definitive interpretation of Post-Market Surveillance (PMS) requirements under Article 83 of the MDR and Article 78 of the IVDR. For […]