TEAM NB POSITION PAPER PUBLISHED: WHAT IVD MANUFACTURERS NEED TO KNOW ABOUT COMBINATORIAL USE
MDR & IVDR Proposed Revisions Published on 02/03/2026 The proposed updates to the MDR and IVDR are designed to enhance regulatory efficiency, foster transparency, and streamline innovation pathways for medical device manufacturers. While the shift toward digital documentation and improved regulatory communication holds promise, there are concerns about the potential reduction in oversight and its […]
Mandatory TGA Adverse Event Reporting: A New Era of Vigilance for Australian Healthcare
SYDNEY, 18, FEB 2026 – The landscape of medical device safety in Australia has officially shifted. On March 21, 2026, the Therapeutic Goods Administration (TGA) moved from a voluntary reporting culture for hospitals to a strict, mandatory framework. This regulatory evolution, driven by the findings of the 2017-18 Senate Inquiry into transvaginal mesh implants, aims […]