The Role of Medical Device Software in EU Healthcare
THE FUTURE OF HEALTHCARE IS SOFTWARE—HERE’S HOW THE EU REGULATES IT Medical Device Software (MDSW) is becoming essential in EU healthcare, especially as hospitals and patients rely more on digital tools for diagnosis, monitoring, and clinical decision-making. Under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746), any software used […]
IMDRF Launches Public Consultation on Predetermined Change Control Plans (PCCPs) for SaMD
Therapeutic Goods Administration (TGA), November 12, 2025 – The International Medical Device Regulators Forum (IMDRF) has released a pivotal draft guidance titled “Essential Principles and Content of Predetermined Change Control Plans (PCCPs)”, marking a significant development in how software-based medical devices (SaMD) will be regulated across global jurisdictions.This draft, now open for public consultation until […]
New TGA Regulation Requires Online Supply Form for Therapeutic Vaping Goods Starting November 2025
Canberra, 13 November 2025 — The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health, Disability and Ageing, has officially approved a new regulatory instrument mandating the use of an online supply information form for all therapeutic vaping goods. This change is part of the broader implementation strategy aimed at tightening control and […]