Guiding Principles on Transparency for Machine Learning Medical Devices
In a significant move toward enhancing the safety and efficacy of machine learning-enabled medical devices (MLMDs), regulatory bodies from the United States, Canada, and the United Kingdom have jointly released new guiding principles focused on transparency throughout the life cycle of MLMDs. The U.S. Food and Drug Administration (FDA), Health Canada, and the UK’s Medicines and […]
EU Publishes Regulation (EU) 2024/1860 Amid Device Supply Chain Concerns
In response to increasing concerns over supply chain stability and its impact on healthcare delivery, on June 13, 2024 the European Union published Regulation (EU) 2024/1860 of the European Parliament and of the Council which amends both the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to introduce new obligations for companies facing […]
MDCG Revises Guidance on Classification for In Vitro Diagnostics
In a move poised to reshape the regulatory landscape for in vitro diagnostics (IVDs) across Europe, the Medical Device Coordination Group (MDCG) has released new guidance on classification rules. This July 8, 2024 update is the third revision of the guidance and aims to bring clarity and consistency to the classification of IVDs, ensuring that […]
Revised User Fees Guidance on for Combination Products
The U.S. Food and Drug Administration (FDA) has issued its final guidance on user fees for combination products. This new guidance released in July 2024 replaces the previous version from April 2005 and is set to further streamline the regulatory process for combination products. The move is aimed at clarifying the user fee structure and […]
TGA Considering Regulatory Governance of Integrating Assistive Technologies
The Therapeutic Goods Administration (TGA) is reaching out to stakeholders for feedback on a significant initiative that could reshape the landscape of medical technology in Australia. This initiative focuses on incorporating assistive technologies into the existing medical technology (MedTech) framework by treating them as consumer goods, rather than therapeutic goods. Assistive technologies are devices or […]
