Swissmedic Issues Minor Update to Guidance on User Incident Reporting
Swissmedic updates guidance on medical device incident reporting. Key timelines, obligations, and implications for manufacturers explained.
Swissmedic Publishes “Good Practice for Materiovigilance in Hospitals” (GPMV-Spital)
Swissmedic releases GPMV-Spital, a new framework for materiovigilance in hospitals. Understand the impact on medical device manufacturers and post-market surveillance.
MDCG 2025-8 Rev.1: Guidance on Master UDI-DI for Spectacle Devices
MDCG 2025-8 Rev.1 provides guidance on Master UDI-DI implementation for spectacle frames, lenses, and reading spectacles under EU MDR. Learn key requirements, timelines, and assignment rules.
MHRA Updates Guidance on Regulation of Medical Devices in Northern Ireland
MHRA updates guidance on medical device regulation in Northern Ireland. Key impacts for manufacturers under EU MDR and IVDR.