Episode Details

This episode examines the UK MHRA's Device Safety Information (DSI/2026/012), issued on September 29, 2026, which details critical safety risks for wireless cardiotocography (CTG) monitoring systems. We break down the identified risks of signal crossover and dropouts, the MHRA's required actions for healthcare providers, and the significant post-market compliance and risk management implications for manufacturers of RF-enabled medical devices. Key Questions: - What specific risks did the MHRA identify for wireless CTG systems in its September 2026 safety alert? - How does signal crossover differ from signal dropout, and why are both critical safety concerns? - What actions are now required of UK healthcare professionals using these devices? - What are the immediate implications for a manufacturer's risk management file (ISO 14971)? - How should manufacturers update their Instructions for Use (IFU) and training materials in response to this alert? - Does this MHRA alert require changes to your post-market surveillance (PMS) plan? - What design considerations should engineering teams prioritize for future wireless medical devices? - How can manufacturers proactively address RF interference in a clinical setting? Sources: - https://www.gov.uk/government/publications/mhra-safety-round-up-september-2026 - https://thomson-walsh.com/mhra-september-2026-safety-roundup-new-compliance-requirements-for-medical-devices/ How Pure Global can help: Pure Global offers end-to-end regulatory consulting to help MedTech and IVD companies navigate complex global markets. Our experts can assist with updating your risk management files, refining post-market surveillance strategies, and ensuring your technical documentation meets evolving requirements like those from the UK MHRA. We combine local expertise with advanced AI to streamline market access and maintain compliance across 30+ countries. Let us help you get to market faster and stay there. Contact us at info@pureglobal.com, visit https://pureglobal.com, or explore our free AI tools and database at https://pureglobal.ai.