UK MHRA Wireless CTG Safety Alert: Post-Market Actions for Manufacturers

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-10-05

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...