MedTech's Sustainability Dilemma: Reprocessing, Risk, and the Future of Single-Use Devices

Medical Device Global Market Access · Feb 10, 2026 · 3m

This episode explores the growing tension between single-use medical devices and the push for sustainability. We delve into the complex world of reprocessing, examining the regulatory hurdles, validation requirements, and critical liability shifts under frameworks like the US FDA and the EU's Medical Device Regulation (MDR). We discuss how this trend impacts manufacturers, from Instructions for Use (IFU) to risk management, and what the future holds as the circular economy reshapes MedTech business models. Key Questions: - When is a single-use device no longer single-use? - Who becomes the…