AI Act’s Impact on Healthcare

AI systems will be considered medical devices if they make diagnoses, interpret medical data, or assist in therapies. These AI-based medical products will now be regulated by both the MDR and the AI Act. The MDR defines risk classifications, while the AI Act provides additional rules for high-risk AI. Both regulations require technical documentation, risk management, and quality controls. The goal is to integrate both processes smoothly to avoid redundancy. Manufacturers are advised to prepare for these requirements, which will take effect in mid-2027.