Regulation of Artificial Intelligence in Medical Devices in Russia: Balancing Innovation and Safety

This narrative review explores the current regulatory landscape governing the use of artificial intelligence (AI) in medical devices in Russia. It discusses how national regulations aim to balance technological innovation with patient safety and compares these approaches to international frameworks such as the EU MDR, FDA guidance, and IMDRF principles. The review highlights key challenges in standardization, clinical evaluation, and ethical oversight of AI-based medical technologies. It also outlines strategic directions for regulators, developers, and researchers to ensure responsible and effective integration of AI into medical device regulation.