The EU AI Act and its impact on the medical device industry

The Medical Device Regulation (MDR) sets stringent requirements for medical devices, emphasizing safety, performance, and risk management. The EU AI Act is reshaping the landscape for AI-based medical devices in Europe by providing a unified framework for AI systems, from development through marketing and use, based on a proportionate risk-based approach. Under the definition of an artificial intelligence system, many software products classified as medical devices, even those already on the market, will be considered AI systems for the purposes of the AI Act and will therefore need to comply with its requirements. The EU AI Act will introduce additional obligations, particularly around transparency, accountability, and data governance. This will add complexity to the regulatory process for bringing medical devices to the European market, making it essential for manufacturers to integrate both MDR and AI Act requirements into their quality management systems.