Global regulation of surgical AI devices: assessing cross-border compatibility in the United States, Europe, United Kingdom, and China

Abstract

Regulation plays a pivotal role in shaping the adoption of AI-based surgical tools to enhance patient care. However, differences in global regulatory frameworks can influence how quickly and safely these surgical AI devices reach clinical practice. This article compares the regulatory landscapes of the United States (US), European Union (EU), United Kingdom (UK), and China, and examines how their respective regulatory authorities approach the approval of surgical AI devices, including those used for preoperative risk stratification and planning, intraoperative navigation and computer vision, and postoperative monitoring. While all jurisdictions follow a risk-based paradigm, key differences centre on classification thresholds, pathways for approval, clinical evidence requirements, and the pace of market entry. The US Food and Drug Administration (FDA) relies heavily on the 510(k) process, facilitating moderate-risk device clearances at a rapid pace, though concerns persist regarding predicate creep for iteratively evolving algorithms. Manufacturers seeking approval in Europe must navigate the Medical Device Regulation (MDR) and the emerging requirements of the EU AI Act, which introduce additional obligations for high-risk AI systems. The UK continues to shape its framework post-Brexit under the Medicines and Healthcare products Regulatory Agency (MHRA), including through novel oversight models such as the AI Airlock regulatory sandbox. In China, the National Medical Products Administration (NMPA) designates most decision-support AI tools as high-risk, increasing approval scrutiny but potentially slowing market entry. This comparative analysis underscores a growing need for transparency and international collaboration to enhance patient safety, anticipate evolving technologies, and ensure that the potential of AI is realised in global surgical practice.

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