This article examines whether the EU Medical Device Regulation (MDR) adequately addresses the novel risks of AI-based medical devices (AIaMDs), focusing on AI medical imaging tools. It examines two questions: first, does the MDR effectively deal with issues of adaptability, autonomy, bias, opacity, and the need of trustworthiness of AIaMD? Second, does the manufacturer’s translation of the MDR’s requirements close a discrepancy between an AIaMDs’ expected benefit and the actual clinical utility of assessing device safety and effectiveness beyond the narrow performance of algorithms? While the first question has previously received attention in scholarly literature on regulatory and policy tensions on AIaMD generally, and work on future technical standard setting, the second has been comparatively overlooked. We argue that effective regulation of AIaMD requires framing notions of patient safety and benefit within the manufacturer’s articulation of the device’s intended use, as well as reconciling tensions. These tensions are on (i) patient safety and knowledge gaps surrounding fairness, (ii) trustworthiness and device effectiveness, (iii) the assessment of clinical performance, and (iv) performance updates. Future guidance needs to focus on the importance of translated benefits, including nuanced risk framing and looking at how the limitations of AIaMD inform the intended purpose statement in the MDR.

中文翻译：

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人工智能如何挑战医疗器械监管：患者安全、益处和预期用途

本文探讨了欧盟医疗器械法规 (MDR) 是否充分解决了基于人工智能的医疗器械 (AIaMD) 的新风险，重点关注人工智能医疗成像工具。它考察了两个问题：第一，MDR 是否有效地处理了 AIaMD 的适应性、自主性、偏见、不透明性和可信度需求等问题？其次，制造商对 MDR 要求的翻译是否消除了 AIaMD 的预期效益与评估设备安全性和有效性（超越算法的狭隘性能）的实际临床效用之间的差异？虽然第一个问题此前已在有关 AIaMD 监管和政策紧张局势以及未来技术标准制定工作的学术文献中受到关注，但第二个问题相对被忽视了。我们认为，对 AIaMD 的有效监管需要在制造商阐明设备的预期用途以及协调紧张关系的范围内构建患者安全和利益的概念。这些紧张关系在于（i）患者安全和公平性方面的知识差距，（ii）可信度和设备有效性，（iii）临床表现评估，以及（iv）表现更新。未来的指导需要关注转化效益的重要性，包括细致入微的风险框架，以及研究 AIaMD 的局限性如何体现 MDR 中的预期目的声明。