The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.

中文翻译：

---

浏览欧盟人工智能法案：对受监管数字医疗产品的影响


新通过的欧盟人工智能法案是一个关键的里程碑，预示着跨行业人工智能监管的新时代。凭借其广泛的地域范围和适用性，这项全面的立法对人工智能系统提出了严格的要求。在本文中，我们分析了《人工智能法案》对医疗设备等数字医疗产品的影响：《人工智能法案》如何适用于支持人工智能/机器学习的医疗设备？它们是如何分类的？合规要求是什么？而且，这些人工智能系统的“提供者”有哪些义务？在解决这些基本问题后，我们讨论了《人工智能法案》对受监管数字医疗产品未来的更广泛影响。