The role of software in society has changed drastically since the start of the twenty-first century. Software can now partially or fully facilitate diagnosis and treatment of a disease, regardless of whether it is psychological or pathological. Consequently, software plays a role comparable to medical equipment with a physical footprint. Understanding when software as a medical device must comply with applicable rules is vital for both manufacturers and regulators. We therefore examine the Medical Device Regulation to expand on the notion of intention, as this is the key basis for the classification of medical devices. Finally, we develop objective criteria that software must fulfil to be considered a medical device under European Union law.

中文翻译：

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什么时候软件是医疗设备？了解和确定欧盟法律中将软件作为医疗器械的“意图”和要求

自 21 世纪初以来，软件在社会中的作用发生了巨大变化。软件现在可以部分或完全促进疾病的诊断和治疗，无论是心理上的还是病理上的。因此，软件所起的作用可与具有物理足迹的医疗设备相媲美。了解作为医疗设备的软件何时必须遵守适用规则对于制造商和监管机构都至关重要。因此，我们检查医疗器械法规以扩展意图的概念，因为这是医疗器械分类的关键基础。最后，我们制定了软件必须满足的客观标准，才能根据欧盟法律被视为医疗设备。