论文标题
软件何时是医疗设备？理解和确定软件作为欧盟法律医疗设备的“意图”和要求
When is Software a Medical Device? Understanding and Determining the 'Intention' and Requirements for Software as a Medical device in EU law
论文作者
论文摘要
自21世纪初以来，软件在社会中的作用发生了巨大变化。现在，软件可以部分或完全促进从诊断到治疗疾病的任何事物，无论它是心理还是病理，因此软件与任何其他类型的医疗设备都相当，这使得在软件必须遵守对制造商和监管机构至关重要的此类规则时发现。为了代替医疗设备法规，我们扩展了意图的想法，确定标准软件必须实现才能被视为欧盟法律中的医疗设备。
The role of software in society has changed drastically since the start of the 21st century. Software can now partially or fully facilitate anything from diagnosis to treatment of a disease, regardless of whether it is psychological or pathological, with the consequence of software being comparable to any other type of medical equipment, and this makes discovering when software must comply with such rules vital to both manufacturers and regulators. In lieu of the Medical Device Regulation we expand on the idea of intention, and identify the criteria software must fulfil to be considered medical devices within EU-law.
