Terhechte Arno
Bezirksregierung Münster, Domplatz 1-3, 48143, Münster, Deutschland.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2018 Mar;61(3):321-327. doi: 10.1007/s00103-017-2683-x.
Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.
根据《医疗器械指令》93/42/EEC，软件可被归类为医疗器械。软件产品和医疗应用程序的数量在持续增加，其在医疗机构（如医院和诊所）用于诊断和治疗的情况也在增多。本文从监管机构的角度介绍了独立软件和医疗应用程序的不同方面。讨论了为对制造商建立基于风险的系统检查和监督而实施的质量体系。概述了作为检查依据的法律框架以及其他标准。文章强调了检查过程中出现的特殊方面，如软件和接口的验证以及软件的临床评估。北莱茵-威斯特法伦州的地方政府机构——行政区政府也负责对医疗机构进行检查。因此，本文不仅限于将软件投放市场的制造商，还描述了医院中作为医疗器械的软件的管理和使用情况。未来的法律框架——《医疗器械法规》，将加强要求，并在医疗器械软件的合格评定中比现在更多地让公告机构参与进来。制造商、医疗机构、公告机构和负责的监管机构都需要加大对医疗器械软件的工作力度。相互交流信息、提高技能以及进行检查将有助于符合监管要求。
