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Digital health – Software as a medical device in focus of the medical device regulation (MDR)

dc.contributor.authorBecker, Kurt
dc.contributor.authorLipprandt, Myriam
dc.contributor.authorRöhrig, Rainer
dc.contributor.authorNeumuth, Thomas
dc.date.accessioned2021-06-21T12:20:11Z
dc.date.available2021-06-21T12:20:11Z
dc.date.issued2019
dc.description.abstractThe Medical Device Directive (MDD) will be replaced on 26.05.2020 by the new Medical Device Regulation (MDR). The European Parliament wants to create a transparent, solid, predictable and sustainable legal framework. One of the major upcoming changes effects the perspective on software as a medical device. This paper describes the fundamental relationships between the policy framework and the challenges faced by manufacturers and operators of medical devices, in particular medical software and artificial intelligence (AI) systems, who need to verify compliance. To address this topic, we review and discuss the main implications of medical device regulations on software as a medical device and digital health applications along the MDR structure. Furthermore, we address practical limitations of the implementation, such as the availability of notified bodies and costs of the approval procedure.en
dc.identifier.doi10.1515/itit-2019-0026
dc.identifier.pissn2196-7032
dc.identifier.urihttps://dl.gi.de/handle/20.500.12116/36665
dc.language.isoen
dc.publisherDe Gruyter
dc.relation.ispartofit - Information Technology: Vol. 61, No. 5-6
dc.subjectmedical device legislation
dc.subjectsoftware/legislation and jurisprudence
dc.subjectsoftware as a medical device
dc.subjectmedical software
dc.subjectregulatory affairs
dc.subjectmedical device regulation
dc.titleDigital health – Software as a medical device in focus of the medical device regulation (MDR)en
dc.typeText/Journal Article
gi.citation.endPage218
gi.citation.publisherPlaceBerlin
gi.citation.startPage211

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