We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Digital health – Software as a medical device in focus of the medical device regulation (MDR).
- Authors
Becker, Kurt; Lipprandt, Myriam; Röhrig, Rainer; Neumuth, Thomas
- Abstract
The 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.
- Subjects
EUROPEAN Parliament; MEDICAL software; MEDICAL equipment; ARTIFICIAL intelligence; GOVERNMENT regulation
- Publication
IT: Information Technology, 2019, Vol 61, Issue 5, p211
- ISSN
1611-2776
- Publication type
Article
- DOI
10.1515/itit-2019-0026