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.
About the authors
Prof. Dr.-Ing. Kurt Becker studied Electrical Engineering at Aachen University of Technology (RWTH Aachen) (Diplom 1991, Promotion 1996). He was member of the scientific staff of Prof. Dr. med. Günter Kalff (1991–1994, Clinic for Anaesthesiology RWTH Aachen) and Prof. Dr. rer. nat. Günther Rau (1994–1996, Helmholtz Institute for Biomedical Engineering) where he leads a project in the field of medical technology, anesthesia and medical computer science at the University Hospital Aachen (UKA). In 1996 he did his Ph. D. on Artificial Intelligence (AI) and knowledge-based decision support in medicine. He has held senior management positions in the healthcare industry. In 2008, he took responsibility for the technical and content-related responsibility for health technology at the APOLLON University of Health Economics and in 2010 was appointed professor for IT in the health industry.
Dr.-Ing. Myriam Lipprand is a computer scientist specialized on medical informatics. After finishing her doctoral thesis at OFFIS (Oldenburg Institut for Computer Science) she was Lecturer at the Jade Hochschule and Post-Doc-Scientist at the Department for Medical Informatics at the Carl von Ossietzky University Oldenburg. She is currently deputy of the Institut of Medical Informatics at the University Hospital RWTH Aachen and head of the department for “Medical Software Engineering (MSE)”. Her scientific interest is the medical socio technical systems, including regulatory affairs. She is speaker of the project group “Software as a medical device” in the German association for medical informatics, biometry and epidemiology. (GMDS)
Prof. Dr. Rainer Röhrig studied computer science (Rheinische Friedrich Willhelm University Bonn) and medicine (Justus-Liebig University, Giessen and Albertus Magnus University, Cologne). He worked as a physican and scientist in medical Informatics at the department of anaesthesiology and intensive care medicine at the University Hospital Giessen. 2014 he got full professor for Medical Informatics at the Carl von Ossietzky University Oldenburg. Since 2019 he is Full Professor at the RWTH Aachen and director of the Institut of Medical Informatics at the University-Hospital RWTH Aachen. He is engaged in several scientific societies, e. g. member of the Medical Informatics board in the German association for medical informatics, biometry and epidemiology. (GMDS) or Member of the executive Board in the TMF e.V.
Prof. Dr. Thomas Neumuth is engineer and computer scientist. He studied Electrical Engineering Management (2001) and Automation Engineering (2005) at the University of Applied Sciences Leipzig and received his doctorate in Medical Engineering (2009) and his habilitation in Medical Informatics (2012) from the University of Leipzig. He is currently deputy executive director of the Innovation Center Computer Assisted Surgery (ICCAS) at the Medical School of the University of Leipzig and Deputy Chairman of the medical device interoperability association OR.NET. He is engaged in several professional societies, such as the German Society of Medical Informatics (GMDS), the German Association of Engineers (VDE), the Society for Biomedical Engineering (DGBMT), and the Society of Computer- and robot-assisted Surgery (CURAC).
1. MDR 2017: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745 (Zugriff 01.06.2019).Search in Google Scholar
2. MDR_Factsheet (2019). Factsheet for Manufacturers of Medical Devices. https://ec.europa.eu/docsroom/documents/31201 (Zugriff 01.06.2019).Search in Google Scholar
3. ZLG_309_1010_B_16 (2010) Antworten und Beschlüsse des EK-Med: Zertifizierung von OEM-Produkten, https://www.zlg.de/index.php?eID=dumpFile&t=f&f=465&token=05c2143abd69f096b29c321c28009ef9072be7bc (Zugriff: 01.06.2019).Search in Google Scholar
4. Johner Institut für IT im Gesundheitswesen (2019). OEM (Original Equipment Manufacturer) von Medizinprodukten. https://www.johner-institut.de/blog/regulatory-affairs/oem-original-equipment-manufacturer/ (01.06.2019).Search in Google Scholar
5. Golatowski, Frank, Armin Janß, Martin Leucker, und Thomas Neumuth. „OR.NET – secure dynamic networks in the operating room and clinic“. Biomedical Engineering / Biomedizinische Technik 63, Nr. 1 (2018): 1–3.10.1515/bmt-2018-0004Search in Google Scholar PubMed
© 2019 Walter de Gruyter GmbH, Berlin/Boston