{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,21]],"date-time":"2025-10-21T15:35:21Z","timestamp":1761060921320,"version":"3.40.5"},"reference-count":5,"publisher":"Walter de Gruyter GmbH","issue":"5-6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,10,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>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.<\/jats:p>","DOI":"10.1515\/itit-2019-0026","type":"journal-article","created":{"date-parts":[[2019,11,26]],"date-time":"2019-11-26T09:02:37Z","timestamp":1574758957000},"page":"211-218","source":"Crossref","is-referenced-by-count":6,"title":["Digital health \u2013 Software as a medical device in focus of the medical device regulation (MDR)"],"prefix":"10.1515","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1378-8728","authenticated-orcid":false,"given":"Kurt","family":"Becker","sequence":"first","affiliation":[{"name":"178432 APOLLON Hochschule der Gesundheitswirtschaft , Bremen , Germany"}]},{"given":"Myriam","family":"Lipprandt","sequence":"additional","affiliation":[{"name":"University-Hospital RWTH Aachen , Institut for Medical Informatics , Aachen , Germany"}]},{"given":"Rainer","family":"R\u00f6hrig","sequence":"additional","affiliation":[{"name":"University-Hospital RWTH Aachen , Institut for Medical Informatics , Aachen , Germany"}]},{"given":"Thomas","family":"Neumuth","sequence":"additional","affiliation":[{"name":"Universit\u00e4t Leipzig , Innovation Center Computer Assisted Surgery (ICCAS) , Leipzig , Germany"}]}],"member":"374","published-online":{"date-parts":[[2019,11,26]]},"reference":[{"key":"2023033120044231215_j_itit-2019-0026_ref_001_w2aab3b7c31b1b6b1ab2ab1Aa","unstructured":"MDR 2017: https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32017R0745 (Zugriff 01.06.2019)."},{"key":"2023033120044231215_j_itit-2019-0026_ref_002_w2aab3b7c31b1b6b1ab2ab2Aa","unstructured":"MDR_Factsheet (2019). Factsheet for Manufacturers of Medical Devices. https:\/\/ec.europa.eu\/docsroom\/documents\/31201 (Zugriff 01.06.2019)."},{"key":"2023033120044231215_j_itit-2019-0026_ref_003_w2aab3b7c31b1b6b1ab2ab3Aa","unstructured":"ZLG_309_1010_B_16 (2010) Antworten und Beschl\u00fcsse 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)."},{"key":"2023033120044231215_j_itit-2019-0026_ref_004_w2aab3b7c31b1b6b1ab2ab4Aa","unstructured":"Johner Institut f\u00fcr 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)."},{"key":"2023033120044231215_j_itit-2019-0026_ref_005_w2aab3b7c31b1b6b1ab2ab5Aa","doi-asserted-by":"crossref","unstructured":"Golatowski, Frank, Armin Jan\u00df, Martin Leucker, und Thomas Neumuth. \u201eOR.NET \u2013 secure dynamic networks in the operating room and clinic\u201c. Biomedical Engineering \/ Biomedizinische Technik 63, Nr.\u20091 (2018): 1\u20133.","DOI":"10.1515\/bmt-2018-0004"}],"container-title":["it - Information Technology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.degruyter.com\/view\/j\/itit.2019.61.issue-5-6\/itit-2019-0026\/itit-2019-0026.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/itit-2019-0026\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/itit-2019-0026\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,1]],"date-time":"2023-04-01T08:13:23Z","timestamp":1680336803000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/itit-2019-0026\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,1]]},"references-count":5,"journal-issue":{"issue":"5-6","published-online":{"date-parts":[[2019,11,22]]},"published-print":{"date-parts":[[2019,10,25]]}},"alternative-id":["10.1515\/itit-2019-0026"],"URL":"https:\/\/doi.org\/10.1515\/itit-2019-0026","relation":{},"ISSN":["2196-7032","1611-2776"],"issn-type":[{"type":"electronic","value":"2196-7032"},{"type":"print","value":"1611-2776"}],"subject":[],"published":{"date-parts":[[2019,10,1]]}}}