{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,1,22]],"date-time":"2024-01-22T23:13:35Z","timestamp":1705965215537},"reference-count":0,"publisher":"IOS Press","license":[{"start":{"date-parts":[[2022,6,29]],"date-time":"2022-06-29T00:00:00Z","timestamp":1656460800000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,6,29]]},"abstract":"<jats:p>There exist numerous low-risk class I SaMDs with CE marking under European Medical Device Directives (MDD). However, if the manufacturers will make any significant change to these class I SaMDs, the manufacturers shall comply with Medical Device Regulation (MDR) 2017\/745 classifications. Class I SaMDs are self-declared without the need for notified body involvement. It is unclear how these devices are monitored if they will undergo any significant changes. Significant change may shift existing low-risk class I SaMDs to higher risk classification. In another hand, it is not clear if all class I SaMDs that are certified under MDD are registered with relevant EU Competent Authorities. Class I SaMDs may have an impact on public health if they are not known and monitored by European competent authorities.<\/jats:p>","DOI":"10.3233\/shti220652","type":"book-chapter","created":{"date-parts":[[2022,6,30]],"date-time":"2022-06-30T07:32:06Z","timestamp":1656574326000},"source":"Crossref","is-referenced-by-count":1,"title":["Impact of Class I Software as Medical Devices (SaMDs) on Public Health"],"prefix":"10.3233","author":[{"given":"Marlon Luca","family":"Machal","sequence":"first","affiliation":[{"name":"Faculty of Medicine and Health Technology, Tampere University, Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"7437","container-title":["Studies in Health Technology and Informatics","Advances in Informatics, Management and Technology in Healthcare"],"original-title":[],"link":[{"URL":"https:\/\/ebooks.iospress.nl\/pdf\/doi\/10.3233\/SHTI220652","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,6,30]],"date-time":"2022-06-30T07:32:07Z","timestamp":1656574327000},"score":1,"resource":{"primary":{"URL":"https:\/\/ebooks.iospress.nl\/doi\/10.3233\/SHTI220652"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,6,29]]},"references-count":0,"URL":"https:\/\/doi.org\/10.3233\/shti220652","relation":{},"ISSN":["0926-9630","1879-8365"],"issn-type":[{"value":"0926-9630","type":"print"},{"value":"1879-8365","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,6,29]]}}}