Impact of Class I Software as Medical Devices (SaMDs) on Public Health
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 SaM...
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| Format: | Article |
| Language: | English |
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NLM (Medline)
2022
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| Online Access: | View Fulltext in Publisher |