Impact of Class I Software as Medical Devices (SaMDs) on Public Health

Abstract

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.