SaMD : Is the frontend part of the medicla device under EU MDR ?

Anonymous · Published December 11, 2025

In a CE-marked SaMD under EU MDR, only the backend of our software performs the medical function (clinical data processing, rule evaluation, alert generation).

The frontend performs no medical logic and only displays the output from the backend.

According to MDCG 2019-11, should this frontend be considered part of the medical device software, or is it treated as a non-medical host interface?

In practical terms: must the frontend be included in the IEC 62304 scope and verified as part of the MDSW?
Or is usability engineering under IEC 62366 sufficient as long as the frontend does not perform any medical function?

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