Adding to what has been said by respected members above, the requirements of EU are covered in
BS EN 1041:2008+A1:2013 , and that of FDA in
21 CFR 807.87 (e) . Now the interpretation of these are very simple (please read N52 also, for a bit more clarity, with focus on Fig 1; the definitions 3.9; 3.10; 3.15; 3.17; 3.19; 3.20). Any information that hints at these requirements or lets say which the EU or FDA may leverage w.r.t to these points are the requirements.
What it means is, the manufacturer has to carefully analyze what you are displaying to the users or patient. For a SaMD it could be as simple as an advisory statement on the homepage (if a web application) or the default message printed on the generated reports, to as complicated as a specific way of configuration/ remedy, the information about which is provided on an User Manual. Thats it... not complicated at all but as tricky as it can get