Software change not visible/activated to users


Involved In Discussions
Hello, we are thinking of adding a software feature to our SaMD, deployed in the US and Europe, which would be considered a significant change in Europe.
Therefore, we were thinking in "activating" this new feature only in the US and not in Europe until we transition to MDR (our admin can activate certain features for specific sites/geographies).

My question is, I think I know the answer but I need to hear it from someone else, if we modify the software to implement this new feature but this change is not visible to the EU users (in other words, this optional feature is not activated), should it be considered as a design change in the device's EU documentation ?
And once we obtain the MDR certification and we activate this feature for our EU users we add it to the EU documentation ?
I am not a developper but I feel this strategy is borderline as although is it is not visible to the users, this software change / code change may impact other "software items" which may impact in the end the user.
Thanks for your help !


Super Moderator
Historically, there's been a fear (with regulatory reviewers) that something may glitch and the user starts executing the code that shouldn't be reachable. The merits of that fear are debatable, I guess.

Probably the best way around it is to have 2 executable variants and use conditional compilation to exclude the features not for the EU (instead of disabling). There would be some extra baggage, like ensuring unique identification for each variant and ensuring the labeling (IFU) is correct for each variant.
Top Bottom