Hi, it also depends on the user, i.e., if the software is going to be used directly by the patient or, for example, by a qualified doctor.
Back in 2009 I looked through the individual transposition of the MMD as a national law in France and Germany.
In the case of France the requirement of translation is for medical devices to be used by the patient, there is no specification about professional use (see
Articles R5211-12 à R5211-20 (French version)
Full context of French MDD can be found
here (in French).
In the case of Germany, they do specify the following, quoted from the attached “German Medical Devices Act.pdf”. Part II, §11 (2):
“Medical devices may only be supplied to users if the information destined for their use is written in the German language. In justified cases, another language which is easily understood by the user of a medical device can be envisaged or provisions can be made to ensure that the user is informed by other means. However, in such a case, the information bearing on safety must be present in German or in the language of the user.”
The german act in German can be found
here.
I have no information about Switzerland, I am afraid.
Also attached a document from the European Union (dated 2005). Please, let us know the result of your investigation.