C
The answer is in your own post. Your second bullet point states "information must be set out in the leaflet supplied with one or more devices.". It is the interpretation in Germany that leaflet means paper. The concern is that users will not be able to access an electronic IFU or will not make the effort to do so. There is concern that this will result in increased user error. There are already many reportable incidences caused by failure to follow or read the IFU.
It is worth noting that the 2007 revision of the MDD requires that guidance be developed on this topic. I have seen a draft of this guidance, but it is still not a finalized document. Once this becomes final, it will be feasible to have electronic IFUs, provided that the guidance is adhered to.
It is worth noting that the 2007 revision of the MDD requires that guidance be developed on this topic. I have seen a draft of this guidance, but it is still not a finalized document. Once this becomes final, it will be feasible to have electronic IFUs, provided that the guidance is adhered to.