If a device such as a game console (Wii, Play Station or Nintendo Switch) is to be used as part of a therapy with children. The goal of the research is to find out if such a device can be used to motivate children to do physical therapy and what is the effect of exercising with this type of technology. Would this be considered a research medical device if not, then what?
The use is not what the manufactured intended the device. Is this considered a off-label CE marking? Should the manufacturer be somehow involved in the research?