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Module 'Onderzoek met medische hulpmiddelen'

Foto van Tamara Pinos Cisneros
Re: Module 'Onderzoek met medische hulpmiddelen'
door Tamara Pinos Cisneros - zondag, 27 september 2020, 15:43

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?