It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of an in vitro diagnostic medical device, qualifies as an in vitro diagnostic medical device, while software for general purposes, even when used in a healthcare setting, or software intended for well-being purposes is not an in vitro diagnostic medical device.
Is gá a shoiléiriú go gcáilítear bogearraí ina gceart féin mar fheiste leighis dhiagnóiseach in vitro, nuair a bheartaíonn an monaróir go sonrach iad lena n-úsáid le haghaidh críoch leighis amháin nó níos mó a leagtar amach sa sainmhíniú ar fheiste leighis dhiagnóiseach in vitro, agus nach feiste leighis dhiagnóiseach in vitro iad bogearraí a bhfuil críocha ginearálta leo, fiú nuair a bhaintear úsáid astu i dtimpeallacht cúraim sláinte, ná bogearraí a beartaíodh lena n-úsáid chun críoch leasa.