an indication that the device is an in vitro diagnostic medical device, or if the device is a ‘device for performance study’, an indication of that fact;
ráiteas gur feiste leighis dhiagnóiseach in vitro í an fheiste leighis, nó i gcás inar “feiste le haghaidh staidéar ar fheidhmíocht” í, ráiteas gurb amhlaidh atá sí;