the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;
soláthraíonn an institiúid sláinte faisnéis dá húdarás inniúil, arna iarraidh sin, maidir le húsáid feistí den sórt sin, ar faisnéis í ar a n-áireofar dlisteanú dá monarú, dá modhnú agus dá n-úsáid;