Article 12 15.

In the cases referred to in points 2(b), 4, 5(c), 7(b), (c) and (d), 8(b) to (e), 9(b) to (f), 11(c), 16, 17(a), (b) and (c), and 19(a) and (b) of Annex IV, the product or equipment shall be labelled with an indication that it shall be used only where required by the safety requirements or national safety standards, as applicable. Those requirements or standards shall be specified on the label. In the cases referred to in points 19 and 21 of Annex IV, the product or equipment shall be labelled with an indication that the product or equipment is to be used only where required by the medical application specified on the label.