(ae) date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use, with a clear indication of the introduced modifications;
(ae) dáta eisiúna na dtreoracha úsáide nó, má rinneadh athcheartú orthu, an dáta eisiúna agus sainaitheantóir an athbhreithnithe is deireanaí, agus na modhnuithe a tugadh isteach á sonrú go soiléir;