Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient.
Áiritheoidh monaróirí go mbeidh an fhaisnéis a leagtar amach i Roinn 23 d'Iarscríbhinn I ag gabháil leis an bhfeiste i dteanga oifigiúil nó i dteangacha oifigiúla de chuid an Aontais a chinnfidh an Ballstát ina gcuirfear an fheiste ar fáil don úsáideoir nó don othar.