Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned.
Soláthróidh monaróirí, arna iarraidh sin d'údarás inniúil, an fhaisnéis agus an doiciméadacht uile is gá chun comhréireacht na feiste a thaispeáint, i dteanga oifigiúil de chuid an Aontais a chinnfidh an Ballstát lena mbaineann.