Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following:
Déanfaidh monaróirí feistí a chuirtear ar fáil ar mhargadh an Aontais, seachas feistí imscrúdaitheacha, na nithe seo a leanas a thuairisciú chuig na hudárais inniúla ábhartha tríd an gcóras leictreonach dá dtagraítear ini gcomhréir le hAirteagal 92(5) agus (7):