Before placing a device, other than a custom-made device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
Sula gcuirfear feiste ar an margadh, seachas feiste shaincheaptha, déanfaidh an monaróir, i gcomhréir le rialacha an eintitis eisiúna dá dtagraítear in Airteagal 27(2), SF-SFU a shainmhínítear i gCuid C d'Iarscríbhinn VI a shannadh don fheiste agus soláthróidh sé do bhunachar sonraí SFU é mar aon le buneilimintí sonraí eile dá dtagraítear i gCuid B d'Iarscríbhinn VI a bhaineann leis an bhfeiste sin.