Before placing a device, other than a custom-made device, on the market, the manufacturer shall assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of the issuing entity designated by the Commission in accordance with paragraph 2.
Sula gcuirfear feiste ar an margadh, seachas feiste shaincheaptha, sannfaidh an monaróir SFU don fheiste agus, i gcás inarb infheidhme, do gach leibhéal ard pacáistithe, ar SFU é a chruthófar agus rialacha de chuid eintitis eisiúna noeintiiteas eisiúna a ainmneoidh an Coimisiún i gcomhréir le mír 2 á gcomhlíonadh.