(i) "manufacturer " means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
i) tootja – füüsiline või juriidiline isik, kes on vastutav seadme kavandamise, valmistamise, pakendamise ja märgistamise eest enne selle oma nime all turule viimist, olenemata sellest, kas neid toiminguid teeb ta ise või kolmas isik tema nimel.