Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
I gcás nach bhfuil monaróir feiste bunaithe i mBallstát, ní fhéadfar an fheiste a chur ar an margadh san Aontas ach i gcás ina n-ainmníonn an monaróir ionadaí údaraithe aonair.