✿ Manufacturers outside the EU/EAA must have an authorised representative within the EU/EEA in order for devices to be placed on the market within the EU/EEA. The authorised representative’s responsibility must be regulated in a mandate from the manufacturer. An authorised representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the Regulations. Responsibilities include but not limited to:
✿ The authorised representative must be a point of contact for authorities and users within the EU/EEA for the devices in question
✿ The authorised representative has the legal responsibility for defective devices on an equal basis with the manufacturer