A European authorised representative (AR) represents a non-EU manufacturer and acts on their behalf in relation to specific compliance tasks. These tasks are specified in the written mandate signed between the authorised representative and the manufacturer. They may differ, depending on the requirements of the EU directives that apply to the product covered in the mandate.
Generally, the mandate must allow the authorised representative to perform at least the following tasks:
- Keep the technical file and EU declaration of conformity of the product at the disposal of national market surveillance authorities for ten years (in some cases – five years)
- Provide the national market surveillance authorities with all the documentation required to demonstrate the CE marking conformity of the product.
- Cooperate with the national market surveillance authorities on preventive and corrective actions to eliminate any risks posed by the product.
- Upon request, deliver a copy of the written mandate to the national market surveillance authorities.
The authorised representative is not responsible for certifying the product covered in the mandate received from the non-European manufacturer. The AR's obligations do not include drawing up technical documentation or ensuring the safe design and manufacture of the product either. However, the AR may be responsible for reviewing the technical documentation and evaluating the conformity procedures and safety of the product if specified in the written mandate.