EU Authorised Representative
What is an EU Authorised Representative?
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.
The Regulations also describe the tasks that can be delegated by the manufacturer to the Authorised Representative, and the conditions under which this can take place. This relationship should be covered by a precise mandate.
Who must appoint an EU Authorised Representative?
A manufacturer outside of the European Union and without a presence or an address in the EU and selling products to EU costumers must appoint an EU Authorised Representative.
What are the roles and responsibilities of an EU Authorised Representative?
The EU-AR has to perform the tasks specified in the written mandate received from the manufacturer. In general, the EU Authorised Representative has an obligation to do at least the following tasks in relation to a product:
• that an appropriate conformity assessment procedure has been carried out by the manufacturer
• verifying that the EU Declaration of Conformity (“DoC”) and technical documentation have been drawn up by the manufacturer. (An EU-AR is able to support the manufacturer to draw up a DoC on the manufacturer’s behalf.)
• EU-AR provide their European name and address which have to be placed by the manufacturer on the product, its packaging or accompanying documentation
• manufacturer has registered the requested information in EUDAMED
• keep copies available of all documents and make them accessible to authorities on request, includes technical documentation, DoC and certificates, including their amendments and supplements
• be keep informed of any changes in legal regulations and should inform the manufacturer of the changes well in advance
• cooperate with authorities on preventive and corrective actions, and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices.
• be liable for defective devices together with the manufacturer, if the manufacturer has not complied with its obligations under the Regulations and is not located in the EU