Since authorised representatives and manufacturers are jointly and severally liable if the documentation does not comply with European conformity standards, it is of the utmost importance that a RA has a thorough understanding of the relevant directives, standards and more. It is possible to appoint a distributor as an authorized representative in Europe; However, it is not recommended as most distributors are not willing to fulfill the mandatory responsibilities of the EPR EC. Instead, choose an independent representative who will focus on regulatory issues and not distribution and marketing. Learn more about the benefits of hiring an independent company acting as your EC REP in Europe. Why do I need a proxy? Medical device manufacturers established outside the EU must have an authorised representative in order to sell their products within the European Union.