Abstract

The European Association of Authorised Representatives (EAAR) represents the interests of Authorised Representatives (ARs) and their clients. With the implementation of the new Medical Devices Regulations (MDR 2017/745; IVDR 2017/746 – from now on referred to as MDR/IVDR) the role and responsibilities of authorised representatives (AR) are now defined, and specific tasks have been identified. While the role has been clarified, the newly defined tasks will be further revealed as the experience level among ARs increases. A first guideline for ARs has been established to provide additional clarification for all stakeholders. Not all but several pertinent aspects will be discussed here. The EAAR has been created to offer input into the evolving role and responsibilities of ARs. It also represents the clients it serves, making the European Commission, authorities and other stakeholders aware of the challenges faced by manufacturers outside of the EU when complying with the regulations.