Why do I need an attorney? Manufacturers of medical devices established outside the EU must have an agent in order to sell their products in the European Union. This is the case for manufacturers of all medical devices (divided into four main categories according to mDR 2017/745): one of the knock-on effects is that the agreements thus concluded can often make it more difficult for a manufacturer to establish a relationship with a new EAR. This may result in the exclusion of producers from the European market or the opening up to any other combination of avoidable consequences. For this reason, it is desirable that all manufacturers be aware of all the responsibilities they require in such situations and that they use the services of a competent ERA to keep them informed of the appropriate procedures and procedures. What is an agent? A European agent (also known as a ER or EC REP) is a legal entity acting as a liaison between a manufacturer outside the EU and a competent national authority (Ministry of Health) within the EU. The agent acts on behalf of the manufacturer within the UNION. They ensure that products sold on the EU market comply with EU directives. Since agents and manufacturers are jointly responsible if documentation does not comply with European compliance standards, it is of the utmost importance that an AR have a thorough understanding of guidelines, standards and more. In both cases, the manufacturer must appoint a new agent within the EU to continue to sell products on the European market. The Regulation (MDR) applicable to licensed agents and the new Medical Devices Regulation (MDR) 2017/745 will be fully implemented from 26 May 2020. The responsibilities of agents and manufacturers will be changed as technical documents will have to meet the requirements of the new regulations. To learn more about how to prepare your file for the new Medical Devices Regulation, click here.
What does an agent do? An agent verifies that products sold on the EU market comply with established European safety requirements. An AR does not certify the products, but they check the documents provided by the manufacturer and evaluate the certification procedures and product safety.