One of these effects is that agreements that are so terminated 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 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. You can take the following steps on behalf of the manufacturer: If you are a manufacturer of medical devices outside Europe, you must appoint an agent and importer to place your devices on the EU market. This agreement will help you define the appropriate requirements to comply with the regulations. The greatest risk a manufacturer takes when it speeds up contractual terms with an EAR in terms of liability and liability is the eventual termination of the contract. As dictated in 2001/95/EC, a manufacturer headquartered outside Europe cannot place products on the European market without a well-established representative in the European Community.
As a result, products that do not comply in this way may face market withdrawals or even a total ban. 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 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.