With regard to the designation of an E.A.R., an agreement is signed between the manufacturer and the E. A.R., which basics indicates. In addition to the agreement, there is also mention of the rights and obligations of each party and the general nature of cooperation. E. A.R is shown on the label of medical devices with a logo, as shown below. The EU representative is compulsory for non-European manufacturers who wish to sell the medical device and in vitro diagnostic devices (IVD) on the European market. Each class of medical devices 3500 Euros / TWO UMDNS or GMDN product code. Additional medical devices 200 euro / product codes EC certification only allows entry into the European market and not to other global markets such as the Middle East and African countries. Due to the high standards and popularity of CE-certified medical devices, third countries require a free sales certificate from the manufacturer to show that the medical device meets the requirements of the MDDs. At the direct request of the industry, Eudamed.eu who use their extensive MDR and EUDAMED experience, table templates have been developed specifically for you, the agent. These models will help you fulfill your many legal obligations.

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. The EU representative plays a key role in bringing medical devices/IVD manufactured by manufacturers who are not established in the EU into compliance and as an ESTABLISHed interlocutor in the EU in compliance. CE marking of medical devices after Brexit The UK is no longer part of the EU. The following manufacturers must make adjustments in order to continue to sell their medical devices in the EU: in both cases, the manufacturer must appoint a new agent within the EU to continue to sell products on the European market. How do I choose an agent? The election of an agent is an extremely important part of the process. Because the AR will have access to all files and product information, manufacturers often do not want to designate an importer or distributor as an agent. The appointment of a party that has no economic or commercial relationship with the products (for example. B certification experts) is therefore an advantageous choice for manufacturers. 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. 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 measures on behalf of the manufacturer: in accordance with Article 12 of the EU MDR and the EU IVDR, the terms and conditions of a change of E. A.R should be clearly defined in an agreement between the manufacturer, to the extent that this is feasible, the outgoing agent and the new agent.