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 (classified in four main categories according to the 2017/745 MDR): Authorised agents and new Medical Devices Regulation (MDR) The 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. You must appoint a legal representative within the EU to act on your behalf. Under section 11, all foreign producers must designate an “agent.” It could be a business or an individual. The task is primarily to act as your representative before the authorities. You must decide the scope and mandate of your agent (see section 11, 2). Article 14, paragraph 2 of the Medical Devices Directive; “If a manufacturer that puts a device into service under its own name does not have a head office in a Member State, it appoints a single agent in the European Union.” In both cases, the manufacturer must appoint a new agent within the EU to continue to sell products on the European market. 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. 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.