In accordance with Article 12 of the EU MDR and eu IVDR, the terms 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 agent who arrives. The agreement should at least take into account the following aspects: the greatest risk a manufacturer takes when advancing the terms of the agreement 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. No, the agent`s name remains on devices that have already been sold and still in use, resulting in the continuation of certain obligations even after the termination of the contract. Confidentiality should be covered in the agreement between your company and the agent in accordance with the Medical Devices Directive, which stipulates that all ERs, including the authorities, are required to respect the confidentiality of all information provided and provided in the technical file. In accordance with the European Medical Devices Directive and the Medical Devices Regulation, a European agent must be appointed by a foreign manufacturer (European Community) of medical devices, medical devices for in vitro diagnostics. Each class of medical devices 3500 Euros / TWO UMDNS or GMDN product code. Additional Medical Devices 200 Euro /Product Codes First, select an authorized representative who is experienced and well experienced in the fields of medical devices and knowledge of technical files and design records. Then you draw up an agreement clearly specifying the essential functions of the agent, in accordance with the requirements of the Medical Devices Directive or the Medical Devices Regulation. We are regulatory consultants and European agent for medical devices and IVDs.
That`s why we understand your device better than any other professional working as representatives of the EAR, the EU or the EU. Our services are economical and faster. The design and signature take no more than 10 days. Both the EU representative and the manufacturer are required to terminate the infringement under conditions imposed by the Member State, such as letters of formal notice, sanctions, prohibition of sale, etc. In addition, the manufacturer puts its name on the device. This generic model contains the minimum requirements that must be written on an agreement between the manufacturer and the European authorized representative.