This generic model contains the minimum requirements that must be written on an agreement between the manufacturer and the European authorized representative. In this model, certain elements are highlighted, so you close them. There are also a few sections marked in blue that will lead you to what are a few items you can mention. 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. This agreement on the European agent is necessary for medical device manufacturers based outside the EU who wish to introduce a medical device to the EU market in Umden. You must also name an importer. Contact us if you need us to help you in your project to sell your products in Europe. All requirements required to meet the EU MDR 2017/745 and the EU IVDR 2017/746 have been verified and included. A reference to ISO 13485:2016 is also provided.