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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. 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. 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. 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. First, choose an experienced and experienced agent in the fields of medical devices and knowledge in 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. 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: acting on behalf of the manufacturer with respect to certain tasks related to their obligations under the EU MDR/IVDR. You must also name an importer.

Contact us if you need us to help you in your project to sell your products in Europe. 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. Step 2- After signing the contract, the manufacturer provides the necessary documents in accordance with a EUROPECERT checklist. The above fees are for ONE COUNTRY Betestitation. In addition, 1000 euros per country. A European plenipotentiary (representative of the EC, representative of the EC) acts as a legal entity of producers outside the European Community and fulfils the obligations of the manufacturer under the relevant European directives. 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.

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. Why do I need an agent in Europe? MedNet EC-REP is your competent regulatory partner for the successful marketing of your medical devices in Europe. If you look at our services to apply for an over-the-counter certificate, your company must name EUROPECERT your authorized European representative (EAR). All requirements required to meet the EU MDR 2017/745 and EU IVDR 2017/746 requirements have been verified and integrated. A reference to ISO 13485:2016 is also available. Procedure after the appointment of MedNet EC-REP as EU representative is known by several names, such as Z. E.A.R, EC Rep, EU Rep, Authorized Representative, CE Representative.

Posted on December 12th, 2020 | filed under Uncategorized |

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