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. In both cases, the manufacturer must appoint a new agent within the EU to continue to sell products on the European market. What is the role of the agent at the MDR? Agents will assume more risks and responsibilities under the new European Medical Devices Regulation (MRM). The EC REP is jointly responsible for defective medical devices, so you can assume that your representative monitors your compliance more closely. Download our 28-page white paper to learn more about MDR changes. Your European plenipotentiary serves as a liaison between you and the relevant national authorities (ministries of health). In addition, your designated representative: how could Brexit affect the representation obligations of aircraft companies selling in the UK and the EU? Because of the new MDR and/or Brexit, do you have any further questions about RAs for medical devices or a policy change? Certification experts are ready to help. 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. The EU representative is subject to EU law. However, the device manufacturer is domiciled outside EU jurisdiction and may decide not to cooperate with EU authorities. In order to minimize the agent`s exposure to the fact that he goes to the beneficiary side of a manufacturer`s debts, the sanction clauses provide for an appeal. 14) Why do authorized representation agreements contain a sanction clause for violations by the manufacturer? 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: confidentiality should be covered by the agreement between your company and the agent in accordance with the Medical Devices Directive, which stipulates that all ERAs, including the authorities, are required to respect the confidentiality of all information provided and provided in the technical file. 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. 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.