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. If you are a processing manager outside the EU, but you offer goods or services (even free of charge) to EU users or monitor their behaviour as it occurs in the EU, you must appoint an EU representative based in one of the EU countries where your users are based. 13) Is product liability covered by the agent`s agreement? You must now appoint a representative who will be your company`s main interlocutor in the EU. An important part of this process, defined by the RGPD itself, is to create a „written mandate.“ 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. Harmful clauses are often part of independent agreements or partnerships. They are also common in general conditions and guidelines for authorized use. As the author of this agreement with your EU representative, you can insert a clause stipulating where disputes are heard. „The representative cannot enter into agreements on behalf of the company. Except in the context of their role as representative of the Union (as defined above), the delegate cannot make a statement on behalf of the company without prior authorization. The greatest risk a manufacturer takes when it speeds up contractual terms 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.
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. A confidentiality clause or a „non-disclosure agreement“ (NDA) legally obliges your EU representative not to disclose confidential information to unauthorized parties. 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. One of these effects is that agreements that are so terminated can often make it more difficult for a manufacturer to establish a relationship with a new EAR. This may result in the exclusion of producers from the European market or the opening up to any other combination of avoidable consequences.