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. 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. For this reason, it is desirable that all manufacturers be aware of all the responsibilities they require in such situations and that they use the services of a competent ERA to keep them informed of the appropriate procedures and procedures. While all of the rights mentioned above are applicable to the AER in accordance with directive 2001/95/EC, it is important to note that the real process of ensuring full compliance with the directive (and any other applicable EU directive) is entirely up to the manufacturer and that all sanctions or effects of non-compliance will also fall to the manufacturer. It is important to pay attention to this, as exceeding the limits of the builder-EAR relationship can have serious consequences. Since the introduction of the European Agent Obligation (EAR) for any manufacturer established outside the European Union that wishes to introduce products to the European market in accordance with the 2001/95/EC Directive on General Product Safety 2001/95/EC, many manufacturers have expressed concerns about the limits, limits and responsibilities of the relationship between the manufacturer and the EAR.

One of the most fundamental aspects that you should understand when working with a European agent to launch your products on the European market is what obligations should be imposed on them as a manufacturer and what information and documents should be provided and processed by your EAR. Understanding the basics in this way can help maintain responsibility for the good part and avoid unnecessary complications in the relationship that can be problematic on the line.