One consequence of this is that such agreements can often make it difficult for a producer to establish a relationship with a new ITA. This may have the effect of excluding producers from the European market or of being open to any other combination of avoidable consequences. Therefore, all manufacturers are advised to be aware of all the responsibilities required of them in such situations and to use the services of a competent ITA that can keep them informed of the appropriate processes and procedures. If you are a medical device manufacturer established outside Europe, you must appoint an authorised representative and an importer to market your products on the EU market. This agreement will help you define the right requirements to comply with the regulation. The biggest risk a manufacturer takes by advancing the terms of the agreement with an AEOI in terms of liability and liability is the eventual termination of the agreement. As planned in 2001/95/EC, a manufacturer established outside Europe may not market products on the European market without a representative established in the European Community. As a result, products deemed non-compliant may face withdrawal from the market or even a total ban. While all of the above obligations are covered by the AER under Directive 2001/95/EC, it is important to keep in mind that the process itself, in order to ensure that all products are fully compliant with the Directive (and any other applicable EU Directive), is entirely the responsibility of the manufacturer and that any sanctions or effects of non-compliance are also within the competence of the manufacturer. It is important to keep this in mind, as shifting the boundaries of the manufacturer-EAR relationship can have serious consequences. This European plenipotentiary agreement is necessary for medical device manufacturers established outside the EU who wish to place a medical device on the EU market. To understand which of the parties` obligations are, it is first important to understand the function of the agent.
GPSD 2001/95/EC, introduced on 15 January 2004, established the legal obligation for any manufacturer established outside the European Union to use the services of an authorised representative in order to satisfy its interests within the European Union. The aim is to enhance consumer safety and increase transparency and harmonisation in the EU market. Since the introduction of the mandatory requirement of a European Authorised Representative (AEOI) for any manufacturer established outside the European Union who wishes to place products on the European market in accordance with Directive 2001/95/EC on general product safety, many manufacturers have expressed concerns about the accepted limit values, limits and responsibilities in the relationship between the manufacturer and the EAR. One of the most fundamental aspects you should understand when working with a European authorised representative to bring your products to the European market is what your obligations are as a manufacturer and what information and documentation should be provided to your AEOI and processed by it. . . .