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A European Authorized Representative (AER) in the context of the European Union (EU) plays a crucial role in ensuring that products placed on the EU market comply with relevant regulations. This role is particularly important for non-EU manufacturers who want to sell their products in the EU. Here are some of the key tasks and responsibilities of an Authorized Representative in the EU
European Authorized representative
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The European Authorized Representative must have a legal presence in the European Union, and their address should be specified on the product labeling.
The EAR acts as a liaison between the manufacturer (located outside the EU) and the competent authorities in the EU member states. They are responsible for communicating with the relevant authorities on behalf of the manufacturer.
The EAR is often involved in the registration and listing process of medical devices and in-vitro diagnostic devices. This may include submitting information to the European database on medical devices (EUDAMED).
Monitoring and reporting adverse events, complaints, and other post-market surveillance information to the competent authorities as required by EU regulations.
The EAR should have access to the technical documentation for the medical device or in-vitro diagnostic device. This documentation should be made available to competent authorities upon request.
The EAR must maintain records of their activities, including documentation related to product compliance, communication with authorities, and incident reports.
The EAR can provide valuable assistance to non-EU manufacturers in navigating the regulatory landscape, helping them understand and meet EU requirements.
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The EAR must cooperate with the competent authorities in any actions taken to eliminate or mitigate risks posed by devices they represent. This includes providing information requested by authorities in a timely manner.
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