1. Verification of Regulatory Compliance

The EU AR must verify that the manufacturer has prepared the required EU Declaration of Conformity and technical documentation and, where applicable, that the appropriate conformity assessment procedure has been completed. The AR therefore needs sufficient regulatory oversight to determine whether the manufacturer's regulatory framework is in place.

Importantly, the EU AR does not take over the manufacturer's fundamental responsibilities. The manufacturer remains responsible for the design, manufacture, quality management system and the preparation of the technical documentation. These responsibilities cannot simply be transferred to the AR.

2. Maintaining Regulatory Documentation

The EU AR must keep copies of the relevant regulatory documentation available for competent authorities when required. This includes documentation such as the technical documentation, EU Declaration of Conformity and relevant certificates, depending on the applicable conformity assessment route.

This ensures that European authorities have an established regulatory contact point and can obtain the necessary information when exercising their market-surveillance responsibilities.

3. Point of Contact for Competent Authorities

One of the most important functions of the EU AR is to act as the manufacturer's formal point of contact with EU competent authorities.

For a manufacturer located in Asia, North America or another non-EU jurisdiction, the AR provides a legally established European interface for regulatory communication. Authorities can therefore communicate with the manufacturer through its EU-based representative when required.

4. EUDAMED and Device Registration

The EU AR plays an important role in ensuring that the manufacturer's registration obligations are properly addressed within EUDAMED, the European Database on Medical Devices.

The AR has verification responsibilities concerning the manufacturer's UDI and device-registration obligations. For non-EU manufacturers, an active EU AR is also required for the relevant EUDAMED actor-registration process.

The manufacturer itself remains responsible for its registration obligations; these cannot simply be transferred to the AR. The AR provides the regulatory representation and verifies the applicable requirements.

5. Post-Market Surveillance, Complaints and Vigilance

EU Authorized Representation continues after CE marking and market placement.

The AR must cooperate with the manufacturer regarding complaints, suspected incidents and safety-related information and support the appropriate communication with competent authorities. This is particularly important because the MDR follows a lifecycle approach, meaning regulatory compliance continues throughout the period in which the device is available on the market.

An effective AR should therefore have a clear process for receiving regulatory information, escalating safety issues and coordinating the required actions with the manufacturer.

6. Preventive and Corrective Actions

Where a potential safety or compliance problem is identified, the EU AR may be involved in coordinating communication and regulatory actions.

Depending on the circumstances, this can include supporting corrective actions, preventive actions, field safety corrective actions, recalls or other measures and communicating with the relevant competent authorities.

The AR's role becomes particularly important when the manufacturer needs to respond quickly to a regulatory or safety issue within the EU market.

7. Cooperation with Competent Authorities and Product Testing

Competent authorities may request information, documentation, samples or access to devices as part of market surveillance. The EU AR has an obligation to cooperate with authorities and facilitate the manufacturer's response where applicable.

This means that the AR must be more than a company name and address on the product label. It needs to maintain the organisational capability to respond to regulatory requests and support market-surveillance activities.

The AR is part of your own Regulatory Infrastructure 

The most important point for non-EU manufacturers is that an EU Authorized Representative should be viewed as a long-term regulatory partner, not simply as a mandatory address in Europe.

The relationship continues throughout the device lifecycle: from registration and market entry through post-market surveillance, vigilance and potential regulatory actions.

At FENARIS, we provide EU Authorized Representation together with broader MDR regulatory support, allowing manufacturers to maintain a single, experienced European regulatory interface while retaining full control and responsibility for their products.

For manufacturers outside the EU, the right Authorized Representative can make European market access significantly more structured, transparent and manageable.