Authorized Representative

Engaging Instrux as an Authorized Representative means you can count on reliable regulatory compliance, efficient market access and cost-effective solutions, while focusing on the growth and development of your business.

What is an authorized representative?

An Authorized Representative (AR) is a legal or natural person, based within the European Union, who has received a written mandate from a manufacturer to act on their behalf for specific tasks under the applicable regulations. This is especially important for non-EU manufacturers who do not have an establishment within the EU. An AR acts as an interface between the manufacturer and national authorities, taking over responsibilities from the manufacturer and ensuring that products sold on the European market meet relevant compliance requirements.

For example, the AR checks whether a product may bear the CE mark by reviewing the product’s technical documentation. A competent AR can also answer questions from authorities and provide you, the manufacturer, with advice to avoid compliance problems.

At Instrux, we offer a comprehensive range of services as your Authorized Representative:

Analysis: We analyze your declaration of conformity and technical file.

Storage of documentation: We store all relevant compliance documentation for a period of 10 years.

Contact for Authorities: We act as the primary point of contact for EU authorities, allowing you to focus on your core business.

Use of our data: We consent to the use of our name and address so that you can sell in the EU.

 

Access within 24 hours from €1500 per year

What are the benefits of being an Authorized Representative?

Although the EU Market Surveillance Regulation (MSR) indicates that a European Economic Operator can also be an importer or Fulfilment Service Provider, appointing an EU Authorized Representative (AR) can still be very important. In fact, many Fulfilment Service Providers or distributors require you to appoint an AR. This is because if no other economic operator is appointed, they can be held responsible for potential risks under MSR regulations.

In addition, an AR ensures that importers do not have access to the manufacturer’s complete technical documentation. This includes, for example, specifications, CE test reports, operating instructions, design documents and the Declaration of Conformity (CE certificate). Thus, appointing an AR protects your confidential information and provides an extra layer of security.

It is also wise to choose an AR who is independent of commercial interests related to your product. Given an AR’s responsibility to verify the Declaration of Conformity and liaise with market regulators, it is essential that your AR is knowledgeable about compliance. An experienced and knowledgeable AR helps avoid legal complications and ensures that you, the manufacturer, are only informed of issues that directly affect the compliance of your product.

How does Instrux become your AR?

When you choose to engage with Instrux as your Authorized Representative, we immediately start collecting the necessary technical documentation and declarations of conformity, or declarations of performance. Based on this, we perform a quick documentation review so that we can offer an agreement within 24 hours. After signing, you will receive an official certificate in which we appoint ourselves as your Authorized Representative.

With the issuance of this certificate, all mentioned tasks are transferred to Instrux. From then on, we take over responsibility for these compliance obligations, so you no longer have to worry about them.

We are at your service within 24 hours.

Instrux is your reliable partner in a world of complex regulations. We take full responsibility for managing your documentation and liaising with authorities to ensure that your products always comply with applicable requirements. Our expert team is at your service within 24 hours, so you can concentrate on your core business and enter the market with confidence.

Appoint Instrux as your Authorized Representative (AR)