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What is the role of the EU authorized representative?

According to the EU market surveillance regulations that will be implemented on July 16, 2021, if products with the CE marking want to enter the EU market for sale, the CE-marked products need to have an EU responsible person as a point of contact for compliance. If a product outside the EU lacks information from an EU authorized representative and enters the market for sale hastily, it will face a strict audit by the EU market supervision authorities.

What is the role of the EU authorized representative?

1. In accordance with the requirements of EU regulations, when applying for CE certification, a non-Eu seller must have an EU representative agreement to apply for CE.

2. In accordance with EU regulations, after obtaining CE certification, the product package must be marked with the CE logo and the company name and address of EU representative. In this case, CE means that the product has passed the safety certification, and EU representative is traceable. In case of any question from customers, customs, or any EU competent authority, one can directly contact the EU representative. EU representative can communicate and deal with it, which can play a role in efficient communication and ensure traceability.

3. When enterprises apply for CE certification, according to the requirements of the directive, these products must make a complete set of technical documents, which cover risk analysis and basic requirements inspection.

4. The packaging, label and instruction manual of the products imported from outside the EU and affixed with the CE mark must be clearly printed with the name and address of the manufacturer’s EU authorized representative.

5. The “technical files” must be kept by the EU authorized representative. The EU authorized representative must save the latest technical files of all products with the CE mark. According to EU regulation, they can be provided to the supervisory authority in the EU for inspection at any time and in a timely manner. After the last batch of products are put on the market, their technical documents should be kept at the EU authorized representative for at least 5 years;

6. Establish an “accident prevention and supervision system”. Manufacturers outside the EU must establish an effective “accident prevention and supervision system” within the EU, and report accidents to products through their EU authorized representatives. The EU authorized representative provide assistance on announcement, recall, etc.

7. The EU authorized representative can also apply for device registration by the EU competent authority upon the manufacturer’s entrustment.

8. The EU authorized representative can also apply for a free sale certificate for the manufacturer upon the entrustment of the manufacturer.

Who should sign the DoC to be valid?

The significance of the DoC (Declaration of Conformity) is to declare that the manufacturer or brand owner is fully responsible for the compliance of its products with the EU’s compliance provisions and is a self-declaration document. Even if the EU representative pays joint and several liability for the products delivered by the manufacturer, he is not the owner of the product or the brand owner.  This declaration of conformity is the sole responsibility of the manufacturer.

According to the EU product compliance regulations, a “manufacturer” is a person who has the right to draft a DoC compliance statement, and the so-called “manufacturer” generally refers to the manufacturer or brand owner.

How to choose a qualified EU authorized representative?

1) Choose a qualified and capable professional third-party company with experienced personal in the EU who are familiar with EU regulations and can help manufacturers resolve disputes.

2) A valid EU authorized representative agreement or contract must be signed. The names and addresses of both parties of the contract/agreement must be the same as the names and addresses of the manufacturer and the EU authorized representative on the packaging/label of the product to be affixed with the CE mark in the future.

Have more questions? Contact us for free consulting in regards to the EU authorized representative for your product compliance journey in Europe!