What is a European Authorized Representative (EU-AOR)? EU-AOR Evaluation

background

On September 23, 2011, the German Bundestag promulgated a revised version of the Equipment and Product Safety Act (GPSG), which is now the Product Safety Act (ProdSG), which clarifies the role of the EU representative. In order to ensure that all requirements of the CE Marking are met, EU law also requires manufacturers outside the EU to designate an EU authorized representative within the EU. This EU authorized representative is only a representative for product safety, and is neither an importer, nor an agent or sales representative. It should also be noted that as long as your product needs to be CE marked, you must find such an EU authorized representative.

Usage of Chinese translation

Since Chinese is not an official language of the EU, there is no corresponding official term in Chinese for European Authorised Representative. In Chinese translation, European Authorised Representative or European Authorized Representative is usually translated as: EU Authorized Representative. It can also be translated as: EU Authorized Agent, European Authorized Representative, European Authorized Agent, etc. It is usually abbreviated as: EU Representative or European Representative. It can also be used as: EU Agent, European Representative, European Agent, etc. In Taiwan, European Authorised Representative or European Representative is also used, although the European Community (EC-European Community) was replaced by the European Union (EU-European Union) as early as 1993.

Main Roles of EU Authorized Representative

In order to better protect EU consumers and the environment, EU law requires that, in order to achieve product traceability, products affixed with the CE mark and placed on the EU market by manufacturers must be marked with the manufacturer's name and contact address; if the manufacturer is from a country outside the European Economic Area (EEA) (including the EU and EFTA), its products must be marked with the name and contact address of both the manufacturer and the manufacturer's EU authorized representative.

Responsibilities of EU Authorized Representative

1. As the authorized representative designated by the manufacturer, he is responsible for contacting the medical device regulatory agencies of various countries within the EU to handle accidents, complaints, adverse events and recalls of medical devices;

2. Keep the manufacturer's CE technical documents and contact, respond and communicate with the manufacturer when the regulatory agency raises questions;

3. Register medical device products in the EU on behalf of the manufacturer;

4. Under the manufacturer's authorization, apply for a free sales certificate issued by the European Union.

Who can serve as the head of the European Representative?

1. Manufacturer (if established in the EU). Importer established in the EU.

2. An authorized representative established in the EU, designated as the responsible person in writing by the manufacturer or brand.

3. Delivery service providers established in the European Union.

How to choose a high-quality EU authorized representative?

1. Choose a qualified and capable professional third-party EU authorized representative company.

A legal company registered in the EU/with professional technical personnel, familiar with EU regulations, able to help manufacturers resolve disputes/avoid shell companies, agents and exhibition service providers. ------The above points can be confirmed by checking its EU registration certificate, calling its EU phone number to see if it is a recorded call, etc.

2. Sign a valid EU authorized representative agreement or contract.

The names and addresses of both parties in the contract/agreement must be exactly the same as the name and address of the manufacturer and the EU authorized representative on the packaging/label of the product to which the CE mark will be affixed.

3. The following matters should be noted:

The EU Authorized Representative Contractual Terms should be in the main official language of the EU.

Avoid EU Authorized Representatives that do not have a fixed office location and fixed contact number within the EU.

Avoid having distributors concurrently serve as EU Authorized Representatives.

Avoid having relatives or friends who are studying in Europe also serve as EU Authorized Representatives.

Documents required to apply for EU agency

1. EU Representative Application Form;

2. Product/brand related information: product list, product information (including product pictures), product samples, product manuals, CE certification and other valid certificates, product test reports, business license, etc.;

3. All UEFA products must have a packaging law registration number and a WEEE registration number.

Cross-border sellers

The name and address of the manufacturer's EU Authorized Representative/EU Representative (EU Importer) (EC-Representative) must be clearly printed on the packaging, labels and instruction manual of products affixed with the CE mark imported from outside the EU.

If you sell branded products from a certain company on Amazon Europe, the EU will consider you as the manufacturer of the product in the EU. Before you officially start selling products, it is your responsibility to confirm:

1. Whether the product has relevant compliance marks, such as the CE safety certification mark ;

2. The product appears to have relevant documentation, such as declaration of conformity, product instructions and safety information.

3. Whether the product has the name of the manufacturer and importer, their registered trade name or trademark, product type, batch number or serial number, and contact address. Sometimes, due to the size or material of the product, the manufacturer cannot include the above information on the product. In this case, the information can be displayed on the product packaging or product instructions;

4. As a brand product manufacturer, you should also ensure that the product is accompanied by a declaration of conformity. When selling products on Amazon, you can upload this document if necessary during the pre-approval process.

Please note that if you need to sign the declaration, assuming the product is produced in China, the declaration signed by the Chinese manufacturer is not accepted. The declaration must be issued by the EU importer to pass the review!