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Product introduction: In order to improve the overall efficiency of market supervision, the European Commission requires all Member States to meet the minimum legal requirements. The European Commission cooperates with the customs and cooperates with relevant parties (manufacturers, EU authorized representatives, importers and distributors) to establish a perfect product traceability system. The European Commission first focuses on high-risk areas, such as medical devices.EU medical device directives: 93-42-eec, 98-79-ec and 90-385-ec cover all medical device products. These three directives require non EU manufacturers to have EU authorized representatives.EU authorized representative / EU representative (European authorized representative or European authorized representative) refers to a natural person or legal person expressly designated by manufacturers located outside the European Economic Area EEA (including EU and EFTA). The natural person or legal person can perform specific duties required by relevant EU directives and laws on behalf of manufacturers outside EEA.1. The new method Directive requires that the EU authorized representative / EU representative must be located in the European economic area and have a business registration address (some countries also require that the EU authorized representative / EU representative must have a company registration number or EU VAT registration number);The governments and competent authorities of EEA member states can directly go to the authorized representative of the EU / EU representative at any time to check whether the manufacturers outside EEA have fulfilled the responsibilities required by relevant EU directives and laws;The general business representative of the manufacturer (e.g. authorized dealer), whether located in the European economic area or not, should not be confused with the EU authorized representative / EU representative required by the new method directive;Although the EU authorized representative / EU representative can perform the specific responsibilities required for the manufacturer by the relevant EU directives and laws on behalf of the manufacturer outside EEA, the manufacturer is still the party bearing the main responsibility.Without the consent of the manufacturer, the EU authorized representative / EU representative may not independently change the products manufactured by manufacturers outside EEA, even in order to make the illegal products comply with the requirements of the EU product directive.Main services of EU authorized representative (EU authorized agent):Products with CE mark published on the website:1. Publish your products with CE mark on the website for third-party verification.2. As a professional and experienced EU authorized representative (EU authorized agent), the company can assist the manufacturer to negotiate with relevant EU departments at the first time. If your product is blocked by EU customs for the purpose of market supervision, as long as you print us as your EU authorized representative (EU authorized agent) AR on the package or attached documents of the product, EU customs will:3. Through network verification, contact our company to confirm that we are the EU authorized representative (EU authorized agent) AR of your products. Through our certificate, your products will be released.Products registered in EU:According to the relevant requirements of the EU, we register your products in the EU and obtain the 'product registration certificate'. The validity period of the product registration certificate is generally one year, which is updated every year. Meanwhile, as long as the product information changes, the product registration information must be updated in time.Save the 'technical documentation' of your product:We will keep and update the technical documents of your products sold in the EU, and ensure that they can be provided to the CE supervision authority in the EU for inspection at any time and in time as needed. After the last batch of products are put into the market, their technical documents shall be retained in the authorized representative office of the EU for at least 5 years.Tracking of laws and regulations:We will track and report the latest development of laws and regulations related to your products in the EU.Establish 'accident prevention and supervision system':Establish an 'accident prevention and supervision system' in the EU. Assist in product accident reporting, notification and recall.
Project introduction: In order to achieve product traceability, the products with CE mark put into the EU market by the manufacturer must be marked with the manufacturer's name and contact address; If the manufacturer is from a country other than EEA (including EU and EFTA), its products must be marked with the name and contact address of the manufacturer and the manufacturer's EU authorized representative / EU representative at the same time.
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EU representative
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  • Certification application

In order to improve the overall efficiency of market supervision, the European Commission requires all Member States to meet the minimum legal requirements. The European Commission cooperates with the customs and cooperates with relevant parties (manufacturers, EU authorized representatives, importers and distributors) to establish a perfect product traceability system. The European Commission first focuses on high-risk areas, such as medical devices.

EU medical device directives: 93-42-eec, 98-79-ec and 90-385-ec cover all medical device products. These three directives require non EU manufacturers to have EU authorized representatives.

EU authorized representative / EU representative (European authorized representative or European authorized representative) refers to a natural person or legal person expressly designated by manufacturers located outside the European Economic Area EEA (including EU and EFTA). The natural person or legal person can perform specific duties required by relevant EU directives and laws on behalf of manufacturers outside EEA.

1. The new method Directive requires that the EU authorized representative / EU representative must be located in the European economic area and have a business registration address (some countries also require that the EU authorized representative / EU representative must have a company registration number or EU VAT registration number);


The governments and competent authorities of EEA member states can directly go to the authorized representative of the EU / EU representative at any time to check whether the manufacturers outside EEA have fulfilled the responsibilities required by relevant EU directives and laws;

The general business representative of the manufacturer (e.g. authorized dealer), whether located in the European economic area or not, should not be confused with the EU authorized representative / EU representative required by the new method directive;

Although the EU authorized representative / EU representative can perform the specific responsibilities required for the manufacturer by the relevant EU directives and laws on behalf of the manufacturer outside EEA, the manufacturer is still the party bearing the main responsibility.

Without the consent of the manufacturer, the EU authorized representative / EU representative may not independently change the products manufactured by manufacturers outside EEA, even in order to make the illegal products comply with the requirements of the EU product directive.

Main services of EU authorized representative (EU authorized agent):


Products with CE mark published on the website:
1. Publish your products with CE mark on the website for third-party verification.

2. As a professional and experienced EU authorized representative (EU authorized agent), the company can assist the manufacturer to negotiate with relevant EU departments at the first time. If your product is blocked by EU customs for the purpose of market supervision, as long as you print us as your EU authorized representative (EU authorized agent) AR on the package or attached documents of the product, EU customs will:

3. Through network verification, contact our company to confirm that we are the EU authorized representative (EU authorized agent) AR of your products. Through our certificate, your products will be released.

Products registered in EU:
According to the relevant requirements of the EU, we register your products in the EU and obtain the 'product registration certificate'. The validity period of the product registration certificate is generally one year, which is updated every year. Meanwhile, as long as the product information changes, the product registration information must be updated in time.

Save the 'technical documentation' of your product:
We will keep and update the technical documents of your products sold in the EU, and ensure that they can be provided to the CE supervision authority in the EU for inspection at any time and in time as needed. After the last batch of products are put into the market, their technical documents shall be retained in the authorized representative office of the EU for at least 5 years.

Tracking of laws and regulations:
We will track and report the latest development of laws and regulations related to your products in the EU.

Establish 'accident prevention and supervision system':
Establish an 'accident prevention and supervision system' in the EU. Assist in product accident reporting, notification and recall.

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