In order to improve the overall efficiency of market regulation, the European Commission requires all member states to meet the minimum legal requirements. The Commission cooperates with customs and cooperates with relevant parties (manufacturers, EU authorized representatives, importers, distributors) to establish a comprehensive product traceability system. The European Commission first focuses on high-risk areas, such as medical devices.
The EU's medical device directives: 93-42-EEC, 98-79-EC, and 90-385-EC cover all medical device products, all of which require non EU manufacturers to have an EU authorized representative.
EU Authorized Representative/EU Representative (European Authorized Representative or European Authorized Representative) refers to a natural or legal person specifically designated by a manufacturer located outside the European Economic Area (EEA) (including EU and EFTA). The natural or legal person may represent a manufacturer outside of EEA to fulfill specific duties required by EU directives and laws for the manufacturer.
1. The new method directive requires EU authorized representatives/EU representatives to be located within the European Economic Area and have a commercial registration address (some countries also require EU authorized representatives/EU representatives to have a company registration number or EU value-added tax VAT registration number);
The governments and competent authorities of EEA member states can directly contact the EU authorized representative/EU representative at any time to verify whether manufacturers outside of EEA have fulfilled the responsibilities required by EU relevant directives and laws;
The general business representative of the manufacturer (such as authorized distributor), whether located within 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 represent manufacturers outside of EEA to fulfill specific responsibilities required by EU directives and laws for the manufacturer, the manufacturer still bears the primary responsibility.
Without the consent of the manufacturer, EU authorized representatives/EU representatives are not allowed to independently modify products manufactured by manufacturers outside of EEA, even in order to make the offending products comply with the requirements of the EU Product Directive.
The main services of EU authorized representatives (EU authorized agents) include:
Products that have obtained the CE mark are announced on the website:
1. Publish your CE marked products on the website for third-party verification.
As a professional and senior EU authorized representative (EU authorized agent) company, we can assist manufacturers in negotiating with relevant EU departments as soon as possible. If your product is obstructed by EU customs for market supervision purposes, as long as you print our EU authorized representative (EU authorized agent) AR on the packaging or accompanying documents of the product, EU customs will:
3. Through online verification, contact our company to confirm that we are the EU authorized representative (EU authorized agent) AR for your product. Through our certification, your product will be released.
Product registered in the European Union:
According to the relevant requirements of the European Union, we register your product in the EU and obtain a 'Product Registration Certificate'. The validity period of the product registration certificate is generally one year, which is updated annually. During this period, whenever there is a change in product information, it is necessary to update the product registration information in a timely manner.
Save the 'technical files' of your product:
We will save and update the technical documents of the products you sell within the EU, and ensure that they can be provided to the CE regulatory authorities within the EU for inspection at any time and in a timely manner as needed. After the last batch of products is put into the market, their technical documents should be retained at the authorized representative office of the European Union for at least 5 years.
Tracking in terms of laws and regulations:
We will track and report on the latest developments in laws and regulations related to your products within the EU.
Establish an 'accident prevention and supervision system':
Establish an 'accident prevention and supervision system' within the EU. Provide assistance in product accident reporting, notification, and recall.