European Authorized Representative

Background knowledge

In order to better protect the European consumers and environments, realize the products traceability, the legal of EU requires the products going into the EU market by manufacturers with the CE mark that marking with the name and contact address of manufacturer; If a manufacturer from the EEA (including EU and EFTA) outside the country, its product must also be marked name and contact addresses of manufacturers and the European authorized representative.

The European commission in order to enhance the overall market regulation efficiency, request all member states shall meet the minimum legal requirements, the European commission and customs co-operation, and cooperates with related party (manufacturer, European authorized representative, importers, distributors), establish perfect product traceability system. The European commission focus on risk areas first, such as: medical device.

The directive: 93-42-EEC, 98-79-EC, 90-385-EC covers all types of medical devices products, these three directives all required that non-EU manufacturers must have the European authorized representative.

Definition of European Authorized Representative

European Authorised Representative or European Authorized Representative refers to a company specifically designated by overseas manufacturers outside the EEA (including EU and EFTA). The company can represent EEA overseas manufacturers to perform specific duties that EU related directives and laws required the manufacturer.

The new method instruction require European authorized representative must be located within the EEA and have business registration address (some countries require European authorized representative that must have company registration number or the EU VAT registration number) ；

Government and competent authority of members of the EEA can find the European authorized representative directly at any time to check whether outside manufacturer fulfills the duties required by related EU instruction and law;

General business representative of manufacturers (such as authorized dealer), whether or not located within the EEA, should not be confused with European authorized representative required by new methods instructions;

Although the European authorized representative may represent EEA overseas manufacturers to perform the specific duties that EU related instructions and laws required the manufacturer, but manufacturers still shoulder mainly responsibility.

Without the consent of the manufacturer, the European authorized representative cannot change products produced by EU foreign manufacturers alone, even to make the offending products comply with the EU product instruction requirement.　　

Chinese translation usage

The European authorized representative on Chinese translation, will usually translate European Authorised Representative or European Authorized Representative to be European Authorized Representative. Also has translated into: Europe authorized representatives, EU authorized agents, Europe authorized agents, etc. Commonly referred to as: the EU representatives or European generation. Also has use: the EU agency, Europe, representatives of the European agents, etc. Although the European Community (EC) has been replaced by European Union (EU) early in 1993, some people still use “essay authorized representatives” or “essay represents” as proper nouns inTaiwan.