Background knowledge
In order to better protect consumers and the environment in the EU, in order to achieve product Traceability, EU law requires manufacturers to put CE marking products on the EU market must be marked with the manufacturer's name and contact address; If the manufacturer is from a country outside the EEA(including the EU and EFTA), the product must be marked with the name and contact address of both the manufacturer and the EU authorised representative.
In order to improve the efficiency of overall market supervision, the European Commission requires that all member States should meet the minimum legal requirements, the European Commission and customs, and cooperate with relevant parties (manufacturers, EU authorized representatives, importers, distributors) to establish a sound product traceability system. The Commission is focusing first on high-risk areas, such as medical devices.
MDR 2017/745/EU and IVDR 2017/746/EU both require non-EU manufacturers to have an EU authorised representative.
Definition of European Authorised Representative
European Authorised Representative or European Authorised Representative is a company explicitly appointed by a manufacturer located outside the EEA(including the EU and EFTA). The company may act on behalf of a manufacturer outside the EEA to perform specific duties required of that manufacturer by the relevant directives and laws of the European Union.
The new Methods Directive requires the EU authorised representative to be located in the EEA and to have a business registered address (some countries also require the EU Authorised representative to have a company registration number or EU VAT registration number);
The governments and competent authorities of EEA Member States may at any time directly approach the EU authorized representatives to verify whether manufacturers outside the EEA have fulfilled the duties required by the relevant EU directives and laws;
A general commercial representative of a manufacturer (e.g. an authorised dealer), whether or not located in the EEA, should not be confused with an authorised representative of the EU as required by the new Methods Directive;
Although the EU authorised representative may perform specific duties on behalf of a manufacturer outside the EEA as required by the relevant EU directives and laws, the manufacturer is still the party that bears the primary responsibility.
Without the consent of the manufacturer, the authorised representative of the European Union shall not independently alter the products manufactured by manufacturers outside the EEA, even in order to make the offending products comply with the requirements of the EU Product Directive.
Chinese translation usage
In Chinese translation, European Authorised Representative or European Authorized Representative is usually translated as: EU Authorised Representative. Also translated as: European Authorized Representative, European Union Authorized Agent, European Authorized agent, etc. Often shortened to: European Union representative or European representative. Also used: EU agent, European Representative, European Agent, etc. Although the European Community (EC-European Community) was replaced by the European Union (EU-European Union) in 1993, the term "authorized representative of the European Community" or "representative of the European Community" is still used in Taiwan.
The role of the EU authorised representative
1、 The authorized representative of the European Union (referred to as EU representative) acts as the legal entity of manufacturers outside the European Union and performs the duties of manufacturers in accordance with the relevant official directives of the EU.
2、The EU authorized representative shall stand in the position of the manufacturer and communicate with the competent authorities of the EU (regarding conformity statements, EU labeling and language requirements, accident reports, notices of clinical studies, certificates of free sale or market access, and certificates of product registration, etc.).
3、The authorized representative must be printed on the packaging: the packaging, labels and instructions of the products imported from outside the EU with the CE mark must be clearly printed on the manufacturer's EU authorized representative (EU authorized agent) name and address.
4、"Technical documents" must be saved in the EU authorized representative (EU authorized agent) : the EU authorized representative (EU authorized agent) must keep the latest, all products with CE mark Technical Files. According to EU law, ensure that it can be provided to the CE supervision authority in the EU at any time and in a timely manner. After the last batch of products is placed on the market, its technical documentation shall be retained with the EU authorised representative (EU Authorised Agent) for at least 5 years.
5、The establishment of "accident prevention and supervision system" : Manufacturers outside the EU must establish an effective "accident prevention and supervision system" in the EU, through its EU authorized representative (EU authorized agent) to provide assistance in product accident reporting, notification, recall, etc.
Lingfu Technology can provide the following EU authorized representative services for enterprises:
- Acting on behalf of non-EU manufacturers in dealings with EU authorities.
- EU authorized representatives maintain up-to-date Technical Files on products with CE marking to ensure that they are readily and promptly available for review by EU authorities.
- Reduce intermediates for customers, save time and money, and simplify the process of bringing products to market in compliance with current European regulations.
- Provide timely information communication and assistance to solve any problems in the sale of products in the EU
