EU Authorized Representative
In order to better protect EU consumers and the environment, EU law requires that in order to achieve traceability of products, manufacturers placing CE-marked 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 European Economic Area EEA (including EU and EFTA), its product must be marked with the name and contact address of both the manufacturer and the manufacturer's EU authorized representative. For example: In order to improve the efficiency of overall market surveillance, the European Commission will be responsible for checking the efficiency of market surveillance and require all member states to meet minimum legal requirements and strengthen cooperation and exchanges. In addition, the European Commission will cooperate with customs and cooperate with relevant stakeholders (manufacturers, EU authorized representatives, importers, distributors) to establish a product traceability system. The European Commission first focuses on high-risk areas, such as medical devices.
Definition and Duties of Authorized Representatives of the European Union
The European Authorised Representative (European Authorised Representative or European Authorized Representative) refers to a natural or legal person explicitly designated by a manufacturer located outside the EEA (including EU and EFTA). The natural or legal person may perform, on behalf of the manufacturer outside the EEA, the specific duties required of the manufacturer by relevant EU directives and laws. The new method directive requires that the EU authorized representative must be located in the European Economic Area and have a business registered address (some countries also require that the EU authorized representative must have a company registration number or EU VAT registration number);
The governments and competent authorities of EEA member states can always go directly to the authorized representatives of the EU to check whether the manufacturers outside the EEA have performed their duties required by the relevant EU directives and laws; the general commercial representatives of the manufacturers (such as authorized distributors) Whether it is located in the European Economic Area should not be confused with the EU authorized representative required by the new method directive; although the EU authorized representative can perform on behalf of manufacturers outside the EEA the specific duties required by the EU relevant directives and laws for the manufacturer , But the manufacturer remains the party with the primary responsibility.
Without the manufacturer's consent, the authorized representative of the European Union may not independently change the products manufactured by manufacturers outside the EEA, even to make the non-compliant products comply with the requirements of the EU product directive.
Why do you need a CE EU Representative?
In order to ensure the safety of products sold in the EU market, and to ensure that CE-labeled products imported from outside the EU meet EU requirements for consumer, property, and environmental protection, EU law Manufacturers outside the country have the following requirements: Appoint an EU authorized representative: Manufacturers outside the EU must appoint an Authorized Representative established in the EU + EFTA's 28 member states to specifically represent manufacturing outside the EU It deals with governments and agencies in 28 European countries.
The authorized representative must be printed on the packaging: the CE-marked products imported from outside the EU must be clearly marked with the name and address of the manufacturer's EU authorized representative on the packaging, label, and instruction manual. "Technical files" must be stored in the EU authorized representative office: The EU authorized representative office must keep the latest "Technical Files" of all products with CE marking. In accordance with EU law, ensure that it can be provided to the CE supervisory authorities in the EU for inspection at any time. After the last batch of products has been put on the market, their technical documents should be retained at the EU authorized representative office for at least 5 years. Establishing an "accident prevention and supervision system": Manufacturers outside the EU must establish an effective "accident prevention and supervision system" within the EU, and assist their product accident reports, notifications, recalls, etc. through their EU authorized representatives.
As a professional, non-participating and neutral EU authorized representative company, SAFENET has provided related services for many customers.