What is CE Certification and EU Authorized Representative?

What is an eu authorized representative

An EU Authorized Representative, also referred to as a european representative.

EU Regulatory Requirements and the Role of the EU Authorized Representative

1. In accordance with EU regulations, an EU Authorized Representative Agreement is mandatory when applying for CE certification.

2. In accordance with EU regulations, after obtaining CE certification, products must bear the CE logo on their packaging, along with the name and address of the EU Authorized Representative. The ce mark signifies that the product has passed safety certification, while the EU Authorized Representative ensures traceability. In the event of any inquiries from customers, customs authorities, or EU government bodies, they can directly contact the EU Authorized Representative for communication and resolution.

3. When a company applies for CE certification, in compliance with the relevant directives, the products must be accompanied by a complete set of English Technical Construction Files (TCF), which include risk analysis and essential requirement assessments.

4. The name and address of the manufacturer's EU Authorized Representative (EC-Representative) must be clearly printed on the packaging, labels, and user manuals of products bearing the CE mark imported from outside the EU.

5. The latest Technical Files for all products bearing the CE mark must be kept at the EU Authorized Representative. In compliance with EU law, these files must be readily available for inspection by CE surveillance authorities within the EU at any time. The Technical Files must be retained by the EU Authorized Representative for a minimum of 5 years after the last batch of products has been placed on the market.

6. Establishment of an "Accident Prevention and Surveillance System": Manufacturers located outside the EU must establish an effective Accident Prevention and Surveillance System within the EU, with the assistance of their EU Authorized Representative for product incident reporting, notifications, recalls, and other related matters.

7. The EU Authorized Representative may also assist the manufacturer in applying for device registration with the relevant EU competent authorities upon the manufacturer's request.

8. The EU Authorized Representative may also assist the manufacturer in applying for a Free Sale Certificate upon the manufacturer's request.

EU Authorized Representative Process

9. Provide the product ce certificate and test reports.

10. Complete the application form.

11. Sign the contract (and make payment).

12. Return the signed EU Authorized Representative information.

Lead Time

3-5 working days