What is an EU Authorized Representative (EU-Rep)?

An EU Authorized Representative, also known as a European Representative (EU-Rep), acts on behalf of manufacturers outside the EU to ensure compliance with EU regulations.

EU Regulations and the Role of an EU Authorized Representative

1. CE Certification Requirement: According to EU regulations, a manufacturer must have an agreement with an EU-Rep to apply for CE certification.

2. Product Labeling: After obtaining CE certification, the product packaging must display both the CE logo and the name and address of the EU-Rep. While the CE mark indicates the product's safety compliance, the EU-Rep ensures traceability and can be contacted by customers, customs, or EU authorities in case of any issues.

3. Technical Documentation (TCF): When applying for CE certification, manufacturers are required to create a complete set of English technical documentation (TCF) covering risk analysis and essential requirement checks.

4. EU Import Requirements: Products marked with the CE logo imported from outside the EU must have the EU-Rep’s name and address clearly printed on the packaging, label, and user manual.

5. Maintenance of Technical Files: The EU-Rep must maintain up-to-date technical files for all products bearing the CE mark. These documents must be readily available for EU supervisory authorities and retained by the EU-Rep for at least five years after the final batch of products is marketed.

6. Incident Monitoring System: Manufacturers outside the EU are required to establish an effective incident monitoring system within the EU. The EU-Rep assists with accident reports, notifications, and product recalls.

7. Device Registration: The EU-Rep may handle registration with EU authorities on behalf of the manufacturer for medical devices.

8. Free Sale Certificate: The EU-Rep may also apply for a Free Sale Certificate on behalf of the manufacturer.

Process for Appointing an EU-Rep

1. Provide the CE certificate and report.

2. Complete the application form.

3. Sign the contract and make payment.

4. Receive the signed EU-Rep information.

Timeline

The process typically takes 3-5 business days.