What is an EU Representative?

An EU Representative, also known as a European Authorized Representative (EAR), is a legally designated entity required by EU regulations to represent non-EU manufacturers within the European Union.

EU Regulations and the Role of an Authorized Representative:

1. According to EU regulations, when applying for CE certification, a valid EU Representative agreement is mandatory.

2. After obtaining CE certification, the product packaging must display the CE logo along with the name and address of the EU Representative. The CE mark indicates the product's safety compliance, while the EU Representative ensures traceability. Customers, customs, or EU authorities can contact the representative to address any issues.

3. When applying for CE certification, companies are required to submit a complete set of technical documents (TCF), which includes a risk analysis and basic compliance checks.

4. Products imported into the EU from outside the EU must clearly display the name and address of the manufacturer’s EU Authorized Representative on the product packaging, labels, and user manuals.

5. The EU Representative must keep the latest "technical files" for all CE-marked products. According to EU law, these documents must be available for inspection by EU regulatory authorities at any time. Technical documents must be retained by the representative for at least 5 years after the last batch of the product is placed on the market.

6. The manufacturer must establish an "incident prevention monitoring system" within the EU. The EU Representative assists with product incident reports, notices, and recalls.

7. The EU Representative may also assist the manufacturer in registering medical devices with the relevant EU authorities.

8. They can also assist with applying for a Certificate of Free Sale (CFS) on behalf of the manufacturer.

EU Representative Process:

1. Provide the product’s CE certificate and report.

2. Complete the application form.

3. Sign the contract and proceed with payment.

4. Return the signed EU Representative information.

Timeframe:

3-5 working days.