For businesses outside the European Union (EU) that wish to market their products within the EU, appointing an EU Authorised Representative (EUAR) can be essential. This guide outlines the requirements concerning the address and duties of an EU Authorised Representative.
1. Address Requirements for EU Authorised Representative:
Location: The EU Authorised Representative must be established within the European Union. This means they must have a physical, verifiable address in one of the EU Member States.
Details to be Provided:
Official Name: The full, legal name of the EU Authorised Representative.
Physical Address: This should include the street name, number, city, postal code, and country. P.O. Box addresses are not acceptable.
Contact Information: It’s essential to provide accessible communication channels, including a phone number and email address.
Labelling Requirement: The name and address of the EU Authorised Representative must be included on the product or its accompanying documentation. This ensures traceability and provides a point of contact within the EU for regulatory authorities and consumers.
2. Role & Responsibilities of an EU Authorised Representative:
Main Purpose: The EU Authorised Representative acts as the main contact point for EU regulatory authorities on behalf of a non-EU-based manufacturer.
Key Duties Include:
Regulatory Compliance: Ensure that the necessary documentation, including the EU Declaration of Conformity and other relevant records, have been appropriately completed by the manufacturer.
Document Maintenance: Retain and provide access to the product’s technical documentation and the EU Declaration of Conformity upon request from competent authorities.
Vigilance Reporting: Collaborate with regulatory authorities regarding any product safety concerns, necessary corrective actions, or recalls.
Staying Informed: Ensure up-to-date knowledge of EU regulations and directives applicable to the product and inform the manufacturer of any changes or updates.
Availability: Maintain open channels of communication and promptly respond to inquiries from regulatory authorities, providing all required information about the product.
3. Mandate Agreement:
A formal written mandate should be established between the non-EU manufacturer and the EU Authorised Representative. This agreement should outline:
- The specific roles and responsibilities of the EUAR.
- The scope of the EUAR’s authority in representing the manufacturer.
- Terms of cooperation and communication protocols.
- Duration of the agreement and terms for termination.
4. Transitioning or Changing an EU Authorised Representative:
Should a manufacturer decide to change its EU Authorised Representative:
- Ensure a smooth transition of responsibilities and documents.
- Update the representative’s details, including the address, on the product or its accompanying documentation.
- Notify relevant regulatory authorities of the change.
5. Liability Considerations:
The EU Authorised Representative may share liability with the manufacturer for non-compliance or product issues. It’s advisable for both parties to discuss liability aspects and consider having suitable insurance coverage.
In Summary
For non-EU manufacturers, understanding and complying with the requirements related to the EU Authorised Representative is crucial to access the European market legally. Ensure that the representative is well-versed with EU regulations and can effectively liaise with regulatory authorities on the manufacturer’s behalf.