The Role of an EU Representative (EU-REP, EC-REP, CE-REP)
If your business is located outside the European Union, you are required to appoint an EU representative (EU-REP) for every product sold to end customers within the EU.
This role can be filled by:
- Your own local subsidiary within the EU.
- A specialized compliance company within the EU, often the more practical choice.
Special Considerations for Certain Product Categories
Some product categories, such as medical devices, require specialized compliance services.
Key Duties of the EU Representative:
- Authorized Representation
- The EU-REP must be explicitly authorized by the manufacturer in writing to represent them.
- Documentation and Compliance
- Retain compliance records for at least 10 years after the product is last marketed.
- Provide required information and documents to supervising authorities upon request.
- Risk and Safety Management
- Assess products for risks and compliance.
- Communicate findings to manufacturers and supervising authorities.
- Report risks and product recalls to authorities via the EU Safety Gate platform.
- Labelling Assistance
- Supply the necessary labelling information for EU product sales.
Additional Duties for CE-Certified Products:
If your product requires CE certification, the EU-REP takes on additional responsibilities:
- CE Compliance Representation
- Act as the manufacturer’s representative for all CE compliance matters.
- Assist with affixing the CE mark and issuing declarations of conformity.
- Provide CE documentation to authorities upon request.
- Technical Recordkeeping
- Maintain CE compliance and technical records for at least 10 years after the product is last marketed.
- Risk Reporting and Labelling
- Report risks and recalls to authorities via the EU Safety Gate platform.
- Provide labelling guidance for CE-certified products.
Can Smander.com Serve as Your EU-REP?
We’re working on it!
Stay tuned for updates as we explore ways to simplify product compliance for small businesses.
Why an EU Representative for GPSR also Makes Sense for EU Businesses
EU resident businesses, especially small enterprises, should consider appointing an EU Representative (EU-Rep) under the General Product Safety Regulation (GPSR), not just non-EU companies.
For small businesses, having an EU-Rep can significantly mitigate regulatory risks and reduce the burden of ensuring compliance with EU product safety laws. By designating an EU-Rep, businesses can streamline operations, simplify interactions with EU regulators, and avoid potential fines.
This proactive step not only eases compliance but also boosts consumer trust and safeguards reputation, allowing small businesses to operate more efficiently and focus on their core business.
