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 Expand Your Business into the European Union with Confidence

Navigating the European Union's (EU) complex regulatory environment can be a daunting task for companies based outside the EU. One of the critical requirements for selling products in the EU is the appointment of an Authorized Representative within the Union. ComplyMarket is here to simplify this process, offering comprehensive Authorized Representative services that ensure your products meet all EU compliance standards, allowing you to focus on growing your business.

Why an EU Authorized Representative is Essential

As per various EU regulations, non-EU manufacturers must appoint an Authorized Representative based in the EU to act on their behalf regarding compliance matters. This representative serves as a liaison between your company and EU regulatory authorities, handling essential tasks such as:

• Compliance Verification: Ensuring your products meet all relevant EU directives and regulations.
• Documentation Management: Maintaining technical files and Declarations of Conformity.
• Communication with Authorities: Acting as the primary contact for market surveillance authorities.
• Incident Reporting: Coordinating responses to any product safety issues.

Failure to appoint an Authorized Representative can lead to:

• Product Seizure at EU Borders: Customs authorities may detain or refuse entry of non-compliant products.
• Legal Liabilities: Facing fines, legal actions, and reputational damage.
• Market Access Loss: Inability to sell on platforms like Amazon and eBay due to non-compliance.

Regulations Requiring an EU Authorized Representative

Several EU regulations mandate the appointment of an Authorized Representative for non-EU manufacturers:

1. General Product Safety Regulation (GPSR)
• Scope: Ensures the safety of consumer products in the EU market.
• Requirement: Non-EU manufacturers must have an EU-based representative to handle compliance and safety obligations.
2. Market Surveillance Regulation (EU) 2019/1020
• Scope: Enhances the enforcement of EU product compliance.
• Requirement: Requires a responsible person within the EU for products to be placed on the market.
3. CE Marking Directives
• Examples:

·       Machinery Directive

·       Low Voltage Directive

·       EMC Directive

·       Medical Devices Regulation

·       In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

·       Personal Protective Equipment Regulation

·       Construction Products Regulation 305/2011

·       Pressure Equipment Directive

·       REACH Regulation

·       Restriction of Hazardous Substances Directive (RoHS)

·       ATEX Directive

·       Toys Safety Directive (2009/48/EC)

·       Radio Equipment Directive

·       Recreational Craft and Personal Watercraft Directive

·       Active Implantable Medical Devices Directive

·       Explosive for Civil Use (CIVEX) Directive

·       Noise Emission Directive

·       Gas Appliances Directive 2009/142/EEC

·       Lifts Directive 1995/16/EC

·       Pyrotechnic Directive 2013/29/EU

·       Measuring Instruments Directive

·       Ecodesign and Energy Efficiency Labelling

 

• Requirement: Products bearing the CE mark must have an EU Authorized Representative if the manufacturer is outside the EU.
3. Cosmetics Regulation (EC) No 1223/2009
• Scope: Governs the safety and compliance of cosmetic products.
• Requirement: A Responsible Person or Authorized Representative within the EU must be appointed.
4. REACH Regulation (EC) No 1907/2006
• Scope: Addresses the production and use of chemical substances.
• Requirement: Non-EU manufacturers must appoint an Only Representative for chemical compliance.
5. General Data Protection Regulation (GDPR) (EU) 2016/679
• Scope: Regulates data protection and privacy in the EU.
• Requirement: Non-EU companies processing EU residents' data must appoint an EU representative.
6. Law on the Single-Use Plastics Fund (Single-Use Plastics Fund Act - EWKFondsG)
7.  Others

 

ComplyMarket's Comprehensive Authorized Representative Services

At ComplyMarket, we offer a full suite of services to ensure your seamless entry into the EU market:

1. Regulatory Compliance Management
• Expert Guidance: Our team stays abreast of all EU regulations, ensuring your products comply with the latest standards.
• Technical Documentation: We assist in preparing and maintaining all necessary documentation, including Declarations of Conformity and technical files.
2. Liaison with EU Authorities
• Primary Contact Point: We act as your official representative in communications with EU market surveillance and regulatory authorities.
• Incident Coordination: In the event of product safety issues, we coordinate with authorities to address and resolve concerns promptly.
3. Product Labeling and Information Compliance
• Label Verification: Ensure your product labels meet EU requirements, including necessary identification and contact information.
• Address Inclusion: Our EU address is included on your product packaging, as mandated by regulations.
4. Continuous Support and Monitoring
• Regulatory Updates: Stay informed about changes in EU regulations that may affect your products.
• Ongoing Consultation: Receive expert advice on compliance strategies and best practices.
5. Data Protection Representation (GDPR)
• GDPR Compliance: We act as your EU representative for data protection matters, ensuring you meet all GDPR requirements.
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Why Choose ComplyMarket

• Expertise Across Multiple Regulations: Our extensive knowledge covers all relevant EU directives and regulations requiring an Authorized Representative.
• Personalized Solutions: We tailor our services to meet your specific industry and product needs.
• Confidentiality and Trust: Your proprietary information and documentation are handled with the utmost confidentiality.
• Efficiency and Reliability: Our streamlined processes minimize delays, helping you enter the market faster.
• Competitive Pricing: We offer cost-effective solutions without compromising on quality.

How to Appoint ComplyMarket as Your Authorized Representative

1. Contact Us
• Get in Touch: Reach out to discuss your needs and receive a customized proposal.
2. Sign a Service Agreement
• Written Mandate: Provide us with a written mandate specifying the tasks you delegate to us, as required by EU regulations.
3. Submit Necessary Documentation
• Documentation Review: Supply all relevant technical files, test reports, and compliance documents for verification.
4. Update Product Labels and Packaging
• Compliance Assurance: Include ComplyMarket's name and EU address on your product labels, packaging, and user manuals.
5. Launch Your Products in the EU
• Market Entry: With ComplyMarket as your Authorized Representative, confidently distribute your products throughout the European Union.

Get Started with ComplyMarket Today

Don't let regulatory complexities impede your business expansion into the EU. Let ComplyMarket be your trusted partner in achieving full compliance across all necessary EU directives and regulations.

• Email: info@complymarket.com
• Phone: +491637819457
• Address: ComplyMarket, 44 Tal Street, 80331 Munich, Germany
• Website: www.complymarket.com