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Key Changes in the GPSR: What Manufacturers Need to Know

Dr. Elena Kowalski
Dr. Elena Kowalski Regulatory Affairs Director
May 15, 2025
12 min read

The General Product Safety Regulation (GPSR) represents the most significant overhaul of EU product safety legislation in decades. Coming into full effect on December 13, 2024, this regulation replaces the General Product Safety Directive (GPSD) and introduces sweeping changes that affect manufacturers, importers, distributors, and online marketplaces. This article examines the key changes and what they mean for your business.

From Directive to Regulation: Why It Matters

The shift from a directive to a regulation is more than a technical change. Unlike directives, which require implementation into national law by each EU member state (often with variations), regulations apply directly and uniformly across all member states. This means:

  • Consistent requirements across all EU markets
  • No delays or discrepancies in national implementation
  • Greater legal certainty for businesses operating across multiple EU countries

For manufacturers, this translates to simplified compliance processes and reduced costs associated with navigating different national interpretations of product safety requirements.

Expanded Scope and Product Coverage

The GPSR significantly expands its scope compared to the previous directive. Key expansions include:

Digital Products and Connected Devices

The definition of "product" now explicitly includes software and connected devices, whether the connectivity is embedded or not. This means manufacturers of IoT devices, smart appliances, and standalone software must now ensure their products meet GPSR requirements.

Second-hand Products

Previously excluded, second-hand products that have been substantially modified now fall under the GPSR's scope. Refurbishers and resellers need to be aware of their new obligations.

Products Provided as Part of a Service

The GPSR clarifies that products provided to consumers as part of a service (e.g., rental equipment) are subject to the same safety requirements as products sold directly.

Case Example: Smart Home Devices

A manufacturer of smart thermostats previously focused primarily on hardware safety. Under GPSR, they must now also ensure that the software controlling the device is safe, that cybersecurity risks are addressed, and that the device remains safe throughout its lifecycle, including after software updates.

Enhanced Obligations for Economic Operators

The GPSR introduces more stringent and detailed obligations for all economic operators in the supply chain:

For Manufacturers

  • Risk Assessment: Formal risk assessments must be conducted and documented before placing products on the market
  • Technical Documentation: More comprehensive technical files must be maintained, including risk assessments and test reports
  • Post-Market Surveillance: Enhanced requirements for monitoring product safety after market placement
  • Incident Reporting: Serious incidents must be reported through the Safety Business Gateway within two working days
Team reviewing GPSR compliance documentation

A compliance team reviewing technical documentation requirements under the new GPSR framework

For Importers and Distributors

Importers and distributors face expanded due diligence requirements:

  • Verification that manufacturers have conducted appropriate conformity assessments
  • Ensuring products bear required markings and are accompanied by necessary documentation
  • Sample testing of products when appropriate based on risks
  • Maintaining a register of complaints and product recalls

New Obligations for Online Marketplaces

Perhaps the most significant expansion of scope is the inclusion of online marketplaces as economic operators with specific obligations:

  • Establishing a single point of contact for market surveillance authorities
  • Verifying that product listings contain required information
  • Responding to notices about illegal product listings within two working days
  • Regularly checking for product recalls and dangerous products
  • Informing consumers about recalled or dangerous products purchased through their platform

This represents a fundamental shift in responsibility for online platforms, which previously had limited liability for third-party products sold through their services.

"The inclusion of online marketplaces as economic operators with specific obligations is one of the most significant changes in the GPSR. It acknowledges the reality of modern commerce and closes a major gap in consumer protection."

Enhanced Traceability Requirements

Traceability has been significantly strengthened under the GPSR:

Digital Product Passport

While not fully implemented yet, the GPSR lays groundwork for digital product passports that will contain key information about a product's origin, composition, repair and dismantling possibilities, and end-of-life handling.

Information Requirements

Products must be accompanied by more detailed information, including:

  • The manufacturer's name, registered trade name or trademark, and contact details
  • The importer's information (if applicable)
  • Product identification information
  • Safety warnings and instructions in the language of each member state where the product is made available

Product Recalls and Market Surveillance

The GPSR strengthens the recall framework and market surveillance mechanisms:

Enhanced Recall Requirements

When a product recall is necessary, manufacturers must now:

  • Offer consumers a choice between repair, replacement, or refund (at least equal to the product's purchase value)
  • Ensure recall notices are effective in reaching affected consumers
  • Maintain high visibility of recall information on websites for at least 12 months

Strengthened Market Surveillance

The regulation enhances coordination between national market surveillance authorities and provides them with additional powers to:

  • Conduct mystery shopping to identify non-compliant products
  • Order the removal of product listings from online interfaces
  • Impose more significant penalties for non-compliance

Penalties for Non-Compliance

The GPSR introduces a harmonized approach to penalties, with maximum fines of:

  • €10,000,000 or 6% of annual turnover (whichever is higher) for serious infringements
  • €2,000,000 or 4% of annual turnover for less severe infringements

These penalties represent a significant increase compared to the previous regime and underscore the EU's commitment to product safety.

Practical Steps for Manufacturers

To ensure compliance with the GPSR, manufacturers should take the following steps:

  1. Review product portfolio: Assess which products fall under the expanded scope of the GPSR
  2. Update risk assessment procedures: Ensure they meet the enhanced requirements
  3. Revise technical documentation: Update to include all newly required information
  4. Enhance traceability systems: Prepare for more stringent traceability requirements
  5. Review recall procedures: Update to comply with new requirements
  6. Train staff: Ensure all relevant personnel understand the new obligations
  7. Audit supply chain partners: Verify that importers and distributors understand their obligations

Conclusion

The GPSR represents a significant evolution in EU product safety legislation, reflecting changes in technology, business models, and consumer expectations. While compliance will require investment and adaptation, the regulation ultimately creates a more level playing field and enhances consumer protection across the EU market.

Manufacturers who proactively address these changes will not only ensure compliance but may gain competitive advantages through enhanced consumer trust and streamlined operations across the EU single market.

For personalized guidance on GPSR compliance, contact our expert team at GPSR Compliance Gate.

GPSR Product Safety EU Regulations Compliance Manufacturers
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Dr. Elena Kowalski

Regulatory Affairs Director | PhD in International Trade Law

Dr. Elena Kowalski has over 15 years of experience in product safety and regulatory compliance. She specializes in EU product regulations and has advised numerous multinational companies on navigating complex regulatory landscapes.

View all articles by Dr. Kowalski →

Comments (8)

Leave a comment

8 comments
Robert Johnson
Robert Johnson
May 16, 2025 • 10:24 AM

Excellent overview of the key changes! As an importer, I'm particularly concerned about the enhanced due diligence requirements. Has anyone implemented a systematic approach to verify that manufacturers have conducted appropriate conformity assessments?

Dr. Elena Kowalski
Dr. Elena Kowalski Author
May 16, 2025 • 11:45 AM

Great question, Robert. We're developing a comprehensive checklist for importers that includes verification points for manufacturer conformity assessments. I'll be covering this in detail in my next article on due diligence procedures. Feel free to contact me directly if you need specific guidance for your industry.

Sophia Martinez
Sophia Martinez
May 15, 2025 • 4:32 PM

The penalties are quite significant! €10 million or 6% of annual turnover could be devastating for smaller businesses. I wonder if there will be any consideration for company size in enforcement actions, or if SMEs will be held to the same standards as large corporations.

Michael Chen
Michael Chen
May 15, 2025 • 2:17 PM

As someone working in the IoT industry, I'm particularly interested in the expanded definition of "product" to include software and connected devices. Does anyone know if there will be specific guidance documents for digital products? The cybersecurity aspects seem quite broad.

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