General Product Safety Regulation (GPSR)

Essential GPSR compliance strategies for AI products. Navigate General Product Safety Regulation requirements with expert insights and tools.

The General Product Safety Regulation (GPSR) represents the European Union's most comprehensive update to product safety legislation in over two decades, fundamentally transforming how manufacturers approach consumer protection—particularly for AI-enabled products.

Understanding the General Product Safety Regulation (GPSR) 2023

What is the General Product Safety Regulation (GPSR) 2023?

The GPSR, officially designated as Regulation 2023/988, replaces the outdated General Product Safety Directive 2001/95/EC with a modernized framework designed for today's digital marketplace. This regulation addresses the evolving landscape of consumer products, with particular emphasis on artificial intelligence, connected devices, and digital services.

Key Objectives of GPSR 2023:

• Enhancing Consumer Safety: Establishes robust safety standards for all consumer products, including AI-enabled systems
• Expanding Scope and Responsibilities: Brings digital products and online marketplaces under comprehensive regulatory oversight
• Strengthening Enforcement: Provides Market Surveillance Authorities with enhanced powers and tools

Implementation and Scope

Effective Date and Applicability: The GPSR became fully applicable on December 13, 2024, creating immediate compliance obligations for manufacturers, importers, and distributors across the EU market.

Affected Stakeholders:

• Manufacturers designing AI-enabled consumer products
• Importers bringing digital products into the European market
• Distributors and online marketplace operators
• Service providers offering AI-related features to consumers

Major Developments in GPSR 2023

Introduction of the EU Responsible Person Requirement

The regulation introduces a mandatory EU Responsible Person designation for non-EU manufacturers, ensuring accountability and traceability throughout globalized supply chains. This requirement strengthens the European Commission's ability to enforce product safety standards across international boundaries.

Focus on Digital and Online Marketplace Compliance

Online marketplace interfaces now bear direct responsibility for product safety, requiring implementation of:

• Enhanced traceability systems with batch numbers and technical documentation
• Digital labels and QR codes for immediate product identification
• Cybersecurity features integrated into product safety assessments

Compliance and Enforcement Framework

Market Surveillance and Data Sharing Practices

The Safety Gate system (formerly RAPEX) has been significantly enhanced to enable real-time data sharing between EU Member States. This creates a unified consumer safety network that rapidly identifies and addresses safety concerns across the European market.

Enhanced Enforcement Powers include:

• Immediate market withdrawal capabilities for unsafe products
• Mandatory test reports and safety assessments
• Strengthened penalties for non-compliance across European Standards

Requirements for Consumer Products under GPSR 2023

Risk Assessments and Technical Documentation must demonstrate:

• Comprehensive product safety throughout the product lifecycle
• Cybersecurity measures integrated into safety standards
• Continuous monitoring capabilities for software updates

Proper Labeling and Conformity Markings require:

• Clear CE mark placement and compliance documentation
• Digital labeling solutions for connected products
• Traceability information accessible to Market Surveillance Authorities

GPSR's Impact on AI-Enabled Products

The Evolution from GPSD to GPSR: Addressing AI Complexity

The transition from the General Product Safety Directive to the GPSR specifically addresses the safety challenges posed by algorithmically mediated technologies. This regulatory evolution recognizes that AI systems require specialized safety protocols that traditional product safety regimes couldn't address.

Enhanced Manufacturer Responsibilities for AI Products

Manufacturers developing AI-enabled products must implement continuous post-market monitoring throughout the product lifecycle, including:

• Real-time performance tracking to identify algorithmic risks
• Proactive safety protocol updates for system changes
• Immediate recall capabilities for AI products demonstrating unsafe behavior

Market Surveillance and AI Traceability

AI systems must maintain sufficient traceability to enable authorities to understand decision-making pathways that impact consumer safety. This includes:

• Transparent documentation of AI training data and algorithms
• Clear audit trails for AI system modifications
• Accessible mechanisms for safety assessments and market recalls

The Relationship Between GPSR and EU AI Act

The EU AI Act and GPSR work in tandem to create comprehensive safety oversight for AI products. For high-risk AI systems—those used in medical devices, critical infrastructure, or law enforcement—compliance with the AI Act inherently satisfies GPSR requirements.

For non-high-risk AI products, the GPSR serves as the primary regulatory framework, requiring organizations to address:

• Potential risks from algorithmic bias or faulty decision-making
• Unintended behaviors in AI system deployment
• Comprehensive safety monitoring and rapid response capabilities

Preparing for GPSR Compliance: Strategic Implementation

Steps for Businesses to Adapt

1. Conduct Comprehensive Risk Assessments

• Evaluate AI system safety throughout development and deployment phases
• Implement robust testing protocols for algorithm performance
• Establish clear safety benchmarks and monitoring systems

2. Implement Effective Post-Market Monitoring

• Deploy continuous performance tracking mechanisms
• Create rapid response protocols for identified safety concerns
• Establish clear communication channels with regulatory authorities

3. Ensure Product Traceability and Documentation

• Maintain comprehensive technical documentation for AI systems
• Implement transparent decision-making audit trails
• Establish accessible recall mechanisms for market withdrawal

4. Develop Compliance Integration Strategies

• Align GPSR requirements with AI regulatory compliance protocols
• Coordinate with broader regulatory frameworks across international markets
• Establish ongoing monitoring of regulatory updates and enforcement changes

Role of EU Member States in GPSR Enforcement

Strengthened Regulatory Authority empowers national authorities to:

• Conduct immediate market interventions for unsafe products
• Share real-time safety data across the European Safety Gate system
• Coordinate enforcement actions across national boundaries

Enhanced Safety Gate System capabilities include:

• Rapid alert distribution for identified safety risks
• Coordinated market withdrawal actions across EU Member States
• Comprehensive consumer empowerment through accessible safety information

Implications for Non-EU Companies

Organizations outside the European Union must establish EU Responsible Person designations and ensure full compliance with GPSR requirements before accessing the European market. This includes:

• Comprehensive understanding of European product safety legislation
• Implementation of EU-compliant safety standards and testing protocols
• Establishment of effective recall and market withdrawal capabilities

Frequently Asked Questions

What is the new General Product Safety Regulation?

The GPSR is the European Union's updated product safety framework, replacing the 2001 directive with comprehensive requirements for modern consumer products, including AI-enabled systems and digital services.

What products are exempt from GPSR?

The GPSR applies to all consumer products placed on the EU market, with specific exemptions for products already covered by comprehensive sectoral legislation and certain second-hand or reconditioned products under specific conditions.

How to get a GPSR certificate?

GPSR compliance is demonstrated through comprehensive technical documentation, risk assessments, and adherence to European Standards, rather than through a single certificate. Organizations must maintain ongoing compliance documentation and safety monitoring.

Does GPSR apply to the USA?

The GPSR applies to all products placed on the European market, regardless of their country of origin, meaning US companies selling to EU consumers must comply with GPSR requirements.

Transform Compliance Into Competitive Advantage

The General Product Safety Regulation represents a significant opportunity for organizations to demonstrate leadership in consumer safety and regulatory excellence. By implementing comprehensive safety standards and proactive monitoring systems, companies can build enhanced consumer trust while ensuring market access across the European Union.

Strategic compliance preparation involves integrating GPSR requirements into product development lifecycles, establishing robust safety monitoring systems, and maintaining ongoing alignment with evolving European regulatory frameworks.

Organizations that approach GPSR compliance proactively will not only meet regulatory requirements but also establish themselves as trusted leaders in the rapidly evolving landscape of AI-enabled consumer products. The regulation's emphasis on transparency, traceability, and continuous safety monitoring creates opportunities for companies to differentiate themselves through demonstrated commitment to consumer protection and regulatory excellence.

Ready to ensure your AI products meet GPSR requirements? Our specialized AI regulatory compliance services provide comprehensive support for navigating the complex intersection of product safety and AI governance, ensuring your organization maintains competitive advantage while meeting all regulatory obligations.

For additional insights on navigating the evolving regulatory landscape, explore our comprehensive analysis of EU AI regulations and discover how regulatory compliance can strengthen your market position.