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Enacted Regulation AI Safety

EU CRA

EU Cyber Resilience Act (Regulation (EU) 2024/2847)

Mandatory cybersecurity requirements for all products with digital elements placed on the EU market, including AI software. Requires security by design, vulnerability handling, incident reporting to ENISA, software bills of materials, and CE marking for market access.

Jurisdiction

European Union

Enacted

Nov 20, 2024

Effective

Dec 11, 2027

Enforcement

National market surveillance authorities; ENISA for vulnerability reporting

Entered into force December 10, 2024. Vulnerability reporting obligations begin September 11, 2026. Full product compliance required by December 11, 2027.

European Commission

Why It Matters

Applies cybersecurity requirements to AI systems as 'products with digital elements.' AI software placed on the EU market must meet security-by-design requirements, maintain vulnerability handling processes, and bear CE marking. Non-compliant products lose EU market access entirely.

Recent Developments

Entered into force December 10, 2024. Vulnerability reporting deadline approaching September 2026. Complements EU AI Act and NIS2 Directive.

At a Glance

Applies to

Foundation ModelGeneral ChatbotAI CompanionChatbot Service

Who Must Comply

  • Manufacturers of products with digital elements (including AI software)
  • Importers and distributors of digital products in the EU
  • All entities placing products with digital elements on the EU market

Safety Provisions

  • Security by design: security must be addressed during design and development phases
  • Vulnerability handling and management processes required
  • Incident and vulnerability reporting to ENISA
  • Software Bill of Materials (SBOM) generation required
  • CE marking required for EU market access
  • Security updates throughout product lifecycle
  • Technical documentation for conformity assessment

Exemptions

Medical Devices

Medical devices and in vitro diagnostic devices regulated under separate EU frameworks

  • • Regulated under MDR/IVDR

Motor Vehicles

Motor vehicles and components covered by type-approval regulations

  • • Regulated under vehicle type-approval framework

National Security/Defense

Products for national security or defense purposes

  • • Exclusively for national security or defense

Compliance & Enforcement

Key Dates

Sep 11, 2026

Vulnerability and incident reporting obligations to ENISA begin

Dec 11, 2027

Full compliance required: all products with digital elements must meet essential cybersecurity requirements and bear CE marking

Penalties

€15M or 2.5% revenue (whichever higher)

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European Union

Focus Areas

Active safeguards required

Cite This

APA

European Union. (2024). EU Cyber Resilience Act (Regulation (EU) 2024/2847).

Last updated March 23, 2026. Verify against primary sources before relying on this information.