ORBIS Compliance

Spain Launches Public Consultation on the Simplification of the EU Artificial Intelligence Act

Published /Spain

The Spanish Ministry for Digital Transformation and the Civil Service has launched a public consultation on proposed adjustments to Regulation (EU) 2024/1689 (Artificial Intelligence Act). The initiative aims to support a more practical and proportionate implementation of the AI Act by reducing unnecessary administrative burdens while maintaining high levels of protection for safety, health and fundamental rights. The consultation focuses on compliance simplification, documentation requirements, post-market monitoring, AI regulatory sandboxes and proportionality measures for SMEs, and will contribute to Spain’s input into the ongoing EU-level legislative process.

Why?

The Spanish public consultation outlines proposed adjustments to the EU Artificial Intelligence Act (Regulation (EU) 2024/1689) aimed at making the regulatory framework more practicable and proportionate before full application in 2027. These changes would simplify documentation, clarify requirements for post-market monitoring, and introduce flexibility for small and medium-sized enterprises, while maintaining high levels of safety, security, and fundamental rights protections. The impact is primarily regulatory and operational, improving legal clarity and reducing compliance burdens rather than imposing new product-level technical standards.

Who?

  • Providers and deployers of AI systems in Spain
  • SMEs and midcap companies using or developing AI
  • Administrations and public sector entities using AI
  • AI governance and supervisory bodies
  • Stakeholders participating in the national consultation process

Conclusion

This represents a medium-impact regulatory adjustment: important for practical compliance and legal clarity in implementing the EU AI regulatory framework, but with limited immediate impact on product design requirements, technical standards, or certification regimes.

Regulatory Authority

MTDFP

Regulatory Impact

Impact TypeStatus
Top Priority
Type Certificate
Spectrum Bands
Import Changes (HS Codes)
Standard Changes
Product Changes
Label Changes