AI & European Compliance: What the AI Act Changes for Startups, SMEs and Associations

Since August 1, 2024, the European Regulation on Artificial Intelligence (AI Act) has come into force. It is the first legislation in the world to regulate the development and use of AI. The objective: to protect fundamental rights, strengthen trust, but also stimulate responsible innovation.

👉 Official text on info.gouv.fr: What is the AI Act?

A risk-based approach

The AI Act classifies AI systems into 4 categories:

  • Unacceptable risk → strictly prohibited (social scoring, manipulation of people's vulnerability, real-time biometrics in public places).
  • High risk → subject to strict requirements (reliable data, CE marking, human supervision): education, employment, health, justice, biometrics.
  • Limited risk → mandatory transparency (e.g. chatbots or generative AI must report that they produce artificial content).
  • Minimal risk → no special obligations (e.g. spam filters, simple recommendation AI).

Key timeline:

  • February 2, 2025 : ban on AIs with unacceptable risk.
  • August 2, 2025 : rules for general-purpose AI models (including large generative models).
  • 2026-2027 : complete application for high-risk systems and integration into regulated products.

New obligations for businesses

Any organization that supplies, imports, distributes or deploys an AI system in the EU is concerned: startups, SMEs, associations, administrations.

For digital players:

  • The systems high risk will have to obtain CE marking, be registered in a European database and comply with strict data governance.
  • AI models generative must clearly indicate that their content is artificial and respect copyright.
  • Companies will have to ensure traceability, robustness, human supervision and cybersecurity.

Good news: regulatory sandboxes will allow young companies to test their solutions under supervision, with a certain legal flexibility.

Support for innovation: the AI Innovation Package

In parallel with this legal framework, the Commission launched in January 2024 a AI innovation package :

  • Privileged access for startups to European supercomputers (AI Factories).
  • Creation of a AI Office to oversee the AI Act and support the ecosystem.
  • 4 billion euros of public and private investments by 2027 via Horizon Europe, Digital Europe and InvestEU.
  • Deployment of sectoral sandboxes and language infrastructures to strengthen European diversity (Alliance for Language Technologies).

👉 Official press release: Commission launches AI innovation package

Challenges for startups, SMEs and associations

  • Startups & scale-ups : opportunity to differentiate through compliance and transparency, but vigilance on compliance costs.
  • SMEs : need to integrate governance and quality processes from the design stage, while taking advantage of funding and sandboxes for security testing.
  • Associations & public actors : strong impact in sensitive areas (health, education, social). Compliance with obligations will strengthen user confidence.

What to remember

The AI Act is not just a regulatory constraint: it is also a strategic opportunityOrganizations that anticipate compliance today will be able to:
✅ easier access to European markets,
✅ benefit from EU funding and infrastructure,
✅ strengthen the trust of customers and partners.

For startups, SMEs and associations, it is urgent to set up a progressive compliance plan (classification of AI uses, documentation, data governance), while understanding the levers of financing and support.

📌 To go further:

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