Article 4 of the EU AI Act
- Soledad
- May 29
- 2 min read
AI Literacy Under Article 4 of the EU AI Act: A Strategic Obligation for AI Providers and Deployers
The EU Artificial Intelligence AI Act entered into force on 2 February 2025, and with it, Article 4 has introduced a new regulatory expectation: ensuring AI literacy among those who develop, deploy, or interact with AI systems in the EU. But what exactly does this mean—and what must organisations do to stay compliant?
At AF Pharma, we support regulated companies in understanding and implementing complex EU legislation. Here's what you need to know about the new AI literacy obligations and how to integrate them effectively into your organisation.
What Is AI Act Literacy?
AI literacy, as defined by Article 3(56) of the AI Act, refers to the skills, knowledge, and understanding that allow individuals to use AI responsibly, safely, and in compliance with the regulation. This includes awareness of:
The capabilities and limitations of AI systems,
Their potential risks and benefits, and
How to oversee and interact with AI safely.
Who Needs AI Literacy Training?
Under Article 4, AI providers and deployers must ensure AI literacy for:
Their staff directly handling AI systems,
Third parties acting on their behalf (e.g., contractors, partners),
Any person responsible for operating or using AI systems within the organisation.
This responsibility aligns with the transparency (Article 13) and human oversight (Article 14) principles of the AI Act.
What Does Compliance Look Like?
Organisations are not required to implement a one-size-fits-all training programme. Instead, they must adopt a risk-based and context-specific approach. Here’s how:
1. Assess Your Role
Are you a provider (developing AI systems) or a deployer (using third-party AI tools)? Each role carries different responsibilities.
2. Evaluate AI System Risks
Higher-risk AI systems (as defined in Chapter III of the AI Act) require more in-depth training for those who use or manage them.
3. Tailor Training
Training content should reflect:
The employee’s technical background,
The sector where the AI is used (e.g., healthcare vs. marketing),
The system’s purpose and potential impact.
4. Go Beyond Reading Manuals
Simple instructions for use are not enough. Training should actively engage the user in understanding safety, ethics, and oversight of AI.
Documentation and Oversight
There’s no requirement for formal certificates, but companies must:
Document internal actions, such as participation in trainings or guidance sessions,
Keep records available in case of an audit or enforcement investigation,
Periodically review and update training content.
When Does It Apply?
The obligation to ensure AI literacy is already active since 2 February 2025.
Enforcement by national authorities will start on 2 August 2026, but preparation should begin now to avoid non-compliance risks.
Why It Matters
Failure to ensure AI literacy can lead to legal and reputational risks, especially if harm arises from AI misuse. Furthermore, the AI Act applies extraterritorially—meaning non-EU companies targeting the EU market must also comply.
How AF Pharma Can Help
AF Pharma supports companies in regulated industries with compliance solutions, including:
AI Act readiness assessments,
Training design for AI literacy programmes,
Internal documentation and implementation strategy,
Outsourced regulatory support for SMEs and international providers.
Stay ahead of the AI compliance curve. Contact AF Pharma today to discuss how we can help your team meet AI literacy obligations under the new EU regulation.
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