Why Start with a Regulatory Classification?
Before implementing controls, preparing documentation, or carrying out a more in-depth assessment, it is essential to determine which AI systems the organisation uses, what they are used for, and which obligations each use case may trigger.
Aicertia’s AI Risk Classification and Regulatory Impact Assessment provides an initial structured view of the organisation’s exposure to the EU AI Act, helps identify the cases that require priority attention, and defines the appropriate next steps.
What Do We Assess?
- AI system and use case — We identify the solution being used, its purpose, users, affected persons, relevant processes, and the extent to which it influences decisions.
- Applicability of the EU AI Act — We assess whether the solution and its use fall within the definition and scope of the Regulation.
- Organisation’s role — We determine the company’s position within the AI value chain — for example, provider, deployer, importer, or distributor — and the obligations associated with that role.
- Prohibited AI practices — We carry out a screening for potential use cases that may fall within the prohibited practices established under the EU AI Act.
- Regulatory classification — We assess whether the use case may fall within a High-Risk category and review other relevant regulatory obligations, including transparency requirements where applicable.
- Regulatory impact and obligations — We identify the main applicable obligations, initial gaps, and priority actions based on the use case, risk level, and organisation’s role.
Deliverables
- Technical Regulatory Classification Report.
- Regulatory Profile for the AI system or use case.
- Identification of roles and responsibilities: Provider, Deployer, and third parties.
- Screening of Prohibited AI Practices — Article 5.
- Assessment of potential High-Risk classification — Annex III.
- Assessment of Transparency Obligations — Article 50.
- Assessment of applicable AI Literacy requirements — Article 4.
- Obligations and Findings Matrix.
- Initial Regulatory Gap Analysis.
- Identification of priority regulatory risks.
- Compliance by Design recommendations for systems under development.
- Executive Action Roadmap.
- Recommendation for next phases: Pre-Assessment, Transparency, AI Literacy, Remediation, or Continuous Governance.
Ejemplo – Resultado de la Clasificación
| Assessed Area | Result |
|---|---|
| EU AI Act Applicability | ✅ Applicable |
| Organisation’s Role | Deployer |
| Prohibited Practices | 🟢 None identified |
| Potential High-Risk Classification | 🟠 Further assessment required |
| Article 50 Transparency Obligations | ✅ Applicable |
| Regulatory Priority | 🔴 High |
| Next Step | Pre-Assessment |
Final Price
- From €995 — For organisations that need to identify which regulatory requirements apply to their Artificial Intelligence systems and use cases.For organisations with multiple systems, departments, or use cases, we offer Business and Corporate assessments tailored to the required scope.
- Essential – 995 €
- Business –1.995/2.995 €C
- Corporate – custom pricing
Does your system show indicators of High-Risk classification?
- If, during the Classification, we identify that a system may fall within one of the High-Risk categories under the EU AI Act, the recommended next step is to carry out an EU AI Act Pre-Assessment — High-Risk to assess its level of readiness in greater depth and identify existing compliance gaps.
Understand Your AI Regulatory Position
We assess your AI systems and use cases to determine their regulatory classification, applicable obligations, and potential impact under the EU AI Act.
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