EU Artificial Intelligence Act

Modulais (a brand of Creadus Oy, Jyväskylä, Finland) commits to full compliance with the EU Artificial Intelligence Act (Regulation (EU) 2024/1689) and related delegated and implementing acts, especially in providing compliant AI solutions within the EU and globally.

1. Applicability & Risk-Based Framework

Modulais adheres to the AI Act’s risk-tier classification:

  • 1. Unacceptable ‑ Risk Systems are strictly excluded from our solutions.
  • High ‑ Risk Systems undergo full conformity assessment, CE marking, post‑market monitoring, and documentation per Articles 8–22 and 16–27.
  • General ‑ Purpose AI Models (GPAI) are treated according to Chapter V, including transparency and documentation obligations under Articles 53–55 if applicable.
  • Limited/Minimal ‑ Risk Systems platform functions comply accordingly with transparency obligations.

2. Obligations for General‑Purpose AI Model Providers (Articles 53–55)

Where Modulais provides foundational or general‑purpose AI models, we commit to:

  • Maintaining up‑to‑date technical documentation of model training, validation, and testing, following Annex XI standards, for submission upon request to the EU AI Office or national authorities.
  • Supplying downstream integrators (clients or partners) with technical summaries—consistent with Annex XII—to help them embed the model while protecting trade secrets.
  • Publishing training data summaries and complying with EU copyright rules using state‑of‑the‑art tools as per Article 53(c) and (d).

If a model qualifies as GPAI with systemic risk, we also:

  • Conduct standardised risk evaluations, adversarial testing, and mitigation planning.
  • Report serious incidents promptly to the EU AI Office and national authorities.
  • Ensure cybersecurity safeguards protect both model and infrastructure.

Compliance may be demonstrated through adherence to the voluntary General‑Purpose AI Code of Practice, which provides practical templates for transparency, copyright and safety obligations — approved by the EU in July 2025.

3. Obligations for High‑Risk AI System Providers (Articles 8–16, 43–49)

When delivering high‑risk AI systems (e.g., in regulated sectors such as healthcare, finance, or critical infrastructure), Modulais will:

  • Establish and document a full Quality Management System and risk management framework per Article 9, 17.
  • Complete mandatory conformity assessments before market placement (Article 43), issue an EU Declaration of Conformity (Article 47), and apply CE marking (Article 48).
  • Register products in the official EU AI database if required by Annex III systems (Article 49).
  • Implement post-market monitoring, documentation of logs, and incident reporting in accordance with Articles 72–73 and 19.

4. Governance & Assistance

  • Modulais maintains technical documentation, risk assessments, and compliance logs centrally.
  • Our team offers guidance to clients on classification, compliance mapping, and adaptation according to model risk levels.
  • We support controllers and integrators with necessary documentation, transparency materials, and training to uphold their own obligations under the AI Act.

5. Conformity via Codes or Alternatives

Where Modulais does not subscribe to an EU-recognised code, we document alternative means of compliance that satisfy Articles 53 and 55—or Articles 16 and related high-risk provisions—and remain ready for review by the AI Office or supervisory authorities.

6. Contact & Further Assistance

To request Modellation, certifications, documentation (e.g., Annex XI/XII technical files, declarations of conformity, code compliance letters, or evidence of alternative measures), or to arrange compliance planning sessions, please contact our AI Compliance Officer:

[email protected]

Modulais ensures that your AI‑powered automation solutions are fully aligned with European standards—from transparency and safety through to legal conformity. We build smart AI infrastructure that's compliant, risk‑aware, and tailored for European responsible AI deployment.

 

Compliant, Same as Our Solutions. No Doubt.

Get in touch if you have questions - About the EU Act, solutions and outcomes that would suit you, or life in general.