Regulation (EU) 2024/1689
EU AI Act module
Classify, screen, document and audit AI systems against the EU AI Act. Every verdict is computed by a deterministic Prolog engine — auditable proofs, not checklists.
The AI Act module reuses the same formal-verification engine as the FDA tools: your answers are compiled into Prolog facts and checked against the regulation's rules, so each classification and obligation is provably derived — not an LLM opinion.
The workflow
Register a system
Classify risk
Document & audit
Assess
System registry
Inventory your AI systems and track each one's classification, obligations and validation status.
Risk classification
A Prolog-backed wizard that decides the risk tier in priority order.
- Article 3 scope check
- Article 5 prohibited practices (terminal)
- GPAI / systemic-risk models
- Article 6 & Annex III high-risk uses
- Article 50 limited / minimal
Screen & document
Article 5 screening
Check a system against the eight prohibited AI practices — a prohibited verdict is terminal.
Article 50 transparency
Disclosure and synthetic-content labelling obligations for limited-risk systems.
GPAI obligations
General-purpose AI: transparency, copyright policy and training-data summary (Art. 53), plus systemic-risk duties.
Annex IV technical file
Build the nine-section technical documentation required for high-risk systems.
Operate
Full AI Act audit
An article-by-article audit that validates each provision and produces an evidence report.
Cross-regulation
See where FDA 21 CFR and the EU AI Act overlap (e.g. SaMD ↔ high-risk, Part 11 ↔ data governance).
How classification is decided
The engine evaluates outcomes in strict priority order and returns the first that matches:
- Prohibited — the system meets an Article 5 practice (terminal).
- GPAI / systemic — a general-purpose model, flagged systemic above the compute threshold.
- High-risk — an Article 6 safety component or a listed Annex III use (unless Art. 6(3) exempt).
- Limited — Article 50 transparency obligations apply.
- Minimal — no specific obligations beyond voluntary codes.
Because the decision is a Prolog program, the basis for every verdict is recorded as a list of the exact rules that fired — ready to export as evidence.