The classic trap
Recital 47 explains why the AI Act automatically classifies as high-risk any AI system embedded as a safety component of an already-regulated product (Annex I: machinery, medical devices, toys, lifts, radio equipment). In practice, Luxembourg manufacturers still confuse product compliance (CE marking, Machinery Directive 2006/42/EC, MDR 2017/745) with AI compliance, assuming a single technical file suffices. The trap: market surveillance (ILNAS for products, EU AI Office for GPAI models, and the Luxembourg AI authority yet to be designated) will require two articulated files, and the absence of an AI risk analysis at the level of the complete product blocks market placement.
The concrete test to qualify an AI safety component
- Does the AI system perform a safety function (obstacle detection, emergency stop, vital diagnosis) or does its failure endanger health or safety? If yes, Article 6(1) applies.
- Is the host product covered by the harmonisation legislation listed in Annex I? Verify case by case: a collaborative robot (cobot) in manufacturing falls under the Machinery Directive; a diagnostic aid falls under the MDR.
- Can AI failure degrade the safety of the product as a whole, even if the AI is not strictly a safety component? Recital 47 broadens vigilance to the AI's contribution to overall risk.
- Is there third-party conformity assessment (notified body) on the host product? If yes, it must now integrate the AI dimension.
- Does the robot or device operate in a complex environment (personal care, hospital, shared workshop with human operators)? Recital 47 explicitly cites these cases as priorities.
How Luxgap automates this risk
Our Luxgap Safety-Critical AI Mapper resolves the product/AI duality by automatically mapping your embedded AI systems and cross-referencing each component with applicable harmonisation legislation (AI Act Annex I, MDR, Machinery Directive, RED, toys). The tool ingests your technical bills of materials from Odoo Manufacturing, SAP PLM or Siemens Teamcenter, identifies AI functions through firmware and specification analysis, and produces an enforceable Article 6(1) qualification verdict.
- Automatically detects each AI module embedded in your products from connected BOMs, Git repositories and technical specifications.
- Classifies each component as safety component, risk-contributing or neutral according to the grid of Recital 47 and Article 6.
- Cross-references with ILNAS databases and the list of notified bodies to identify the required third-party conformity assessment.
- Generates a pre-filled AI technical file (Article 11, Annex IV) articulated with the existing product file, avoiding duplicate documentation.
- Alerts in real time when a software update modifies the functional scope of an AI component and triggers a conformity reassessment.
- Produces a time-stamped PDF report, enforceable during market surveillance inspections, demonstrating control of the combined product-AI risk.
Available as a complement to a Luxgap CISO mandate or as a dedicated SaaS module depending on your industrial scope. Request a personalised quote and our teams will prepare a demonstration on your real products, with a free white audit within 48h to measure your exposure before any commitment.