Route 1: products, safety components, and Annex I

Lesson 2 of 5 in High-Risk Classification: Art 6, Annexes I & III, and the Filter.

Route 1 grafts the AI Act onto forty years of EU product-safety law — the New Legislative Framework world of CE-marked machines, toys, and medical devices. The test in Art 6(1) has two cumulative conditions, and both must hold:

  1. The AI system is itself a product, or is a safety component of a product, covered by the Union harmonisation legislation listed in Annex I; and
  2. That product must undergo third-party conformity assessment under that legislation.

Condition 2 is the one people forget. Plenty of machinery self-certifies; a safety component inside a self-certified product does not enter high-risk through Route 1. The route only opens where a notified body was already going to look at the product.

Run the definition against a car. The AI that decides when emergency braking engages: failure endangers life — safety component. The AI running the infotainment playlist: failure annoys you — not a safety component. Same vehicle, same supplier, opposite classifications. The question is never where does the AI live but what happens when it fails.

Annex I splits into two sections, and the split matters more than it looks:

Section A — full regime

The classic NLF product laws: machinery, toys, recreational craft, lifts, equipment for explosive atmospheres, radio equipment, pressure equipment, cableway installations, personal protective equipment, gas appliances, medical devices, and in-vitro diagnostics.

AI entering high-risk through a Section A product gets the full Chapter III treatment — Arts 8–15 requirements, provider obligations, the works — but conformity assessment is embedded in the sectoral procedure (Art 43(3)): one notified body, one integrated assessment, one set of technical documentation covering both regimes (Art 11(2)). A radiology AI under the Medical Device Regulation is the canonical example: MDR notified body, AI Act requirements folded in.

Section B — sectoral delegation

The heavy transport regimes: civil aviation and aviation security, two- and three-wheel vehicles, agricultural and forestry vehicles, marine equipment, rail interoperability, and motor vehicles.

Here the AI Act mostly steps back. Under Art 2(2), only Art 6(1) and the amendment articles apply directly — the substantive requirements reach these products only as the sectoral legislators integrate them into their own type-approval and airworthiness rules. Reason: you do not bolt a horizontal regime onto aviation certification; you feed it in through the aviation rulebook. Practical consequence: if you build flight-control AI, your operative rulebook is EASA’s, informed by the AI Act’s essential requirements.

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