Feature · Classification · Written by Yobel Tzegai · Last checked 9 October 2026

Is your AI system high-risk under Annex I?

It is when both conditions of Article 6(1) are met: the AI system is a safety component of a product, or is itself a product, covered by an act listed in Annex I, and that product must undergo a third-party conformity assessment. Complipath (complipath.io) asks the three questions behind those conditions and records your answers with the line they rest on.

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What the app says it does

Asks whether a system is a safety component of a product under the EU product laws listed in Annex I, and records your answers with the line of Annex I they rest on.

Illustration · not your dataSafety component or product? YesCovered by an act in Annex I? I don't knowOutcome Could not be decided · what to find out, written beside it

What you get

Three questions, Yes, No or I don't know, each shown with the exact words of Article 6(1) it asks about. Nothing is pre-selected.
The acts listed in Annex I, as amended by Regulation (EU) 2026/1744: Section A, point 1 (the machinery directive) is deleted. Section B gains point 21, Regulation (EU) 2023/1230 on machinery.
Where the product is covered, you can pick the act; for an act in Section B the record quotes Article 2(2) beside it.
I don't know is a real answer: the route is recorded as undecided, with what you would need to find out.
Every record names who made it and when, and says that Complipath has not verified it. A withdrawn record stays on file with the date it was withdrawn.

Where it is in the app

On each system's classification page, under the result, headed Article 6(1) — the Annex I route. The dashboard lists the systems that have not answered it yet.

The date that applies

The obligations in Chapter III, Sections 1, 2 and 3, other than Article 6(5), apply from 2 August 2028 to an AI system that is high-risk under Article 6(1) and Annex I, and from 2 December 2027 to one that is high-risk under Article 6(2) and Annex III (Article 113, third paragraph, point (c), as replaced by Regulation (EU) 2026/1744).

What it does not do

It does not change the risk class. The classification covers Annex III and Article 5, and an Annex I record stands beside it.
It does not derive the requirements that follow from Annex I. The record says on which route your answers put the system and from when Article 6(1) applies; the requirements list keeps its own dates.
It does not decide for you. The answers are yours, and the record says so.

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Questions

What does Article 6(1) require for a system to be high-risk?

Both of its conditions. The AI system is intended to be used as a safety component of a product, or is itself a product, covered by the Union harmonisation legislation listed in Annex I, and that product is required to undergo a third-party conformity assessment under that legislation before it is placed on the market or put into service.

What changed in Annex I in 2026?

Regulation (EU) 2026/1744 deleted point 1 of Section A and added point 21 to Section B: the machinery regulation, Regulation (EU) 2023/1230. For an AI system related to a product under an act in Section B, Article 2(2) as replaced limits which provisions of the AI Act apply, and the record quotes it.

Does my answer change the classification?

No. The classification in Complipath covers Annex III and Article 5, and your Annex I answers stand beside it as a record of the Article 6(1) route, with who answered and when. The record says that Complipath has not verified the answers, and it does not derive the requirements that follow.

Which plan includes it?

Starter, at €499 a month for up to 20 AI systems, and the trial: the app lists this feature for Starter. Prices exclude VAT. Your first system is free, with no end date. Growth and Scale are not available yet, and nothing on this page waits for either of them.