Before assessing whether a system should be classified as high-risk under Article 6 AI Act, two general points must first be considered: whether the system qualifies as an AI system within the meaning of the AI Act, and what its intended purpose is as specified by the provider.
Quick classification checklist
1. Is the system an AI system?
Before a system can be classified as high-risk, it must qualify as an AI system within the meaning of Article 3(1) AI Act. Not every software application or automated decision-making system falls within the scope of the AI Act. See the relevant section of the draft Guidelines and the Commission Guidelines on the definition of an AI system.
2. What is the intended purpose of the AI system?
The intended purpose of an AI system is relevant for its classification as high-risk under Article 6 AI Act. Under Article 3(12) AI Act, intended purpose means the use for which the system is intended by the provider, including the specific context and conditions of use, as described in the information and documentation supplied by the provider. For further explanation, see the relevant section of the draft Guidelines.
3. Does the Annex I route apply?
Article 6(1) AI Act applies to AI systems intended to be used as a safety component of a product or that are products covered by the Union harmonisation legislation listed in Annex I AI Act. In this case, see High-risk AI in regulated products.
4. Does the Annex III route apply?
Check whether the AI system falls within one of the high-risk use cases in the sensitive areas listed in Annex III. For this route, see High-risk use cases in certain sensitive areas.
5. If Annex III applies, does the Article 6(3) filter apply?
Check whether the system should nevertheless not be classified as high-risk under the filter.
6. Is there a relevant transitional rule?
Check whether the system was placed on the market or put into service before the relevant AI Act rules apply.