**Target:** Proposal for a regulation — Recital 31

## Text proposed by the Commission

(31) The classification of an AI system as high-risk pursuant to this Regulation should not necessarily mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered ‘high-risk’ under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is notably the case for Regulation (EU) 2017/745 of the European Parliament and of the Council ( 47 ) and Regulation (EU) 2017/746 of the European Parliament and of the Council ( 48 ) , where a third-party conformity assessment is provided for medium-risk and high-risk products.

(31)

(31)

## Amendment of the European Parliament

(31) The classification of an AI system as high-risk pursuant to this Regulation should not mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered ‘high-risk’ under the criteria established in the relevant Union harmonisation law that applies to the product. This is notably the case for Regulation (EU) 2017/745 of the European Parliament and of the Council ( 47 ) and Regulation (EU) 2017/746 of the European Parliament and of the Council ( 48 ) , where a third-party conformity assessment is provided for medium-risk and high-risk products.

The classification of an AI system as high-risk pursuant to this Regulation should not necessarily mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered ‘high-risk’ under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is notably the case for Regulation (EU) 2017/745 of the European Parliament and of the Council ( 47 ) and Regulation (EU) 2017/746 of the European Parliament and of the Council ( 48 ) , where a third-party conformity assessment is provided for medium-risk and high-risk products.

The classification of an AI system as high-risk pursuant to this Regulation should not mean that the product whose safety component is the AI system, or the AI system itself as a product, is considered ‘high-risk’ under the criteria established in the relevant Union harmonisation law that applies to the product. This is notably the case for Regulation (EU) 2017/745 of the European Parliament and of the Council ( 47 ) and Regulation (EU) 2017/746 of the European Parliament and of the Council ( 48 ) , where a third-party conformity assessment is provided for medium-risk and high-risk products.