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Updated on May 21st 2024 based on the version and article numbering approved by the EU Parliament on May 14th 2024.

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 to be high-risk under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is, in particular, the case for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party conformity assessment is provided for medium-risk and high-risk products.

[Previous version]

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

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 to be high-risk under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is, in particular, the case for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party conformity assessment is provided for medium-risk and high-risk products.

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

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 to be high-risk under the criteria established in the relevant Union harmonisation legislation that applies to the product. This is, in particular, the case for Regulations (EU) 2017/745 and (EU) 2017/746, where a third-party conformity assessment is provided for medium-risk and high-risk products.

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