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

Given the complexity of high-risk AI systems and the risks that are associated with them, it is important to develop an adequate conformity assessment procedure for high-risk AI systems involving notified bodies, so-called third party conformity assessment. However, given the current experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI systems other than those related to products. Therefore, the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems intended to be used for biometrics.

[Previous version]

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

Given the complexity of high-risk AI systems and the risks that are associated to them, it is important to develop an adequate system of conformity assessment procedure for high- risk AI systems involving notified bodies, so called third party conformity assessment. However, given the current experience of professional pre-market certifiers in the field of product safety and the different nature of risks involved, it is appropriate to limit, at least in an initial phase of application of this Regulation, the scope of application of third-party conformity assessment for high-risk AI systems other than those related to products. Therefore, the conformity assessment of such systems should be carried out as a general rule by the provider under its own responsibility, with the only exception of AI systems intended to be used for biometrics.

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