European Union

ensure that the AI system’s output is interpretable by the provider and the user. (2023) source Unverified

2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified body. 3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider shall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply. For the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under those legal acts. (2025) source Unverified