Article 96 Guidelines from the Commission on the implementation of this Regulation


    1. The Commission shall develop guidelines on the practical implementation of this Regulation, and in particular on:

      1. the application of the requirements and obligations referred to in Articles 8 to 15 and in Article 25;

      2. the prohibited practices referred to in Article 5;

      3. the practical implementation of the provisions related to substantial modification means a change to an AI system after its placing on the market or putting into service which is not foreseen or planned in the initial conformity assessment carried out by the provider and as a result of which the compliance of the AI system with the requirements set out in Chapter III, Section 2 is affected or results in a modification to the intended purpose for which the AI system has been assessed;;

      4. the practical implementation of transparency obligations laid down in Article 50;

      5. detailed information on the relationship of this Regulation with the Union harmonisation legislation listed in Annex I, as well as with other relevant Union law, including as regards consistency in their enforcement;

      6. the application of the definition of an AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; as set out in Article 3, point (1).

    2. When issuing such guidelines, the Commission shall pay particular attention to the needs of SMEs including start-ups, of local public authorities and of the sectors most likely to be affected by this Regulation.

    3. The guidelines referred to in the first subparagraph of this paragraph shall take due account of the generally acknowledged state of the art on AI, as well as of relevant harmonised standards means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012; and common specifications means a set of technical specifications as defined in Article 2, point (4) of Regulation (EU) No 1025/2012, providing means to comply with certain requirements established under this Regulation; that are referred to in Articles 40 and 41, or of those harmonised standards means a harmonised standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012; or technical specifications that are set out pursuant to Union harmonisation law.

    1. At the request of the Member States or the AI Office means the Commission’s function of contributing to the implementation, monitoring and supervision of AI systems and general-purpose AI models, and AI governance, provided for in Commission Decision of 24 January 2024; references in this Regulation to the AI Office shall be construed as references to the Commission;, or on its own initiative, the Commission shall update guidelines previously adopted when deemed necessary.

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