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 the product with digital elements following its placing on the market, which affects the compliance of the product with digital elements with the essential cybersecurity requirements set out in Part I of Annex I or which results in a modification to the intended purpose for which the product with digital elements 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 means Union legislation listed in Annex I to Regulation (EU) 2019/1020 and any other Union legislation harmonising the conditions for the marketing of products to which that Regulation applies; 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 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 means any government or other public administration entity, including national central banks. 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, point (1)(c), of Regulation (EU) No 1025/2012; and common specifications that are referred to in Articles 40 and 41, or of those harmonised standards means a harmonised standard as defined in Article 2, point (1)(c), of Regulation (EU) No 1025/2012; or technical specifications means a technical specification as defined in Article 2, point (4), of Regulation (EU) No 1025/2012; that are set out pursuant to Union harmonisation law.

    1. At the request of the Member States or the AI Office, or on its own initiative, the Commission shall update guidelines previously adopted when deemed necessary.

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