The first rules under Regulation ( EU) 2024/1689, the EU Artificial Intelligence Act (EU AI Act) came into effect on 2 February. These include the AI system definition, AI literacy requirements, and a set of prohibited AI use cases that pose unacceptable risks in the EU. The Commission plans to publish guidelines on AI system definition, release a repository of AI literacy practices, and issue guidance on prohibited AI practices to assist with compliance. Additionally, the Commission has launched initiatives to support AI innovation, including an AI innovation package for startups and SMEs, and upcoming AI Factories to provide computing resources for AI development.

EU analysis: Theresa Ehlen and Lutz Riede, partners; Laéna Bouafy, senior associate; Verena Kirchmair, associate; Julia Utzerath, senior knowledge lawyer and John-Markus Maddaloni, associate of Freshfields, consider the European Commission’s Guidelines on the scope of obligations for general-purpose AI (GPAI) models, published on 18 July 2025.

MLex: An early draft of a document on the interplay between the EU AI Act and medical device regulations discusses questions that are bound to arise on how the AI law’s requirements will interact with product safety rules, notably in terms of post-market monitoring, conformity assessment procedures and real-world testing.

This Practice Note is intended to provide an overview of key considerations for employers under Regulation (EU) 2024/1689, the EU Artificial Intelligence (AI) Act (EU AI Act). It provides key information regarding its scope, risk-classification approach, obligations and how these might apply in the employment context. For more information on the EU AI Act, see Practice Notes: • The EU AI Act • The EU AI Act—snapshot • EU AI Act—literacy rules • EU AI Act—general purpose AI models • Artificial intelligence in the EU—the key legal issues Background and context The EU AI Act introduces a comprehensive legal framework regulating the development, placing on the market, putting into service, and use of AI systems in the EU. Its purpose is to promote the uptake of human centric and trustworthy AI while protecting health, safety and fundamental rights, protect against

General Purpose AI (GPAI) models are subject to specific rules under the EU AI Act to ensure that these models are safe and trustworthy. This Practice Note covers the definition of GPAI models, the criteria for considering a GPAI model with systemic risk, the obligations imposed on providers of GPAI models, the exemption applicable to open-source GPAI models and the enforcement of the rules for GPAI models. It covers the EU AI Act rules but also the guidelines, code of practice, and templates published by the Commission to complement the Act. For more information on the EU AI Act in general, see Practice Notes: The EU AI Act—snapshot, The EU AI Act and Checklist: Requirements under the EU AI Act—checklist. For a list of all AI resources, see Practice Note: Artificial intelligence (AI) resource kit. Legislation and guidance Chapter V of the EU AI Act GPAI models are regulated under Chapter V of the EU AI Act. Recital 97 of the EU AI Act clarifies that GPAI models require a specific definition for legal certainty

TMT analysis: The EU’s Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. Once the (staggered) implementation period expires, providers of AI systems (especially those that are considered ‘high-risk AI systems’) will have to comply with a wide range of legal requirements. One of the key instruments for implementing these requirements will be standards. Laura Knoke, Lutz Riede, Christoph Werkmeister and Theresa Ehlen, partners and Philipp Roos, Verena Kirchmair and Yannick Chatard, associates at Freshfields Bruckhaus Deringer explore whether and how ISO 42001 may be utilised to meet some of the key AI Act requirements.

This Practice Note provides an overview of the AI literacy requirements in the context of Regulation (EU) 2024/1689, the EU Artificial Intelligence Act or EU AI Act, as amended by Regulation (EU) 2026/1744 amending Regulation (EU) 2024/1689, Regulation (EU) 2018/1139 and Regulation (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI). It covers: • What is AI Literacy? • AI Literacy under the EU AI Act • Regulatory guidance and emerging practice • The key legal considerations • Failure to comply with the AI literacy obligation • Practical techniques to support AI Literacy For more information on AI, see Practice Notes: • Artificial intelligence and machine learning—an introduction to the technology • Artificial intelligence—data protection in the EU • Artificial intelligence in the EU—the key legal issues • The EU AI Act • Requirements under the EU AI Act—checklist, and • Contractual considerations for

Regulation (EU) 2024/1689, the EU AI Act introduces a harmonised legal framework for the regulation of AI technology across the EU. Under Article 5 of the EU AI Act, AI practices deemed to pose unacceptable risks to EU values and fundamental rights are prohibited. Regulation (EU) 2026/1744 amending Regulation (EU) 2024/1689, Regulation (EU) 2018/1139 and Regulation (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI) further completed the list of prohibited practices and added two new prohibited practices. This Practice Note examines each of the prohibited practices under Article 5, outlines the related enforcement and liability implications, and provides guidance on relevant contractual considerations. For more information on the EU AI Act in general, see Practice Notes: The EU AI Act—snapshot, The EU AI Act  and Checklist: Requirements under the EU AI Act—checklist. For a list of all AI resources, see Practice Note: Artificial intelligence (AI) resource kit. Background Regulation (EU) 2024/1689, the EU Artificial Intelligence Act or EU AI Act introduces a harmonised legal framework for the regulation of AI technology

MLex: Proposals in the EU's AI Act to regulate foundation models and general purpose AI systems have sparked concerns from a group of technology company associations, including BSA, The Software Alliance and the Computer & Communications Industry Association. The groups said that any measurement to establish whether an AI model is ‘highly capable’ or ‘high impact’ should be based on a ‘thorough assessment’ and a ‘consultation with AI industry, academic and civil society experts'. They are also concerned about proposals to introduce additional requirements for the use of copyrighted data to train AI systems.

The European Commission's EU AI Office has created a living repository of AI literacy practices to support the implementation of Article 4 of Regulation (EU) 2024/1689 (AI Act), which came into effect on 2 February 2025. The repository compiles examples from AI Pact organisations, categorising them by implementation status. Whilst not guaranteeing compliance, the initiative aims to foster learning and exchange among AI providers and deployers. The EU AI Office emphasises that this forms part of its broader efforts to support Article 4 implementation, with further developments to be discussed in an upcoming webinar.

The European Commission has launched a package of measures to support European startups and small and medium-sized enterprises (SMEs) with the development of artificial intelligence (AI). The Commission's measures follow the political agreement reached in December 2023 on the EU AI Act and put into practice the commitment made during Von der Leyen's speech at the 2023 State of the EU debate to support AI startups and innovation. It also includes a proposed provision of privileged access to supercomputers to AI startups.

The Industry Group of Notified Bodies (IG-NB) and Team NB have collaboratively released a questionnaire addressing artificial intelligence in medical devices. This document, developed in response to MDGG 2022-14 requests, primarily focuses on Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation (IVDR)), as well as the Medical Device Software (MDSW) guidance from the Medical Device Coordination Group (MDCG). While the questionnaire does not fully incorporate the specific requirements of the EU AI Act (Regulation (EU) 2024/1689), it acknowledges the significant overlap between this regulation and existing regulatory frameworks for software and AI in medical devices. A comprehensive revision is planned to fully integrate the AI Regulation's requirements in the future.