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EU proposes simplification measures for the implementation of the AI Regulation 2024/1689

Date
November 26, 2025
Category

EU Regulations

Description

The EU AI Regulation 2024/1689 was published in the Official Journal on 12 July 2024.  The Regulation applies to all AI systems in the EU, including those used in medicines and medical devices.  The majority of the provisions in the Regulation were intended to apply from 2 August 2026.  

On 19 November 2025 the European Commission proposed targeted simplification measures to ensure timely, smooth, and proportionate implementation of certain of the AI Act’s provisions, see Digital Omnibus on AI Regulation Proposal | Shaping Europe’s digital future.  To address the implementation challenges, the Commission is proposing targeted simplification measures to ensure timely, smooth, and proportionate implementation of certain of the AI Act’s provisions.  The measures proposed include:

  • linking the implementation timeline of high-risk rules to the availability of standards or other support tools;
  • extending regulatory simplifications granted to small and medium-sized enterprises (SMEs) to small mid-caps (SMCs), including simplified technical documentation requirements and special consideration in the application of penalties;
  • requiring the Commission and the Member States to foster AI literacy instead enforcing unspecified obligation on providers and deployers of AI systems in this respect, while training obligations for high-risk deployers remain;
  • offering more flexibility in the post-market monitoring  by removing a prescription of a harmonised post-market monitoring plan;
  • reducing the registration burden for providers of AI systems that are used in high-risk areas but for which the provider has concluded that they are not high-risk as they are only used for narrow or procedural tasks;
  • Centralising oversight over a large number of AI systems built on general-purpose AI models or embedded in very large online platforms and very large search engines with the AI Office;
  • facilitating compliance with the data protection laws by allowing providers and deployers of all AI systems and models to process special categories of personal data for ensuring bias detection and correction, with the appropriate safeguards;
  • a broader use of AI regulatory sandboxes and real-world testing, that will benefit European key industries such as the automotive industry, and facilitating an EU-level AI regulatory sandbox which the AI Office will set up as from 2028;
  • targeted changes clarifying the interplay between the AI Act and other EU legislation and adjusting the AI Act’s procedures to improve its overall implementation and operation. 

As well as these legislative measures, the Commission is taking further measures to facilitate compliance with the AI Act and address the concerns raised by stakeholders.  Further practical application guidance is in preparation on the following:

  • the high-risk classification,
  • the reporting of serious incidents by providers of high-risk AI systems,
  • the high-risk requirements,
  • the obligations for providers and deployers of high-risk AI systems,
  • a template for the fundamental rights impact assessment,
  • the rules for responsibilities along the AI value chain,
  • the provisions related to substantial modification,
  • post-market monitoring of high-risk AI systems,
  • the elements of the quality management system which SMEs and SMCs may comply with,
  • the AI Act’s interplay with other Union legislation,
  • the competences and designation procedure for conformity assessment bodies to be designated under the AI Act.