On 11 March 2026, the European Parliament and the Council reached a major political agreement on amendments to the AI Act within the framework of the digital omnibus. This legislative package, launched by the European Commission in November 2025, aims to simplify and align several European digital regulations. Here is a breakdown of the concrete changes for businesses and AI system developers.
What is the Digital Omnibus?
On 19 November 2025, the European Commission launched an ambitious project to simplify European digital law. The principle: bundle amendments to the GDPR, NIS2, the Data Act and the AI Act into a single legislative package (omnibus). The stated objective is twofold: reduce the administrative burden on businesses and align regulatory timelines with the reality on the ground.
For the artificial intelligence component, the aim is to make the AI Act more workable, without weakening its fundamental objectives of protecting fundamental rights and ensuring safety. A balancing act: the regulation is not yet fully in force… but it is already (almost) being amended.
AI Act and Digital Omnibus: The 5 Key Changes
1. Extended Deadlines for High-Risk AI Systems
Compliance obligations for high-risk artificial intelligence systems (those listed in Annex III of the AI Act) are now conditional on the effective availability of harmonised technical standards from CEN-CENELEC, with a deadline set at December 2027.
This is a common-sense measure: compliance with standards that do not yet exist cannot be required. This pragmatic approach gives standardisation bodies time to finalise their work while providing AI system developers with a clear timeline.
2. Simplified Regime for Already Regulated Products
AI systems integrated into products subject to sectoral regulation — such as medical devices or industrial machinery — now benefit from simplified treatment. The objective is to avoid the accumulation of compliance regimes that could create contradictions or disproportionate burdens for manufacturers.
3. SME Exemptions Extended to Small Mid-Caps
The simplified regime initially reserved for SMEs is now extended to mid-sized companies with up to 750 employees and EUR 150 million in turnover. This broadening recognises that the AI Act compliance burden can prove disproportionate for companies that lack the resources of large technology groups.
4. Ban on Non-Consensual Sexual Deepfakes
A last-minute addition, secured by France, Spain, Germany and Slovakia, this amendment directly targets generative AI models capable of producing non-consensual sexual content or child sexual abuse material.
A legally noteworthy point: it is the technical capability of the system that is targeted, not merely the end use. This approach follows in the wake of scandals involving generative AI tools used to produce sexual images of real people without their consent. It sends a strong signal from the European legislator.
5. Simplified Registry for High-Risk Systems
A simplified registry is maintained for high-risk AI systems, offering a compromise between the requirement for traceability and the reduction of documentation burden. The idea is to preserve essential transparency without drowning operators in paperwork.
What Impact Does the AI Act Digital Omnibus Have on Businesses?
This political agreement on the AI Act within the framework of the digital omnibus confirms a trend: the European legislator is adjusting in real time, taking into account feedback from the field. The regulation remains the global benchmark for artificial intelligence regulation, but its practical arrangements are becoming more flexible.
For organisations already preparing for compliance, the message is clear: the fundamentals are not changing. The obligations regarding transparency, risk management, data governance and documentation remain the cornerstone of the AI Act. It is the deadlines and application thresholds that are evolving.
Next step: the formal committee vote is expected on 18 March 2026. We will publish a detailed analysis of the final text as soon as it is adopted.
Are you developing or deploying AI systems? Contact us for tailored support with your AI Act and digital omnibus compliance.