On 26 March 2026, the European Parliament adopted amendments to a proposed regulation intended to simplify the implementation of EU rules on artificial intelligence (“Digital Omnibus on AI”), amending the EU AI Act (Regulation (EU) 2024/1689). The adopted text states the file was referred back for interinstitutional negotiations under the ordinary legislative procedure (first reading).
Selected points highlighted in the amendments
- AI literacy (Article 4): the approach is adjusted to place an explicit obligation on providers and deployers to take measures supporting AI literacy for staff and persons operating AI on their behalf, alongside a requirement for Commission guidance on practical implementation.
- Implementation timing (Article 113): the amendments include a proposal to postpone the application of specific obligations for high‑risk AI systems due to delayed availability of harmonized standards and guidance. For Annex I high‑risk AI products (including medical devices (MDR) and IVDs (IVDR) the amended text proposes a new application date of 02 August 2028. For Annex III high‑risk AI products (which may include some medical devices (MDR) or IVDs (IVDR) the amended text proposes a new application date of 02 December 2027.
- Extended Support for Small Mid‑Caps (SMCs) (Article 63): The Parliament extends proportionality measures (previously designed for SMEs) to Small Mid‑Cap Enterprises (SMCs) as well. SMCs would now benefit from similar support mechanisms to reduce administrative burden and ensure proportionate application of the AI Act.
- Structural Change: Shift from Annex I Section A → Section B – Annex I (Amendment 44) – A major restructuring removes Annex I Section A entirely, with all legislation previously listed under Section A moved to Section B, including the MDR and IVDR. Implications of the Structural Change:
- Sectoral legislation becomes the primary conformity pathway – For products such as medical devices and IVDs, sectoral conformity assessment under MDR/IVDR becomes the main assessment route for AI systems integrated into those products.
- Additional AI Act requirements apply only where relevant – Instead of a combined assessment under both the AI Act and the sectoral legislation, only relevant AI Act provisions apply directly—reducing overlap, administrative burden, and legal uncertainty for manufacturers.
Note: this is an adopted European Parliament position at first reading and is subject to further negotiations before any final legal text is agreed.
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