Today, the European Commission released a new proposal to amend the AI Act, introducing changes and clarifications that are particularly relevant for regulated sectors and for companies developing AI solutions integrated into medical devices or other regulated products. Key highlights include:
- Single CE marking process (MDR + AI Act)
The proposal confirms the intention to establish a unified conformity assessment pathway. The Commission suggests explicitly adding it to the legal text so that Notified Bodies can apply a combined MDR + AI Act CE-marking process and avoid duplication. - Simplified QMS requirements for startups and SMEs
The Commission proposes more proportionate Quality Management System requirements, so startups and SMEs do not need to meet every QMS obligation at the same level as larger companies. - Reduced Technical Documentation requirements for startups and SMEs
Aligned with the QMS simplifications, the amendment proposes lighter Technical Documentation requirements for smaller organisations. - Resolution of the conflict with GDPR
The amendment addresses the previous tensions between the AI Act and the GDPR. It introduces exceptions allowing the use of personal data when necessary to prevent bias or to train AI models, avoiding inconsistency between the two regulations. - Updated timelines
The previous application date of August 2026 is no longer valid. Implementation of high-risk AI requirements will now depend on the availability of harmonised standards, with new outer deadlines:
2 December 2027 → Annex III high-risk use cases
2 August 2028 → High-risk AI embedded in regulated products
The Commission may choose to bring these dates forward if it considers that “adequate compliance measures” exist, although the criteria remain unclear, creating some uncertainty for companies.
Once triggered, organisations would have six months (Annex III) or twelve months (product-integrated systems) to comply.
Read the full proposal text here:
https://digital-strategy.ec.europa.eu/en/library/digital-omnibus-ai-regulation-proposal
Need help? Contact us: [email protected]
