On 29 June 2026, the Council of the EU formally adopted the “Digital Omnibus on AI,” simplifying and streamlining key parts of the EU AI Act. This follows the European Parliament’s endorsement on 16 June, and the regulation will enter into force three days after publication in the Official Journal.
Key changes to track:
New timeline for high-risk AI obligations
Originally due to apply from 2 August 2026, high-risk AI system requirements are now delayed to:
→ 2 December 2027 for stand-alone high-risk AI systems
→ 2 August 2028 for high-risk AI systems embedded in products
New prohibited practice
A ban on AI systems that generate non-consensual sexual or intimate content, or CSAM, including so-called “nudifier” apps. This takes effect 2 December 2026.
Shorter transparency grace period
The window for providers to implement transparency solutions for AI-generated content (e.g. watermarking) has been cut from 6 to 3 months, with a new deadline of 2 December 2026.
Sandbox deadline pushed back
National AI regulatory sandboxes now have until 2 August 2027 to be established.
Interplay with sectoral legislation
Notably for our industry, the regulation introduces a mechanism to resolve overlaps between AI Act high-risk requirements and sector-specific rules, including medical devices. This should bring welcome clarity for manufacturers navigating both frameworks.
A wake-up call for medical device manufacturers: these extended deadlines are not a reason to wait. ISO 13485 alone will not get you there, and AI-based software devices are entering a new era of scrutiny. Standard MDR technical documentation will not suffice to demonstrate compliance with these evolving AI Act requirements. Manufacturers need to act now to update their QMS and technical files before the new deadlines hit.
Asphalion’s Digital Health and Biomedical Engineering team specializes in software-based medical devices and can help you bridge the gap between MDR and AI Act requirements, ensuring you comply in time and with confidence.
Get in touch with our team to assess your readiness! [email protected]
