The EU AI Act binds any provider whose system reaches the Union market, wherever it is established, and its obligations arrive on a staggered clock: the general-purpose model duties have applied since August 2025, the Commission's enforcement powers follow in August 2026, and the high-risk regime for AI inside medical devices and pharmaceutical research sits behind the Digital Omnibus deferral. For a US company the practical questions are which route to high-risk status a product takes, how the AI Act layer is assessed inside an existing MDR conformity assessment, and what Switzerland's sector-by-sector approach, which forgoes a horizontal statute, does to a compliance program built for the EU. The analyses below take those questions one at a time, from foundation models to the German pharma laboratory.
6 insights · latest June 2026
AI-enabled medical software reaches high-risk status through the AI Act's Annex I product route rather than Annex III, so obligations attach in 2027 and are assessed as a second layer inside MDR conformity assessment.
The AI Act's obligations for general-purpose AI models have bound providers, wherever established, since 2 August 2025; the Commission's power to investigate and fine arrives 2 August 2026, a date the high-risk deferral did not move.
High-risk AI in pharma R&D faces phased EU conformity assessment in 2026 and 2027. Dual MDR/AI Act compliance for US firms in Germany compounds the challenge.
The EU Digital Omnibus moves at two speeds: an adopted AI Act track defers high-risk deadlines to December 2027 and August 2028, while the GDPR, ePrivacy and Data Act rewrite remains an unagreed proposal.
Switzerland forgoes a horizontal AI statute, ratifying the Council of Europe AI Convention and amending sector law, with a consultation draft due by the end of 2026; the DSG already governs AI, splitting compliance for US firms.
Machine learning algorithms that evolve post-market challenge traditional regulatory frameworks built for static devices. What happens when your device learns after approval?
Counsel on this topic: EU AI Act compliance counsel.
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