This series examines AI regulation in Switzerland and the EU. Topics include general-purpose models, medical AI, pharmaceutical research and the Digital Omnibus changes to AI Act deadlines, with comparisons between Swiss and EU approaches.
These articles provide general information and are not legal advice.
For AI devices that need a notified body, the AI Act adds high-risk duties to the MDR, and the Swiss medical devices ordinance (MepV) has no AI-specific provisions. The FDA allows changes pre-specified in an authorized change control plan, but no framework yet admits continuous learning.
AI built and used purely for research can sit outside the AI Act, but the exclusion ends once a system is tested on patients or placed on the market. High-risk duties then apply from August 2026 or, for AI in medical devices, from August 2027.
AI-enabled medical software that needs a notified body under the MDR is high-risk through the product route in Annex I AI Act rather than Annex III AI Act, so its obligations attach in 2027 and are assessed within 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.
Switzerland forgoes a horizontal AI statute: the Federal Council plans to ratify the Council of Europe AI Convention and amend sector laws, with a consultation draft due by the end of 2026, while Swiss data protection law already governs AI. US firms active in both markets work under two frameworks.
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.
An AI-enabled device sold from Switzerland into the EU answers to two cybersecurity regimes that measure different things: the MDR secures the device in its IT environment, the AI Act the model against manipulation. Switzerland adds a 24-hour reporting clock.
EU AI Act chatbot and content-label duties depend on role, output and exceptions. Pharma and MedTech communications are subject to medicines and device ad law.
The Digital Omnibus changed the AI literacy duty without removing it. Enforcement depends on the operator's role, while data-protection, cybersecurity and sectoral training rules can govern the same staff.
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