Regulation (EU) 2024/1689 («AI Act») does not apply only to companies established in the EU. Swiss firms can be directly affected under certain conditions — for example as a provider (Anbieter) that places systems on the market in the Union, or when the output (Ausgabe) of a system is used in the Union.
This page provides an orientation framework for exporters and SMEs with an EU nexus. It is not legal advice.
Territorial scope (Art. 2)
Under Art. 2(1), the Regulation applies inter alia to:
- providers that place on the market (Inverkehrbringen) AI systems (KI-System) or general-purpose AI models (KI-Modell mit allgemeinem Verwendungszweck, GPAI) in the Union or put into service (Inbetriebnahme) AI systems there — regardless of whether they are established in the Union or in a third country;
- deployers (Betreiber) of AI systems with an establishment or location in the Union;
- providers and deployers established or located in a third country, if the output generated by the system is used in the Union;
- importers, distributors, product manufacturers, authorised representatives, and affected persons in the Union.
For Swiss companies, two triggers are especially relevant in practice:
- Market access: You offer an AI system or GPAI model in the EU or put it into service there.
- Output use in the EU: The system also runs outside the EU, but results — e.g. predictions, content, recommendations, or decisions — are used in the Union.
Whether a purely Swiss deployment without EU output remains outside the AI Act depends on the concrete facts and should be assessed case by case.
Risk-based approach (overview)
The AI Act distinguishes inter alia:
- prohibited AI practices (Verbotene Praktiken im KI-Bereich);
- high-risk AI systems (Hochrisiko-KI-System) with extensive duties (including risk management, data quality, documentation, human oversight (menschliche Aufsicht));
- transparency obligations for certain systems (e.g. interaction with humans, deepfakes);
- rules for general-purpose AI models (GPAI), including additional duties for systemic risk.
The precise classification of your system determines the catalogue of duties — not the company seat alone.
Phased timeline
The AI Act applies in stages. Unchanged under Regulation (EU) 2024/1689:
- entry into force: 1 August 2024;
- first prohibitions and AI literacy (KI-Kompetenz) duties (Art. 4): from 2 February 2025;
- governance and GPAI duties: from 2 August 2025.
For high-risk duties there are currently two planning tracks:
- Current legal position (Regulation (EU) 2024/1689, as long as no amendment applies in the Official Journal): most high-risk duties from 2 August 2026; certain embedded high-risk systems until 2 August 2027.
- Digital Omnibus on AI (European Parliament 16 June 2026, Council 29 June 2026; entry into force three days after publication in the Official Journal, expected before 2 August 2026):
- standalone high-risk systems (Annex III): 2 December 2027;
- high-risk systems embedded in products (Annex I): 2 August 2028;
- end of the transitional period for transparency solutions (e.g. labelling of AI-generated content): 2 December 2026.
Until Official Journal publication, the current legal position remains formally decisive. Plan with both tracks and check the current Official Journal status.
Swiss providers with an EU market should map the stage applicable to their product class early.
What Swiss exporters should check
- Is the system or its output offered or used in the EU?
- What role do you have: provider, deployer, importer, distributor?
- Risk class and annex mapping (high-risk / prohibited / transparency / GPAI)?
- Does a provider without an EU establishment need an authorised representative in the Union?
- Documentation, quality management, and human oversight — even where Swiss DSG duties apply in parallel.
The AI Act and the Swiss DSG are different regimes. Both can be relevant at the same time.
Disclaimer
This page is informational and not legal advice. For EU market access, a case-by-case assessment is recommended (product, role, output use, deadlines).