On February 12, 2025, the Federal Council of Switzerland announced its long-awaited approach to artificial intelligence (AI) regulations. Instead of adopting comprehensive AI laws like the European Union, Switzerland will choose sector-specific frameworks and integrate AI considerations into existing laws rather than creating a standalone regulatory regime.
The Federal Council wants to use that possibility to regulate AI so that it can be used to strengthen Switzerland as a place of business and innovation. At the same time, the risks to society need to be kept as low as possible.
The Federal Council has decided to focus on the following parameters:
The Council of Europe’s AI Treaty is incorporated into Swiss law. It mainly applies to state actors. If legislative changes are required, they must be as sector-specific as possible. Only important areas related to fundamental rights, such as data protection, are subject to general cross-sectional regulations. In addition to the law, non-regular binding measures will be developed to support the implementation of the treaty. Measures may include self-disclosure agreements or industry solutions.
This decision is consistent with three important objectives.
It strengthens Switzerland’s position as an innovation hub. Protection of fundamental rights, including financial freedom. Strengthening public trust through AI.
Ensuring AI regulations does not curb innovation
The Swiss approach aims to balance regulatory oversight with innovation-friendly conditions. As Switzerland is improving its AI regulatory approach, several key challenges need to be addressed, including:
Avoid regulatory uncertainty: Companies can struggle with compliance if AI rules are not consistently applied across different sectors. Clear and harmonious guidance is essential. Preventing a “Swiss finish”: Switzerland has historically been linked with EU regulations in many sectors, and has sometimes added national requirements to bring about so-called “Swiss finish.” In the case of AI, Switzerland does not adopt EU AI laws and instead develops its own regulatory approach. Regulatory autonomy can provide flexibility, but there is a great risk of fragmentation. Divergence from the EU framework can create legal uncertainty and increase complexity for AI-driven medical technology developers, especially those operating across borders. To prevent unnecessary regulatory barriers, it is essential that Swiss regulations interoperate with international standards and promote access to global markets rather than isolating Swiss innovation through incompatible or overly strict requirements.
What it means for a Swiss life sciences company
The decision to regulate AI by sector rather than through a single legislative act has implications for life science companies. As AI increasingly shapes drug discovery, diagnosis, clinical decision-making, and digital therapy, regulatory clarity is essential. Swiss decision not to impose horizontal AI laws means compliance obligations are determined by sector-specific laws, including those governing medical devices, medicines and data protection.
For the pharmaceutical sector, where regulatory frameworks are heavily shaped by global standards such as international conferences on harmony guidelines and the “good practice” requirements, Swiss AI requirements could be determined by these established global frameworks already applied through Swiss legal referrals. AI applications such as drug development and manufacturing should be tailored to these internationally recognized requirements.
At MedTech, Swiss AI strategy presents another challenge. As highlighted in the divisional analysis that served as the basis for the decision of the Swiss Federal Council, Swiss Medic’s market surveillance activities are expected to be affected. Additionally, legislative changes to Swiss medical devices will be required based on current assessments.
However, while Swiss sectoral approach aims to provide regulatory flexibility, AI-powered medical devices must comply with the requirements of the EU’s Medical Device Regulation (MDR)/in vitro diagnostic regulations (IVDR). As long as Swiss companies are fully dependent on access to markets through the EU and certification by the European Notification Agency, their application to medical devices must meet the requirements of the EU AI Act.
Swiss AI and Digital Health Authority for Market Access
However, Switzerland has the opportunity to go beyond regulatory alignment and establish a true competitive advantage. By creating a dedicated AI and digital health regulator (“Swiss Competence Centre for Swiss Digital Health”), Switzerland can streamline approval for AI-driven healthcare solutions, providing faster, more predictable roads to market access. This reduces dependence on foreign notification agencies and positions Switzerland as the leading innovation hub for AI-powered MedTech.
Such institutions include:
It certifies AI-based medical technologies used in Switzerland and establishes structured regulatory pathways that ensure both safety and efficiency. It promotes a smoother transition from Swiss approval to EU and US compliance, and builds mutual recognition agreements with international regulators. It provides regulatory sandboxes for AI in life sciences, enabling controlled real-world testing prior to full approval, and promotes innovation while maintaining patient safety.
Switzerland has already evaluated ways to adapt its regulatory framework to enable US Food and Drug Administration (FDA)-approved medical devices to enter the Swiss market. Based on this approach, dedicated AI and digital health authorities, similar to the US model, can help AI-driven healthcare solutions benefit from a more efficient and predictable approval process, in line with a centralized market access privilege framework.
If Switzerland successfully integrates sector-specific AI regulations within a globally recognized approval framework, while still providing faster and independent market access routes, it can establish itself as a major hub for AI-driven life sciences and accelerate the path from Swiss approval to international adoption.
The road beyond AI in Switzerland’s life sciences
In conclusion, Switzerland’s decision to regulate AI through sector-specific rules rather than broad AI laws is a double-edged sword. On the one hand, it can provide an innovation-friendly environment aimed at enabling AI-driven life science companies to test, iterate and refine solutions more freely than regulated markets. Meanwhile, there is a greater compliance burden on companies that require them to navigate multiple legal frameworks while ensuring consistency with the EU, US and international AI governance models. Over the next few years, we will decide whether Swiss AI regulatory models will act as launchpads for global innovation or further complicate market access for Swiss innovative solutions.
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