For the legally compliant provision of your high-risk AI systems in the EU – even without your own establishment
The EU AI Act (Regulation (EU) 2024/1689) establishes a risk-based legal framework for artificial intelligence in the EU. High-risk AI systems are subject to particularly stringent requirements, including those relating to risk management, data quality, transparency, technical documentation, human oversight and robustness.
High-risk systems include, for example, AI solutions in areas such as critical infrastructure, employment, creditworthiness checks, biometric identification or certain systems in public administration.
The following also applies to providers not established in the EU who make such high-risk AI systems available in the EU:
- The provider is established in a third country,
- wishes to make high-risk AI systems available on the EU market, and
- these systems fall within the scope of the AI Act.
In such cases, in accordance with Article 22 of the AI Act, they must appoint an authorised representative in the EU before making the high-risk AI systems available. This representative acts as the official point of contact for market surveillance and supervisory authorities and assists in ensuring compliance with the provider’s obligations.
Our role as your representative
Our experts in information security, AI regulation and compliance will act as your authorised representative in accordance with Article 22 of the AI Act and ensure that requirements and enquiries are handled in a coordinated, timely manner across the EU and in your best interests.
Among other things, we offer you:
- Acting as the official point of contact in the EU for market surveillance authorities and other competent bodies through our subsidiary Swiss Infosec (Deutschland) GmbH, based in Berlin, Germany.
- Receipt, coordination and forwarding of official orders, requests for information, measures and queries regarding your high-risk AI systems.
- Support in ensuring the availability of technical documentation and the EU Declaration of Conformity, so that these are complete and up to date when requested by the authorities.
- Assistance in coordinating corrective and risk mitigation measures (e.g. recalls, deactivation, updates) if a system is non-compliant or a risk exists.
- Pragmatic recommendations for action to implement key obligations for high-risk providers (risk management, monitoring, post-market surveillance, reporting of serious incidents, etc.).
- Support in aligning AI Act requirements with existing frameworks such as ISO 27001, ISO 42001, GDPR, NIS-2 or industry-specific standards.
This allows you to maintain your focus on the development, operation and scaling of your AI solutions. We take care of the operational implementation of the representative role and structured communication with the authorities.
Why choose Swiss Infosec as your representative under Article 22 of the AI Act?
- Combined expertise in AI regulation, data protection and information security, with a focus on the EU AI Act and related regulations.
- Practical, risk-oriented advice rather than purely formal checklist compliance.
- In-depth understanding of high-risk use cases (e.g. HR systems, scoring applications, critical infrastructure, financial and public sector environments).
- Structured process models for implementing AI Act-compliant processes across the entire lifecycle of high-risk systems (design, development, deployment, operation, monitoring).
- Clear lines of responsibility and streamlined processes – from the initial assessment and ongoing representation to support during market surveillance and enforcement proceedings.
Our goal: to ensure AI Act compliance for your high-risk AI systems in a way that allows you to remain legally compliant whilst continuing to innovate.
Next steps
Contact us for a no-obligation initial consultation. Together, we will clarify:
- Whether your AI solution is classified as a high-risk AI system within the meaning of the AI Act,
- what obligations you have as a provider, and
- how we can efficiently integrate the role of authorised representative for your high-risk AI systems into your existing governance, compliance and development processes.
Let us take care of the role of authorised representative for your high-risk AI systems, so that you can offer your AI solutions on the EU market in a secure, trustworthy and legally compliant manner.