An initial classification in a few questions

Find out in a few questions whether your medical AI is likely high-risk under the EU AI Act and which duties roughly apply, indicative, not legally binding.

The EU AI Act classifies many medical AI systems as high-risk, especially when they fall under MDR or IVDR as a medical device or as a safety component and at the same time influence diagnosis, triage or the clinical decision. The high-risk duties bring risk management, data governance, technical documentation, human oversight and conformity assessment.

This self-check does not replace a legal review. It gives you a first, honest tendency and a starting point for the conversation. All answers stay in your browser; no input is transmitted.

Is your medical AI likely high-risk?

Answer every question with yes or no. You receive an instant, indicative classification together with the next steps.

Does your system fall under the MDR or IVDR as a medical device or as a safety component of a medical device? Yes No

Is the system used for diagnosis, triage or clinical decision support? Yes No

Does the system's output influence treatment decisions about natural persons? Yes No

Is the system placed on the EU market or used for patients in the EU? Yes No

Is the output relied upon without a qualified person meaningfully reviewing and being able to override it? Yes No

What comes after the self-check?

We turn the indicative tendency into a solid, documented classification, legally led and tailored to your concrete use case.

The AI Governance Check from CHF 3'900 is the clean next step: we review your system's classification on a case-by-case basis, map the EU AI Act duties and the interlock with MDR or IVDR, and deliver a prioritised, board-ready roadmap with traceable documentation.

If you need ongoing support rather than a one-off assessment, our AI Officer from CHF 500 per month takes over continuous AI governance: maintaining your AI inventory, keeping policies and evidence current, and accompanying new models and use cases before they go live.

Both are legally led: where a SIDD lawyer advises in a legal capacity, your information may be covered by professional secrecy under Art. 321 of the Swiss Criminal Code. We clarify the exact scope per mandate.

Why SIDD for the EU AI Act classification

Classifying medical AI is first a legal question. That is exactly where our focus lies.

Classification is a legal question

Whether a system is high-risk turns on the legal terms of the EU AI Act and its interplay with MDR and IVDR. The classification is led by doctorate-level lawyers with CIPP/E, backed by an in-house technical team, not just a tool.

AI governance depth

With three dedicated AI services, AI Governance Check, AI Officer and AI Security, we cover the EU AI Act from initial classification through ongoing governance to testing LLM and agent systems.

One documentation, two regimes

We produce risk management, technical documentation, human oversight and data governance once, interlocked for the EU AI Act and for MDR or IVDR, instead of twice in parallel.

Swiss professional secrecy

Where a SIDD lawyer advises in a legal capacity, your information may be covered by professional secrecy under Art. 321 of the Swiss Criminal Code, in addition to contractual confidentiality. We clarify the exact scope per mandate.

Multilingual & independent

We advise in German, French and English, relevant for French-speaking Switzerland and EU parent companies. Because we do not sell an in-house SOC, our recommendations stay independent.

Fixed-fee entry, quick to start

You start with the AI Governance Check from CHF 3'900 and a board-ready roadmap; for ongoing support the AI Officer from CHF 500 per month takes over AI governance, without creating a full-time role.

EU AI Act triage for medical AI