# Reading the EU AI Act instead of leaving

Canonical page: https://cliniatlas.com/blog/eu-ai-act-clinical-evidence-tools/
Published: 2026-07-09

Medical AI regulation starts with intended purpose and actual functionality. Here is how CliniAtlas defines its current evidence-review scope.

OpenEvidence cited regulatory uncertainty, including the EU Artificial Intelligence Act, when it withdrew access from the EU and UK. The episode sharpened a real question for every medical-AI team operating in Europe: what exactly is the product intended to do?

That question cannot be answered by a disclaimer alone. Under the EU Medical Device Regulation, software classification depends on intended purpose and functionality. Rule 11 specifically addresses software that provides information used for diagnostic or therapeutic decisions.

## The boundary CliniAtlas uses today

CliniAtlas is currently intended for literature search, education, and professional evidence review. It is not intended for diagnosis, treatment selection, triage, monitoring, prognosis, or patient-specific clinical decision-making.

The product reinforces that scope in its interface and synthesis instructions. When a prompt contains a concrete patient scenario, the safety layer does not make a recommendation for that individual. It reframes the task as a general review of what retrieved guidelines and studies report for similar characteristics.

> This product boundary is an engineering and intended-use decision. It is not a legal determination, medical-device certification, or a claim that wording alone decides regulatory status.

## Why feature discipline matters

Patient-specific dose calculators, treatment rankings, differential diagnosis generators, and monitoring recommendations can materially change a product's intended purpose and risk profile. Those capabilities may be legitimate future products, but they require a deliberate regulatory and clinical-development path rather than incremental feature drift.

## Infrastructure and content boundaries

CliniAtlas hosts its application, model inference, and stored service data in AWS eu-central-1. Retrieval queries are sent on demand to public source APIs such as PubMed and Europe PMC. The source-licensing register distinguishes metadata, open-access full text, curated registries, and links to official documents; the product does not claim rights to redistribute paywalled text.

Regulation does make product decisions more explicit. For a European evidence tool, that pressure can be productive: define the use case, document the limits, measure the system, and avoid claiming functions that have not been built or validated.

## Sources and further reading

- EUR-Lex: Regulation (EU) 2024/1689, the Artificial Intelligence Act: https://eur-lex.europa.eu/eli/reg/2024/1689/oj
- EUR-Lex: Regulation (EU) 2017/745, the Medical Device Regulation: https://eur-lex.europa.eu/eli/reg/2017/745/oj
- The Lancet Regional Health - Europe: regulatory certainty and OpenEvidence geoblocking: https://pmc.ncbi.nlm.nih.gov/articles/PMC13226252/

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CliniAtlas is an EU-hosted clinical evidence search platform for verified
healthcare professionals, built in Split, Croatia, with the University of
Split School of Medicine. Free for verified clinicians and students:
https://cliniatlas.com/

For literature search, education, and professional evidence review only.
Not for diagnosis, treatment selection, triage, monitoring, prognosis, or
patient-specific clinical decision-making.