This dossier is informational. It does not constitute legal or regulatory advice and does not replace official texts, Commission guidance, competent bodies or specialist advice.
Start from the official text and separate law from interpretation
The European artificial intelligence regulation is Regulation (EU) 2024/1689. For medical devices and in vitro diagnostic medical devices, the European Commission has also published a dedicated FAQ on the interplay between the AI Act, MDR and IVDR.
Themes we track for health projects
Classification
Understand why a system may fall into a high-risk category and identify associated sectoral legislation.
Data
Governance, quality, representativeness, traceability and documentation of data used for development and evaluation.
Documentation
Describe intended purpose, performance, limitations, testing, versions and assumptions in an operational form.
Robustness
Document performance, degradation conditions, risks and associated mitigation measures.
Human oversight
Define what users need to understand, monitor or be able to interrupt in the system's operation.
MDR/IVDR interplay
Avoid treating the AI Act as an isolated framework when the system is also subject to medical device regulation.
An implementation timeline that continues to evolve
The application timeline for high-risk requirements changed in 2026. European Commission pages should remain the reference source for applicable dates and guidance still being finalised.
What PRISM can contribute
PRISM can help structure technical evidence on data, performance, robustness, safety and methodology. It does not replace legal classification, regulatory strategy or conformity assessment.
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