What EU AI Act - High-Risk AI Systems in Medical Devices & Healthcare (2026) requires
Under the EU AI Act, most AI systems used in medical devices, clinical decision support, patient risk assessment, and biometric categorization are classified as high-risk. Providers must comply with strict obligations including risk management, data governance (Article 10), transparency, human oversight, accuracy, robustness, cybersecurity, conformity assessment, CE marking, and post-market monitoring.
Pillar: Medical & Healthcare · Authority: European Commission & Notified Bodies · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/eli/reg/2024/1689/oj
SHA-256 integrity: bbd7599fb137372aed2845b1492324dc6ed3c57c11661a1acc10e134b530935d
Primary Citations — 3 traced to source
- Regulation (EU) 2024/1689 (EU AI Act) - Articles 6, 9, 10, 15, 61 and Annex III
- EU AI Act Medical Device Coordination Group Guidance
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