Regulatory Landscape for Medical AI: FDA, CE Marking, and Ukrainian MHSU

February 24, 2026Open Access

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Key Points

The study aims to analyze the regulatory environment for medical AI technologies, focusing on the roles of the FDA, CE marking, and Ukrainian MHSU.
Conducted a comprehensive review of regulatory documents
Analyzed compliance requirements of FDA and CE marking
Examined Ukrainian MHSU regulations related to medical AI
Identified key similarities and differences in regulatory approaches across regions
Revealed challenges faced by companies in navigating these regulations
Suggested potential pathways for harmonizing standards internationally

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This research article explores the regulatory frameworks for medical AI in Ukraine, FDA, and CE marking, highlighting implications for compliance.

Research article from Stabilarity Research Hub: Regulatory Landscape for Medical AI: FDA, CE Marking, and Ukrainian MHSU

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Ivchenko et al. (2026) studied this question.

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