EU Experience: CE-Marked Diagnostic AI
Article #8 in Medical ML for Ukrainian Doctors Series
By Oleh Ivchenko | Researcher, ONPU | Stabilarity Hub | February 8, 2026
📋 Key Questions Addressed
- How does the European regulatory framework for medical AI differ from the US FDA approach?
- What is the impact of the EU AI Act on medical device software, and how does dual regulation work?
- What lessons can Ukrainian healthcare draw from the EU’s evidence-focused approach?
Context: Why This Matters for Ukrainian Healthcare
Ukraine’s regulatory trajectory aligns with the EU Medical Device Regulation (MDR) through ongoing European integration reforms. Understanding the European CE marking process—with its emphasis on clinical evidence and post-market surveillance—directly informs how Ukrainian hospitals should evaluate AI diagnostic tools.
A Different Regulatory Philosophy: EU vs US
CE-Marked AI Devices: The Numbers
~500-700
Total CE-marked AI devices
~53%
Radiology focus
~60%
Class IIa devices
~35%
Class IIb/III (high-risk)
The EU AI Act: A New Layer of Regulation
The World’s First Comprehensive AI Law
The EU AI Act (Regulation EU 2024/1689), adopted March 2024, represents the world’s first comprehensive legal framework for artificial intelligence. For medical devices, this creates a dual regulatory burden.
“`mermaid
graph TD
A[Medical AI Device] –> B{MDR Classification?}
B –>|Class I| C[Not High-Risk AI]
B –>|Class IIa+| D[High-Risk AI]
D –> E[MDR Compliance
+ AI Act Compliance]
E –> F[Risk Management
Art. 9]
E –> G[Data Governance
Art. 10]
E –> H[Technical Documentation
Art. 11]
E –> I[Transparency
Art. 13]
E –> J[Human Oversight
Art. 14]
style D fill:#dc3545,color:#fff
style E fill:#ffc107,color:#000
“`
AI Act Risk Classification
Timeline for AI Act Compliance
“`mermaid
timeline
title EU AI Act Compliance Milestones
August 2024 : AI Act enters into force
May 2025 : General-purpose AI obligations
August 2026 : Most high-risk AI obligations
August 2027 : Medical device AI obligations (36-month transition)
“`
The Dual Regulatory Framework: MDR + AI Act
Integration, Not Duplication
Article 11(2) of the AI Act allows manufacturers to maintain a single technical documentation file that combines MDR and AI Act requirements.
Requirements for High-Risk Medical AI
European Market Leaders and Notable Devices
Top Companies in European Medical AI
Notable CE-Marked AI Applications
🎀 Breast Cancer
Transpara (ScreenPoint)
Mammography triage, Class IIb
🫁 Chest X-ray
qXR (Qure.ai)
TB/pneumonia detection, Class IIa
🧠 Stroke Detection
Viz LVO (Viz.ai)
Large vessel occlusion alert
Clinical Evidence: The European Approach
MDR’s Clinical Evidence Requirements
Post-Market Clinical Follow-up (PMCF)
A distinctive EU requirement is ongoing PMCF studies after market entry:
- PMCF Plan: Proactive collection of clinical data post-CE mark
- PMCF Studies: Prospective/retrospective studies in real-world use
- PMCF Report: Regular updates, part of technical documentation
- Periodic Safety Update Report: Mandatory for higher-risk devices
European AI in Action: Case Studies
Case Study 1: AI in European Breast Cancer Screening
Case Study 2: The Colonoscopy Deskilling Warning
⚠️ Critical Finding
A pivotal 2025 Lancet study on AI-assisted colonoscopy revealed:
- Initial AI assistance: Improved adenoma detection
- After 6 months: Physician detection rates FELL when AI was withdrawn
- Implication: Over-reliance creates skill degradation
“Researchers found that over six months of using AI, clinicians’ ability to spot concerning features in colonoscopies declined when AI was not used during specific procedures.”
— Time, January 2025
Challenges Facing European Medical AI
“`mermaid
mindmap
root((EU Medical AI
Challenges))
Regulatory Complexity
Dual MDR + AI Act
Two sets of documentation
Definition ambiguity
Notified Body Bottleneck
Only ~40 MDR bodies active
AI Act accreditation emerging
Limited dual-accredited
Market Fragmentation
National reimbursement
Language requirements
HTA variation
SME Impact
High documentation costs
Disproportionate burden
Innovation barrier
“`
Practical Implications for Ukrainian Healthcare
What the EU Experience Teaches
Recommendations for Ukrainian Hospitals
- Prioritize CE-marked devices: EU certification provides stronger clinical evidence than 510(k)-only clearance
- Demand PMCF data: Ask vendors for post-market clinical follow-up results
- Plan for dual compliance: Expect both MDR-style and AI Act-style requirements
- Build monitoring infrastructure: Implement local performance tracking
- Train for collaboration: Prevent deskilling through proper training
Conclusions: Original Insights
🌍 Global Future
The EU’s dual regulatory framework represents the global future—other jurisdictions will likely adopt similar models
✅ Quality Filter
Stricter clinical evidence requirements may result in fewer but better-validated tools
⚠️ Deskilling Risk
European studies show AI assistance can degrade physician skills when over-relied upon
📊 PMCF Advantage
Devices with robust post-market data will increasingly differentiate themselves
Questions Answered
✅ How does the EU regulatory framework differ from the US FDA approach?
The EU requires stronger clinical evidence through MDR conformity assessment, mandatory Notified Body review, and ongoing Post-Market Clinical Follow-up. The AI Act adds a second regulatory layer.
✅ What is the impact of the EU AI Act on medical device software?
Medical AI devices (Class IIa and above) are automatically classified as “high-risk AI,” requiring dual compliance by August 2027.
✅ What lessons can Ukraine draw from the EU approach?
The EU model emphasizes evidence-based approval, ongoing monitoring, and human-AI collaboration—principles Ukraine should adopt as it aligns with EU standards.
Next in Series: Article #9 – UK NHS AI Lab: Lessons Learned
Series: Medical ML for Ukrainian Doctors | Stabilarity Hub Research Initiative
Author: Oleh Ivchenko | ONPU Researcher | Stabilarity Hub