Whitepaper · Regulatory
AI in MedTech: AI Act, MDR & IVDR in interplay
A structured guide for manufacturers of AI medical devices: classification, high-risk designation, requirements and concrete action steps, instead of regulatory complexity.
- 3
- frameworks in interplay (MDR · IVDR · AI Act)
- Art. 8-15
- AI Act obligations for high-risk AI
- 6
- steps in the manufacturer roadmap
- Reply usually within one working day
- 100% life sciences
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Inside the whitepaper
AI software in the medical context operates simultaneously at the intersection of MDR, IVDR and the AI Act. The whitepaper structures the key questions and translates them into concrete action perspectives.
When is AI software a medical device?
Regulatory classification under MDR and IVDR: intended purpose as the decisive criterion and typical grey areas in practice.
High-risk classification under the AI Act
Which AI systems count as high-risk and why MDR/IVDR classification is the decisive trigger (Art. 6(1) AI Act).
Requirements for high-risk AI (Art. 8-15)
From risk management and data governance to transparency, human oversight and cybersecurity, what the AI Act concretely demands.
Roadmap for manufacturers
Short-term measures and medium-term steps: portfolio analysis, QMS extension and early involvement of notified bodies.
Current deadlines and shifts
The stretched timeline creates no classic buffer but a phase of parallel conformity, including the movements around the Digital Omnibus package.
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