Understanding the regulatory
interplay systematically.
AI software in the medical context operates simultaneously in the intersection of MDR, IVDR and the AI Act. This whitepaper structures the key questions and translates regulatory complexity 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 are automatically classified as high-risk — and why MDR/IVDR classification is the decisive trigger.
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 through end of 2026 and medium-term steps through 2028: portfolio analysis, QMS extension and early involvement of Notified Bodies.
Current deadline extensions in the AI Act
The stretched timeline to 2027/2028 does not create a classic buffer — but a phase in which key regulatory frameworks are not yet fully defined.
MDR Simplification Proposal & Digital Omnibus
How ongoing legislative initiatives continue to reshape the regulatory landscape and why continuous monitoring is essential.