AI in Medical Technology: AI Act, MDR and IVDR in Combination

Three regulatory frameworks, one product: AI software in medical technology falls simultaneously within the scope of the MDR, the IVDR and the AI Act. Anyone developing or already marketing an AI-supported medical device today must keep all three frameworks in view at the same time.

This whitepaper structures the key questions and translates regulatory complexity into concrete perspectives for action.

When is AI software a medical device?

Regulatory classification under the MDR and IVDR: the intended purpose as the decisive criterion and typical grey areas in practice.

High-risk categorization under the AI Act

Which AI systems are automatically classified as high-risk and why the MDR/IVDR classification is the decisive trigger.

Requirements for high-risk AI (Art. 8-15)

From risk management and data governance through transparency and human oversight to cybersecurity - what the AI Act concretely requires of manufacturers.

Manufacturer roadmap through 2028

Short-term measures by the end of 2026 and medium-term steps through 2028: portfolio analysis, QMS expansion and early involvement of notified bodies.

Recent deadline extensions in the AI Act

The extended timeline through 2027/2028 does not create a classic buffer - but rather a phase in which key regulatory conditions have not yet been conclusively defined.

MDR Simplification Proposal and Digital Omnibus

How ongoing legislative initiatives continue to shape the regulatory landscape and why continuous monitoring remains indispensable.