AI in Medical Technology: The Interplay of AI Act, MDR and IVDR

Two possible product regimes plus an additional AI legal framework: depending on its intended purpose, AI software in medical technology falls under either the MDR or the IVDR. Where it also qualifies as an AI system within the meaning of the AI Act, the relevant AI Act requirements have to be taken into account as well. Manufacturers have to interlock these regulatory layers consistently, from classification through post-market surveillance.

The full whitepaper with manufacturer roadmap structures the key questions and translates regulatory complexity into concrete courses of action. The sections below give an overview of the core topics.

When is AI software a medical device?

Regulatory classification under the MDR and IVDR: the intended purpose as the decisive criterion and typical gray 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

Regulation (EU) 2026/1744 (the digital omnibus on AI, published in the Official Journal on 24 July 2026 and in force since 27 July 2026) extended the application deadlines for high-risk AI systems. Under Art. 6(2) in conjunction with Annex III, the high-risk obligations apply to the use cases listed there from 2 December 2027; under Art. 6(1) in conjunction with Annex I, for AI embedded in products, from 2 August 2028. For medical technology, however, the later date does not apply across the board: it only covers AI systems that are themselves a medical device or in vitro diagnostic (or a safety component of one) and whose conformity assessment under the MDR or IVDR requires a notified body. Obligations already in force remain unaffected by the postponement: the AI literacy requirements under Art. 4 have applied since 2 February 2025, and the transparency obligations under Art. 50 have generally applied since 2 August 2026.

MDR Simplification Proposal and Digital Omnibus

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