Summary
AI Regulation for AI-enabled medical devices is entering a period of significant change. While the European Commission has proposed measures to simplify the regulatory landscape, manufacturers and healthcare organisations are still faced with considerable uncertainty regarding timelines, harmonised standards, and future compliance obligations. In this article, Leon Doorn explores how the proposed Digital Omnibus and the MDR/IVDR simplification proposal could reshape the implementation of the EU AI Act and what these developments mean for organisations preparing for AI Compliance.
The proposed transition of MDR- and IVDR-regulated medical devices from Section A to Section B of Annex I aims to reduce duplicated regulatory requirements and simplify the interaction between the Medical Device Regulations and the AI Act. At the same time, the proposed extension of AI Act implementation timelines acknowledges practical challenges, including the delayed availability of harmonised standards, ongoing work within CEN/CENELEC, and the complexity of conformity assessments for high-risk AI systems.
Despite these proposals, the legislative picture remains uncertain. Both initiatives are still progressing through the European legislative process, making it difficult for organisations to predict exactly when new requirements will apply or which standards will ultimately become harmonised. This uncertainty creates difficult strategic decisions for manufacturers investing in product development, quality management systems, and regulatory programmes.
The article also addresses several practical questions organisations are currently asking. Should manufacturers continue implementing AI Act requirements while proposals are still under discussion? Should they continue monitoring and adopting emerging standards? And how should healthcare providers prepare when future obligations remain unclear? Leon explains why delaying preparations may introduce greater risk than continuing to build robust compliance capabilities.
From an AI Compliance perspective, the core expectations remain largely unchanged. Organisations should continue strengthening quality management systems, data governance, human oversight, logging, risk management, and technical documentation. Whether these requirements are ultimately enforced directly through the AI Act or incorporated into MDR and IVDR implementation, these capabilities will remain fundamental to demonstrating compliance and supporting safe, effective AI-enabled medical devices.
The article also highlights the broader implications of the evolving Artificial Intelligence Law framework in Europe. While regulatory simplification is expected to reduce unnecessary duplication over the long term, the transition period will require organisations to remain flexible and prepared for multiple legislative outcomes.
Ultimately, regulatory certainty has yet to catch up with regulatory ambition. Until the legislative framework is finalised, manufacturers and healthcare providers should continue investing in sound governance, established quality systems, and practical AI Compliance measures. A proactive, risk-based approach to AI Regulation remains the most reliable strategy for navigating an increasingly complex regulatory environment while remaining prepared for future developments.
Explore the full article for a detailed analysis here: 2026 starts with a high-level of legal uncertainty for AI/Ml-enabled medical devices
