Aligning the AI Act and the MDR/IVDR: What the AI Act simplification proposal means for AI-enabled medical devices

St John Lynch, Niamh and Loughran, Roisin and Mc Hugh, Martin and McCaffery, Fergal (2026) Aligning the AI Act and the MDR/IVDR: What the AI Act simplification proposal means for AI-enabled medical devices. Journal of Medical Device Regulations, 23 (2). pp. 57-64.

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Abstract

This article examines the European Commission’s December 2025 ‘Simplification Package’ and its implications for the regulation of artificial intelligence (AI)-enabled medical devices under the AI Act and the Medical Devices Regulations (MDR/IVDR). Her article explains how the proposed relocation of the MDR/IVDR within the AI Act is intended to reduce regulatory duplication, clarify obligations, and create a more predictable pathway for innovation while maintaining high standards of patient safety. By analysing the proposed legislative changes, relevant guidance, and industry perspectives, this article highlights how compliance for AI-enabled medical devices is expected to focus primarily on the obligations contained in Articles 8–15 of the AI Act and how these can be integrated into existing MDR/IVDR conformity assessment processes through a unified technical documentation approach. The article provides practical insight for manufacturers, Notified Bodies, and policymakers navigating the evolving European regulatory landscape as the AI Act approaches full application in August 2026, offering guidance on how to implement trustworthy, compliant AI within medical devices while supporting continued innovation in digital health.

Item Type:	Article
Uncontrolled Keywords:	AI, Artificial Intelligence, Medical Device, Regulation, MDR/IVDR
Subjects:	Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	Niamh StJohnLynch
Date Deposited:	13 May 2026 09:28
Last Modified:	13 May 2026 09:28
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/1051

Available Versions of this Item

• © Journal of Medical Device Regulation – May 2026 1 A Single Regulatory Framework for AI‑Enabled Medical Devices: Implications of the EU Simplification Digital Package and Omnibus Proposal. (deposited 10 Mar 2026 16:08)
  • A Single Regulatory Framework for AI‑Enabled Medical Devices: Implications of the EU Simplification Digital Package and Omnibus Proposal. (deposited 25 Mar 2026 12:12)
    • Aligning the AI Act and the MDR/IVDR: What the AI Act simplification proposal means for AI-enabled medical devices. (deposited 13 May 2026 09:28) [Currently Displayed]

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