A Single Regulatory Framework for AI‑Enabled Medical Devices: Implications of the EU Simplification Digital Package and Omnibus Proposal

Abstract

The European Commission’s Simplification Proposal of 16 December 2025 aims to simplify, reduce burden and increase predictability, while maintaining high levels of public health protection. It introduces significant reforms to many aspects of medical device regulation including the regulatory landscape for Artificial Intelligence–enabled Medical Devices (AIeMD). Central to these reforms is the proposed relocation of the MDR/IVDR from Annex I Section A to Section B of Regulation (EU) 2024/1689 (the AI Act)1. This structural change addresses industry concerns related to regulatory burden, innovation barriers, and uncertainty regarding the interaction between the MDR/IVDR and the AI Act. The proposal clarifies that while AI‑enabled medical devices remain high‑risk, the AI Act obligations that apply are limited to the horizontal requirements referenced under Article 2(2), triggering compliance with Articles 8–15. This paper analyses the regulatory changes and technical implications of these amendments, evaluates the supporting guidance in MDCG‑2025‑6, and synthesizes the key issues presented at the Irish MedTech event on 5 March 2026. The findings indicate that the proposal recalibrates regulatory expectations by allowing better integration of AI Act high‑risk obligations within MDR/IVDR conformity assessment pathways, thereby reducing duplication and improving predictability. However, widespread confusion persists among manufacturers, with some reporting abandonment of AI Act implementation altogether. The paper concludes with recommendations for manufacturers, notified bodies (NB), and policymakers as Europe prepares for the AI Act’s entry into force on 2 August 2026.

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