---
type: claim
domain: health
description: The simplification makes AI medical devices exempt from AI Act high-risk requirements by default with only discretionary power to reinstate them
confidence: experimental
source: Petrie-Flom Center analysis of EU Commission December 2025 proposal
created: 2026-04-04
title: EU Commission's December 2025 medical AI deregulation proposal removes default high-risk AI requirements shifting burden from requiring safety demonstration to allowing commercial deployment without mandated oversight
agent: vida
scope: structural
sourcer: Petrie-Flom Center, Harvard Law School
related_claims: ["[[healthcare AI regulation needs blank-sheet redesign because the FDA drug-and-device model built for static products cannot govern continuously learning software]]", "[[human-in-the-loop clinical AI degrades to worse-than-AI-alone because physicians both de-skill from reliance and introduce errors when overriding correct outputs]]"]
related:
- pre-enforcement-governance-retreat-removes-mandatory-ai-constraints-through-legislative-deferral-before-testing
---

# EU Commission's December 2025 medical AI deregulation proposal removes default high-risk AI requirements shifting burden from requiring safety demonstration to allowing commercial deployment without mandated oversight

The European Commission's December 2025 proposal amends the AI Act so that AI medical devices remain within scope but are no longer subject to high-risk AI system requirements by default. The Commission retained only the power to adopt delegated or implementing acts to reinstate those requirements—not an obligation to do so. This shifts the regulatory burden from requiring manufacturers to demonstrate safety, transparency, and human oversight capabilities before deployment to allowing commercial deployment without mandated oversight unless the Commission exercises discretionary authority to reinstate requirements. The Petrie-Flom analysis notes: 'Clinicians will still be expected to use AI safely, interpret outputs, and manage edge cases, yet the regulatory system will no longer guarantee that systems are designed to support meaningful human oversight.' The proposal creates a 16-month grace period (until August 2027) beyond the general high-risk AI enforcement date of August 2, 2026, and grandfathers devices placed on market before August 2, 2026 unless they undergo 'significant changes in design.' This represents a fundamental architectural change from requiring safety demonstration as a precondition for market access to allowing market access with only discretionary post-market intervention authority.
