ARTICLE SUMMARY:
The European Union’s AI Act retains device mandates. Excerpted from Pathways’ Picks May 13: Makary Exits FDA, EU AI Act Reforms Disappoint, UK Seeks Input, and More.
Last week, EU lawmakers reached agreement on reforms to the AI Act, but left out industry-supported proposals that would have removed distinct conformity assessment requirements for AI-enabled medical devices alongside Medical Device and IVD Regulation mandates. “We had advocated clearly and consistently for a single, sector-specific compliance pathway, whereby high-risk AI requirements for medical technologies are implemented through the existing [MDR and IVDR],” MedTech Europe lamented in a May 7 statement. “Layering AI Act obligations on top does not raise the bar; it adds complexity, increases administrative burden, and risks slowing patient access to innovative technologies.”
The technical elements of a conformity assessment for an AI device will be the same whether it is performed under the authority of the AI Act or not, EU notified body group TEAM-NB confirmed in a statement. But last week’s agreement appears to maintain the requirement for notified bodies to gain a distinct AI Act designation to perform such assessments, a bureaucratic step that could lead to challenges in meeting the August 2028 deadline for AI devices to be assessed under the new law, TEAM-NB suggests. “If current policies are further pursued, we must expect readiness issues across stakeholders, heterogenic national implementations, bottlenecks, and capacity issues towards the end of the deadline, resulting in a failed implementation of the AI Act for medical devices and IVDs,” the group writes.
The fight for streamlining EU AI medtech oversight isn’t over, however. A similar provision to what industry supported in the AI Act reform, removing parallel conformity assessment obligations, was included by the European Commission in its recent plan to revamp the MDR and IVDR. “We call on EU legislators and the European Commission to use the MDR/IVDR revision to address the regulatory coherence gap left by today’s deal,” MedTech Europe said.