This is the new MLex platform. Existing customers should continue to use the existing MLex platform until migrated.
For any queries, please contact Customer Services or your Account Manager. Dismiss

EU AI Act, medical devices rules tensions emerge with guidance document

By Luca Bertuzzi ( May 26, 2025, 11:52 GMT | Insight) -- Tensions are emerging between the EU AI Act and existing medical device regulations as efforts to finalize a guidance document stall. A draft Q&A text intended to clarify how the AI Act aligns with the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation has prompted pushback from Germany, France, industry groups, and third-party verifiers known as notified bodies for not sufficiently providing legal clarity. Key concerns include the unresolved legal conflict over real-world clinical testing for AI-powered medical devices. Without a clear resolution, medical devices companies may face regulatory deadlocks that prevent clinical trials and market entry. Despite the European Commission’s plan to publish the Q&A document by fall, it remains uncertain how much input stakeholders will have in shaping the final document.Health technology organizations are seeing significant tensions between the EU AI Act and the regulations for medical devices come to the surface, as discussions over a questions and answers document have reached an impasse....

Prepare for tomorrow’s regulatory change, today

MLex identifies risk to business wherever it emerges, with specialist reporters across the globe providing exclusive news and deep-dive analysis on the proposals, probes, enforcement actions and rulings that matter to your organization and clients, now and in the longer term.


Know what others in the room don’t, with features including:

  • Daily newsletters for Antitrust, M&A, Trade, Data Privacy & Security, Technology, AI and more
  • Custom alerts on specific filters including geographies, industries, topics and companies to suit your practice needs
  • Predictive analysis from expert journalists across North America, the UK and Europe, Latin America and Asia-Pacific
  • Curated case files bringing together news, analysis and source documents in a single timeline

Experience MLex today with a 14-day free trial.

Start Free Trial

Already a subscriber? Click here to login

Related Sections