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Life sciences regulatory round-up, 3 July 2025: AI medical devices, EU AI Act/MDR–IVDR guidance, NHS tech adoption, clinical trials reforms and hub-and-spoke dispensing

Published on: 03 July 2025

Published by a LexisNexis Life Sciences expert
Legal News
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In this issue:

  • Medical devices
  • Research and development
  • Pharmaceuticals—regulatory framework
  • LexTalk®Life Sciences: a Lexis®Nexis community
  • Daily and weekly news alerts
  • New and updated content
  • Trackers
  • Latest Q&A
  • Useful information

Medical devices

New MDCG guidance on the interplay between the MDR/IVDR and the EU AI Act

Hélène Boland, senior associate, and Fabien Roy, partner at Hogan Lovells, outline the principal insights from MDCG 2025-6 on how the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) intersect with the EU AI Act. See News Analysis: New MDCG guidance on the interplay between the MDR/IVDR and the EU AI Act.

MHRA announces AI Airlock expansion and joins global health AI regulatory network

The Medicines and Healthcare products Regulatory Agency (MHRA) has invited applications to an enlarged AI Airlock programme after last year’s pilot. The agency has also become the first founding member of Health AI’s new international network of health regulators, focused on exchanging early safety signals and shaping worldwide standards. In addition, MHRA’s Centre of Excellence for Regulatory Science and Innovation (CERSI) partner, RADIANT, has unveiled an Innovator Support Programme, while the agency readies Good Machine Learning Practice guidance to align with global principles. Supporting broader adoption. These...

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