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Life sciences regulatory highlights: AI medical devices and EU AI Act procurement, EU Critical Medicines Act, MHRA fee rises, EMA shortages platform, EFPIA UWWTD challenge, VPAG payments – 13 March 2025

Published on: 13 March 2025

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

  • Medical devices
  • Post-market
  • Pharmaceuticals—regulatory framework
  • Commercialisation
  • Daily and weekly news alerts
  • New and updated content
  • Trackers
  • Useful information

Medical devices

AI model providers see European Commission finalise panel of scientific experts

MLex: The European Commission has adopted an Implementing Act establishing and governing a scientific panel of independent experts to advise and assist EU and national authorities in enforcing the EU AI Act’s provisions for general-purpose artificial intelligence models. The definitive Act departs materially from an earlier draft on sensitive points, including conflicts of interest, internal procedures and transparency.

Commission updates AI procurement model clauses following EU AI Act adoption

On 5 March 2025, the European Commission issued updated model contractual clauses for AI procurement, revising the September 2023 version to align with the EU AI Act adopted in June 2024. The update delivers a comprehensive set for high-risk AI systems, a lighter template for non-high-risk AI, and practical guidance. The clauses are designed to support public buyers in implementing AI procurement practices that meet the new regulatory framework...

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