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United Kingdom

EU and UK life sciences regulatory briefing: MDR/IVDR implementation and MIR update, AI Code of Practice delay, EMA competing interests and EudraVigilance updates, and UK Clinical Trials reforms

Published on: 08 May 2025

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

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

Medical devices

AI model providers get confirmation of delays to EU Code of Practice

MLex reports that developers of general-purpose artificial intelligence (GPAI) systems — including OpenAI, Google and Microsoft — have been informed that the statutory deadline for a definitive Code of Practice to support compliance with the EU AI Act will be missed, and publication may not arrive for a few more months. The postponement reflects work to align the Code with guidance on GPAI obligations, and efforts to secure buy-in from major AI firms while under pressure from the US government. See: AI model providers get confirmation of delays to EU Code of Practice.

MedTech’s paper to support effective implementation of the MDR/IVDR ahead of the reform expected in 2026

MedTech Europe has produced a set of succinct one-pagers intended to facilitate effective implementation of the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), in advance of a wider legal overhaul anticipated in 2026...

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