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UK and EU life sciences legal and regulatory update: device regulatory relief, MHRA AI framework, NICE HealthTech expansion, clinical trials reform, CMA TTBER replacement, pharmaceutical advertising enforcement, IP costs ruling

Published on: 02 October 2025

Published by a LexisNexis Life Sciences expert
Legal News
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  • Medical device
  • Research and development
  • Post-market
  • Competition in life sciences
  • Intellectual property
  • Pharmaceuticals—regulatory framework
  • Advertising of medicines
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Medical device

MedTech Europe leads industry call for EU to provide medical device regulatory relief by early 2026

MedTech Europe, alongside 35 national associations, has pressed the European Commission to act quickly on regulatory hurdles impacting the medical device and diagnostic sectors. Although EU officials are gathering evidence to underpin future reforms of the medical device and in vitro diagnostic regulations—aimed at simplification and greater efficiency—the signatories to the open letter contend that prompt relief is also crucial. They urge a blend of short-term actions with longer-term legislative change. In particular, the letter requests an implementing act to standardise Notified Bodies’ practices, pilot pathways for orphan, paediatric and breakthrough devices, and a targeted extension to re-certification obligations for selected products. MedTech Europe says aligning requirements for Notified Bodies would cut duplication, accelerate assessments, and lessen the overall regulatory load...

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