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United Kingdom

Life sciences: UK and EU regulatory, data and IP developments—MHRA devices roadmap, medicines assessment changes, EHDS concerns, ABPI patient access, and unitary SPCs (29 February 2024)

Published on: 29 February 2024

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

  • Medical devices
  • Regulatory framework for medicinal products
  • Data protection and life sciences
  • Research and development
  • Intellectual property
  • Daily and weekly news alerts
  • New and updated content
  • Dates for your diary
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Medical devices

MHRA sets out its Roadmap towards updated medical device rules. Harriet Hanks, counsel, Andrew Austin, partner, Sofia Schaffgotsch, associate, and Honor May, trainee, at Freshfields Bruckhaus Deringer, examine the MHRA’s plans for the future regulatory framework for medical devices, released on 9 January 2024. See News Analysis: MHRA issues Roadmap towards new medical devices rules.

Medical Devices (In Vitro Diagnostic Devices etc) (Amendment) Regulations 2024 SI 2024/221: made under legislative powers in the European Union (Withdrawal) Act 2018 relating to assimilated law. The Regulations amend three pieces of primary legislation, nine pieces of secondary legislation, and one piece of retained direct EU legislation concerning medical devices. They take effect from 21 March 2024. See: LNB News 28/02/2024 9...

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