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Life sciences update: medical devices equity review, EU Health Data Space, AI in medicines, EMA supply chain actions, ASA rulings and DHSC health claims, Grindr HIV claim, EWHC patent judgment

Published on: 25 April 2024

Published by a Law360 reporter
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  • Data protection and life sciences
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Medical devices

Government reaction to Whitehead Review on systemic bias in UK medical devices

Harriet Hanks, counsel, Sanjana Canumalla, associate, and Matt Allison, trainee, at Freshfields Bruckhaus Deringer, examine and reflect on the findings of the Whitehead Review into equity in medical devices, published on 11 March 2024. See News Analysis: UK government responds to Whitehead Review’s findings of systemic bias in UK medical devices.

Guidance on content of Investigator’s Brochure for clinical investigations of medical devices issued

The Medical Device Coordination Group (MDCG) has published guidance on the Investigator’s Brochure (IB) for clinical investigations of medical devices (MDCG 2024-5). The document, grounded in Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), is intended to aid sponsors in preparing their IB by setting out the information expected within each section, helping anticipate queries from the competent authorities during assessment of the clinical investigation application. See: LNB News 18/04/2024 72...

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