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MHRA guidance released: Clinical trials that include an in vitro diagnostic device

The MHRA has published guidance on clinical trials which include an in vitro diagnostic device. The guidance is split into three parts: definitions, using IVDs in a clinical trial, and applying for approval of a clinical trial that includes an IVD device. You can read the guidance here.
Ben Kemp
October 7, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK-China Intellectual Property Newsletter

UK-China Intellectual Property Newsletter September 2025 Our China IP Newsletter is published in English and is intended to inform UK stakeholders of recent developments in the Chinese IP environment. The most recent edition covers news from September 2025 Read the newsletter here
Ben Kemp
October 2, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

One IPO update – what’s changing when applying for patents

One IPO update - what's changing when applying for patents Without doubt, the part of our new One IPO service we've received most interest in is applying for patents. It's the most crucial part of the process and getting it right is the difference between having meaningful legal protection or none at all. There are big changes coming to the…
Ben Kemp
October 2, 2025
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October is Cybersecurity Awareness Month, is your team AI-ready? 

BIVDA member Qserve is running EU AI act literacy training that may be of use to members. The EU AI Act requires AI literacy training for staff developing and deploying as well as those using AI. AI Literacy - Questions & Answers | Shaping Europe’s digital future
Ben Kemp
October 2, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

ESG California List of companies – expected to report

Includes a number of the larger Diagnostic companies in the list. Although not applicable to the SMEs or even some of the larger businesses, again these businesses will find that if they’re suppliers to the bigger companies then they’ll still be asked for their emissions etc. so the bigger businesses can do their own reporting. California Releases List of More…
Ben Kemp
October 2, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Commission publishes report on action to enhance access to healthcare

Commission publishes report on action to enhance access to healthcare The Commission has published a report showcasing EU4Health funded action to enhance access to healthcare across the EU. The report finds that healthcare coverage has a poverty-reducing impact, comparable to that of cash transfers such as unemployment benefits. Since 2019, however, there has been a rise in the share of…
Ben Kemp
October 2, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Working and engaging with China including Hong Kong and Macao

Working and engaging with China including Hong Kong and Macao Page summary: Guidance for UK nationals and organisations considering professional engagement with Chinese individuals and organisations. Change made: First published. Time updated: 1:17pm, 24 September 2025
Ben Kemp
October 2, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates – WC 30 Sept

The UK’s trade agreements Page summary: Find out which trade agreements the UK has signed and which the UK is negotiating. Change made: ‘UK-India Trade Deal’ Collection page added under ‘Trade agreements signed but not enforced.’ Time updated: 9:37am, 22 September 2025 Community Investment Tax Relief: accreditation of community development finance institutions Page summary: Guidance for bodies seeking accreditation under…
Ben Kemp
October 2, 2025
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