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Regulatory Affairs Newsletter Archive

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The Justification of Practices Involving Ionising Radiation Regulations 2004: guidance on their application and administration

The Justification of Practices Involving Ionising Radiation Regulations 2004: guidance on their application and administration Page summary: Guidance on the application of the regulations and the administrative procedures that will be used by government in reaching justification decisions. Change made: The guidance has been updated to reflect a change in contact details for the Justification Application Centre, legislative and departmental…
Ben Kemp
October 21, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Diagnostic tools selected for phase 2 of the MHRA’s AI Airlock Programme

Seven emerging AI healthcare technologies have been selected to move into the next phase of the MHRA’s AI Airlock programme, with pleasing number of diagnostic tools chosen. The cohort includes tools aimed at dramatically reducing waiting times for tests, such as shrinking a bowel cancer screening process from weeks to minutes, and detecting conditions such as skin cancer, genetic eye…
Ben Kemp
October 21, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA issues updated guidance to reflect the implementation of the revised fee structure

The MHRA have issued the revised DORS Fees Guidance to reflect the implementation of the revised fee structure being implemented from 1st April 2026. We have extracted the key sections from the updated MHRA product registration webpage for members below. Fees from 1 April 2026 A new fee is planned to come into effect on 1 April 2026 and will…
Ben Kemp
October 15, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

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
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