AI Airlock, CERSIs and a new global AI network for health regulators Page summary: Med Tech Regs blog, June 2025: A focus on Software and AI. Change made: First published. Time updated: 9:32am, 27 June 2025
Ben KempJuly 4, 2025
Not clear exactly how this impacts, as it references updated lists not in the notice, so difficult to see exactly which tariff codes etc. have been amended, but could impact import charges for raw materials. This is part of the regular updates of customs charges. The Customs (Tariff and Miscellaneous Amendments) (No. 2) Regulations 2025 These Regulations are made under…
Ben KempJuly 4, 2025
Please not the changes being made to UK customs regulations, include postal packet and universal package services, including for items declared as temporarily being in the UK. The Customs (Miscellaneous Amendments) Regulations 2025 This instrument contains various amendments to Customs secondary legislation made under the Taxation (Cross-border Trade) Act 2018 (c. 22) (“TCTA”), and amendments to the Postal Packets (Revenue…
Ben KempJuly 4, 2025
Apply for active substance renewal by the deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming up for the following active substance/product type combinations under GB BPR: 27 December…
Ben KempJuly 4, 2025
UK Health Research Authority are requesting feedback by 10th September on guidance to the new Clinical Trials Regulation. Note that the new regulation applies to medicinal products, however clinical trials involving combination products, or using IVDs are in scope, although you have to hunt through the Guidance and find the reference to: Combined trials of an investigational medicinal product and…
Ben KempJuly 4, 2025
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Business Plan for 2025/26, reaffirming its commitment to keeping patients safe and enabling access to high quality and effective medical products through innovation across the UK. The plan appears forward-looking, acknowledging their purpose as an engine of economic growth and the need to be bold and ambitious in the…
Ben KempJuly 1, 2025
UK MHRA leads safe use of AI in healthcare as first country in new global network Page summary: The MHRA will help shape international rules for AI in healthcare – speeding up access to safe, effective technologies into the NHS and worldwide. Change made: First published. Time updated: 2:20pm, 24 June 2025
Ben KempJune 26, 2025
UKHSA Presents Page summary: UKHSA Presents is a new webinar series profiling the science behind how we prevent, prepare for and respond to infectious diseases and environmental hazards to keep all our communities safe. Change made: Updated next event details and added sign-up link. Time updated: 9:30am, 24 June 2025
Ben KempJune 26, 2025