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MHRA Updates (WC 2 June)

AI Airlock: the regulatory sandbox for AIaMD Page summary: A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD). Change made: Published link to webinar for 19 June 2025 Time updated: 10:34am, 30 May 2025 Digital mental health technology Page summary: The Wellcome Trust has…
Ben Kemp
June 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

IP Connect: Exclusive insights from Washington talks and latest policy updates from the UK

London to host world's largest IP event in 2026 The UK's global leadership in IP has been recognised with the announcement that the International Trademark Association (INTA) will hold its 148th Annual Meeting in London from 2-6 May 2026. This prestigious event – the largest gathering of IP professionals and brand owners worldwide – is expected to attract more than…
Ben Kemp
June 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 29-05-25

Getting it right at the border  This newsletter from the Animal and Plant Health Agency (APHA) covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: Some of the messages in this edition were originally sent last week, However, they remain…
Ben Kemp
June 9, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations

Members have just over 2 weeks to ensure compliance with the new UK Post Market Surveillance Regulations. This date sees a significant update to the UK Medical Device Regulation 2002 for IVDs and medical devices. Stuart Angell, Chair of BIVDA's Regulatory Affairs Working Party, provides a rundown of what members need to know: Systematic Data Collection: Manufacturers must establish and…
Ben Kemp
June 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 26 May)

Major investment partnership worth £24 billion to transform key growth sectors and deliver affordable housing across UK Page summary: A major new partnership between the Crown Estate and Lendlease has been agreed which will unlock housing and science innovation hubs across the UK worth £24 billion. Change made: First published. Time updated: 10:43am, 19 May 2025 PM secures new agreement…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 26 May)

Awarding ten-year R&D funding: guidance for departments and ALBs Page summary: What government departments and arms-length bodies (ALBs) need to consider when awarding ten-year, or other long-term research and development (R&D) funding. Change made: First published. Time updated: 12:01am, 19 May 2025 Government to set new ten-year budgets for R&D funding Page summary: New criteria to give certainty to world-class…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 26 May)

Transport goods in Europe in vans or car and trailers Page summary: What transport companies and couriers need to do to use vans and car and trailers over 2.5 tonnes to transport goods in Europe. Change made: Removed content about having a member of staff temporarily recognised as a transport manager because you can no longer apply to do this.…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Updates (WC 26 May)

DHSC counter-fraud policy: summary Page summary: The Department of Health and Social Care’s approach to preventing and detecting fraud, bribery and corruption. Change made: First published. Time updated: 3:13pm, 20 May 2025 UK adopts historic Pandemic Agreement Page summary: Better protections for British public and NHS thanks to deal adopted at the World Health Assembly in Geneva. Change made: First…
Ben Kemp
May 28, 2025