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Ben Kemp

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Updated information for BSI clients on Periodic Safety Update Reports (PSURs)

Following legislation amendments (EU)2023/607, (EU)2024/1860 and new PMS regulations applicable in Great Britain, BSI is providing updated information on PSUR. Topics covered in this communication: BSI PSUR evaluation process and PSUR submission timelines Combined reviews of PSUR under EU regulations and UK MDR PMS requirements for Great Britain PSURs for legacy devices placed on the market under the Directives PSUR…
Ben Kemp
October 31, 2025
HighlightsHighlights Archive

Media Monitoring: 23rd – 29th October

Could expanding BRCA gene testing save lives in breast and ovarian cancer? Although cancer is not usually inherited, certain types, including breast and ovarian, can be triggered by inherited gene faults, meaning they can run in families. Now that we can test for these mutations, could – and should – we be testing as many people as possible to identify…
Ben Kemp
October 29, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Nexperia Semiconductor Supply Exposure — feedback for DHSC

DHSC have highlighted an emerging risk to the UK medical technology supply chain following recent developments involving Nexperia, a major global supplier of legacy semiconductors. The Dutch government’s recent intervention and the subsequent Chinese export ban on Nexperia products have disrupted a significant portion of the company’s supply chain, with potential implications for the availability of critical chips used in…
Ben Kemp
October 28, 2025
Membership NewsMembership News Archive

NICE recruiting HealthTech professional committee members

NICE have a number of roles available across their three HealthTech Committees: Diagnostics advisory committee Medical technologies advisory committee Interventional procedures advisory committee Applicants may be appointed to any of the three committees, unless otherwise indicated during the interview process. They are particularly interested in candidates with experience in the following areas: NHS manager/NHS finance manager (multiple roles) Nurse or…
Ben Kemp
October 28, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

AI Growth Lab: Call for Evidence

The MHRA are seeking evidence on a pioneering cross-economy sandbox, that would oversee the deployment of AI-enabled products and services that current regulation hinders. The Lab would deliver more dynamic UK regulation. Regulatory decisions on novel technologies can often take years, but we know that regulatory sandboxes can accelerate time to market by 40%. The AI Growth Lab would support…
Ben Kemp
October 28, 2025
Infectious Diseases Working PartyInfectious Diseases Working Party ArchiveMembership NewsMembership News ArchiveNear Patient Testing Working PartyNear Patient Testing Working Party Archive

Infectious Diseases and Near Patient Working Party Agendas – 6th November

The Infectious Diseases and Near Patient Working Parties are taking place back-to-back on Thursday 6th November. The Infectious Diseases Working Party agenda can be found here. Highlights include presentations on: Advancing the 100 Days Mission for Diagnostics: 2025 Global Gap Assessment Tuberculosis at home and away: diagnostic progress, pitfalls and prospects Update from the Fleming Initiative Register here. The Near…
Ben Kemp
October 28, 2025
Membership NewsMembership News Archive

First meeting of National Commission into the Regulation of AI in Healthcare

Last week, the MHRA convened the National Commission into the Regulation of AI in Healthcare for the first time. The Commission brings together global AI leaders, clinicians, regulators, and patient advocates to advise on future-ready frameworks for regulation of AI in health. BIVDA is a member of the Technology Working Group as part of the commission, represented by our Head…
Ben Kemp
October 28, 2025
HighlightsHighlights Archive

Generation Study providing lifechanging early diagnoses for babies across UK

A baby born with a rare eye cancer — typically diagnosed only after symptoms develop in early childhood — is among the growing number of newborns receiving earlier diagnoses and life-changing treatment through the Generation Study. This world-leading research programme, led by Genomics England in partnership with NHS England, uses whole-genome sequencing (WGS) to screen 100,000 newborns for over 200…
Ben Kemp
October 28, 2025
Membership NewsMembership News Archive

NHSE Detailed Market Sounding – April 2027 Scope 3 Reporting and Target Setting: Feedback Session

NHS England’s Net Zero and Sustainable Procurement Team will share a summary of the feedback received in the Detailed Market Sounding - Scope 3 target setting and reporting and outline the next steps. The event will take place on 17 November 2025 at 3:00pm – 3:45pm. You can register here. Please note the joining link will be shared the morning…
Ben Kemp
October 28, 2025
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