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Ben Kemp

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 27 October)

Medical devices given exceptional use authorisations Page summary: List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled. Change made: Updated – ‘List of medical devices given exceptional use authorisations’: (DEU/008/2022/015) 10 April 2026 – Extension issued Time updated: 10:49am, 21 October 2025 Government cuts red tape…
Ben Kemp
October 31, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
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