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 KempOctober 31, 2025
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 KempOctober 29, 2025
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 KempOctober 28, 2025
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 KempOctober 28, 2025
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 KempOctober 28, 2025
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 KempOctober 28, 2025
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 KempOctober 28, 2025