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Ben Kemp

Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

CTDA (Coronavirus Test Device Approvals) Update

The MHRA recently announced that the current CTDA (Coronavirus Test Device Approvals) process for approval of SARS-CoV-2 tests is intended to be repealed with the introduction of the pre-market statutory instrument. Once Parliament agrees the statutory instrument, the MHRA have confirmed that the CTDA regulations will no longer apply from when the statutory instrument is made into legislation. They anticipate this…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

BIVDA response to articles concerning the UK’s private diagnostic testing market

Members will have seen articles from outlets including the BBC last week regarding the UK's private diagnostic testing market. BIVDA wishes to respond to these items. In Vitro Diagnostics are a key part of any health system. Before being placed on the market, tests are reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure they are safe…
Ben Kemp
July 29, 2025
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Media Monitoring: 17th – 23rd July

  Breakthrough Blood Test Detects Cancer Early and Forecasts Treatment Success In a recent publication, a research team from Cambridge and Proteotype Diagnostics unveiled a blood test that detects cancer early and predicts treatment response by decoding immune system signals rather than relying on tumour DNA. Published in a seminal paper titled "Immunodiagnostic plasma amino acid residue biomarkers detect cancer…
Ben Kemp
July 22, 2025
HighlightsHighlights Archive

Global aid cuts to accelerate AMR deaths and economic impact by 2050

Drug-resistant infections could claim millions more lives and severely damage the global economy by 2050, according to new modelling. The study, funded by the UK government and conducted by the Center for Global Development, warns that antimicrobial resistance (AMR) could reduce global GDP by $1.7 trillion annually if no action is taken. Major economies such as the US, UK, and…
Ben Kemp
July 22, 2025
Membership NewsMembership News Archive

Register for CPI’s Innovation in MedTech and Diagnostics Conference 2025: Connecting the Ecosystem

BIVDA members CPI are holding their two-day MedTech and Diagnostics Conference 2025: Connecting the Ecosystem on Tuesday 21 October 2025 at 09:00. The conference will explore the future of diagnostics and healthcare delivery in the UK, spotlighting the nation’s strengths in NHS clinical excellence, innovative R&D, and advanced wound care. The agenda features keynote presentations on the next decade of…
Ben Kemp
July 22, 2025
HighlightsHighlights Archive

PM launches ‘Diagnosis Connect’ to link newly diagnosed patients with charities

Hundreds of thousands of people diagnosed with long-term health conditions will receive extra help and support from expert charities, under a new service announced by the Prime Minister. Diagnosis Connect will ensure patients are referred directly to trusted charities and support organisations as soon as they are diagnosed — providing personalised advice, information and guidance to help them manage their…
Ben Kemp
July 22, 2025
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NHSE launch Social Value Playbook and seek feedback on April 2027 milestone of the Supplier Roadmap

NHSE are seeking views towards the next milestone of the NHS Supplier Roadmap. The development of the roadmap has been a collaborative effort, setting the NHS on the path toward the 2045 net zero target, as outlined in the Delivering a Net Zero National Health Service report. NHS England is now seeking feedback on the draft technical approach for scope 3…
Ben Kemp
July 22, 2025
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