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Ben Kemp

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UK researchers to create synthetic human genomes

A team of UK-based scientists are developing technology to create the first synthetic human chromosome. The ability to write large genomes has the potential to transform our understanding of human health, opening opportunities to develop cell therapies, climate-resistant crops and more. The Wellcome Trust is providing £10 million funding to the new Synthetic Human Genome Project (SynHG) to develop the foundational…
Ben Kemp
July 1, 2025
HighlightsHighlights ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes 2025 Business Plan

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Business Plan for 2025/26, reaffirming its commitment to keeping patients safe and enabling access to high quality and effective medical products through innovation across the UK. The plan appears forward-looking, acknowledging their purpose as an engine of economic growth and the need to be bold and ambitious in the…
Ben Kemp
July 1, 2025
HighlightsHighlights Archive

Womb test to assess miscarriage risk developed

University of Warwick scientists have developed a novel test which measures the health of a woman's womb lining to assess their risk of miscarriage. The womb lining plays an important role in developing the embryo. However, if the womb lining does not act as expected, it can lead to bleeding and loss of the baby. Once this occurs, women are…
Ben Kemp
July 1, 2025
HighlightsHighlights Archive

Medical and care technology part of growth directorate in NHS restructuring

Sir Jim Mackey, Chief Executive of NHS England, and Samantha Jones, DHSC Permanent Secretary, have jointly released plans to restructure NHS England as part of its gradual absorption into DHSC. Notably, 'medical and care technology' has been added to the newly formed Commercial and Growth Directorate General. This move aligns with the government's plans to link life sciences and health…
Ben Kemp
July 1, 2025
ConsultationsConsultations Archive

Suspected Sepsis – NICE Consultation

A reminder that the NICE consultation for the update of suspected sepsis: recognition, diagnosis and early management (NG51) closes on Friday 18th July 2025 at 5pm. Following stakeholder feedback, they have split the final version of this guideline by population. NG51 will be split into the following sections: •  NEWS2 populations (those aged 16 and over), •  Pregnant or recently pregnant people,…
Ben Kemp
June 30, 2025
HighlightsHighlights Archive

The Health Foundation critical on lack of investment for implementing healthcare innovation

In 2021, leading researchers at the Health Foundation mapped existing NHS innovation funding programmes.   Only 13% explicitly supported implementation. Subsequent analysis, such as the evaluation of the NHS AI Lab, identified too much central funding and support goes to new technology and pilots, not to their implementation. Re-running the mapping again in 2025, established adoption still loses out: Only 19%…
Ben Kemp
June 30, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU RoHS – 2025

Please be advised that Oko Institute, have been appointed as the external consultant to review the June 2025 batch of EU RoHS exemption pack renewals or refusals. If any of these Annex III or Annex IV exemptions are applicable see the table for interested registrants. MedTech Europe usually coordinate responses for the European MD/IVD market. Note that there will need…
Ben Kemp
June 26, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU Standardization – consultation responses by 21st July 2025

EU consultation on the harmonization of standards process. EU want feedback by 21st July. Member responses need to constructive rather than a whinge. Standardisation Regulation – revision And Erik Vollebregt’s commentary https://www.linkedin.com/posts/erikvollebregt_standardization-medicaldevices-invitrodiagnostics-activity-7343026050060238848-JDqs?utm_source=share&utm_medium=member_ios&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM I can send this out, but let me know if you want a BIVDA response (this directly impacts NI), and any specific text you’d like to included in…
Ben Kemp
June 26, 2025
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