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Ben Kemp

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NICE releases consultation on updated HealthTech Programme Manual

The National Institute for Health and Care Excellence (NICE) has opened a public consultation inviting feedback from external stakeholders on planned revisions to its HealthTech programme manual. These revisions outline the methodologies that the HealthTech programme will follow when producing guidance. A major change is the introduction of formalised procedures for reviewing technologies already in use within the NHS, referred…
Ben Kemp
August 13, 2025
Membership NewsMembership News Archive

National women’s health survey on UTI and prenatal screening urine tests launched

Precision urine specimen collection company and BIVDA member Forte Medical has launched a national survey to explore women’s experiences around Urinary Tract Infection and Prenatal Screening urine tests. The survey is designed to tease out issue around hygiene, dignity, repeat tests, antibiotic prescribing and side effects, repeat prescribing and more. If you, or a woman you know, have provided urine…
Ben Kemp
August 13, 2025
HighlightsHighlights Archive

New UKHSA Chief Executive Officer appointed

The government has announced the appointment of Professor Susan Hopkins as the new Chief Executive Officer of the UK Health Security Agency (UKHSA). Professor Hopkins expected to commence her new role in September. She will take over from acting CEO Dyfed Alsop, who will revert to being Chief Operating Officer of UKHSA. Professor Hopkins’ leadership will prove critical to UKHSA…
Ben Kemp
August 13, 2025
Membership NewsMembership News Archive

Showcase your innovation at a key NHS event, deadline: Thursday 21st August

Health Innovation East Midlands is offering innovators the chance to showcase their innovations to a local healthcare audience at a virtual Productivity Innovation Exchange event, taking place on Thursday 11 September, 10:00-11.30am They are looking for innovations that are ready to deploy and meet one or more of the following challenge statements. These have been identified through consultation with local…
Ben Kemp
August 13, 2025
HighlightsHighlights Archive

MHRA designated as WHO-Listed Authority

The Medicines and Healthcare products Regulatory Agency (MHRA) has been officially designated as a WHO-Listed Authority (WLA) by the World Health Organization, marking a pivotal achievement for UK life sciences and global health. This recognition affirms MHRA’s adherence to the highest international standards in regulating medical products, placing it amongst the world’s most trusted regulatory bodies, alongside Health Canada and…
Ben Kemp
August 13, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

TOPRA Symposium 2025: 30 September – 1 October, and Masterclass

TOPRA are holding their 2025 Symposium in Berlin from 30th September - 1st October. The event promises to cover some of the most important topics affecting IVDs and medical devices, particularly those affecting the EU. You can find the agenda and booking information here. Please find below information related to TOPRA's IVD masterclass later on this year. Regulation of In-Vitro…
Ben Kemp
August 13, 2025
Membership NewsMembership News Archive

BIVDA welcomes new member Life Sci Med Tech Ltd!

  BIVDA would like to wish a warm welcome to Life Sci Med Tech Ltd as the newest members of BIVDA! Life Sci Med Tech is committed to the goal of removing or reducing the current barriers to gynaecological screening procedures and holistically improve the experience and quality of women's healthcare. Products that are currently being researched: An optional speculum-free…
Ben Kemp
August 11, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Clinical Trials update – August 2025

New report published on simplified means of seeking and recording consent in clinical trials We’ve published the findings of a survey we ran earlier this year to understand people’s views on using simplified arrangements for consent in certain clinical trials. As part of the updated clinical trials regulations, sponsors will be allowed to use simplified arrangements for obtaining and evidencing…
Ben Kemp
August 6, 2025
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