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

Your chance to shape the UK’s connected future in new SEPs consultation

Your chance to shape the UK's connected future in new SEPs consultation The IPO has launched a consultation on Standard Essential Patents (SEPs) to boost UK innovation and help businesses navigate the complex world of connected technologies. The consultation, which runs until 7 October 2025, represents a critical step towards creating a more transparent and efficient SEPs ecosystem that works…
Ben Kemp
July 30, 2025
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DHSC’s Design for Life Industry Survey on Remanufacture of Class I Single-Use Medical Devices

DHSC has published its Design for Life Industry Survey exploring remanufacture of Class I medical devices for members to provide feedback. To recap the context, the survey is being conducted by the Design for Life programme at DHSC to explore the opportunities and implications of remanufactured single-use Class I medical devices for the GB market. The Design for Life Roadmap highlighted remanufacture…
Ben Kemp
July 22, 2025
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Reminder: Men’s Health Strategy

A reminder that the Men's Health Strategy consultation ends at 11:59pm on 17 July 2025. The government acknowledges that men face unique challenges throughout their lives, being disproportionately affected by health conditions, including cancer, cardiovascular disease and type 2 diabetes. While life expectancy data shows that men in England live on average four years less than women and suicide continues…
Ben Kemp
July 8, 2025
ConsultationsConsultations ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Clinical Trials update – June 2025

UK Health Research Authority are requesting feedback by 10th September on guidance to the new Clinical Trials Regulation. Note that the new regulation applies to medicinal products, however clinical trials involving combination products, or using IVDs are in scope, although you have to hunt through the Guidance and find the reference to: Combined trials of an investigational medicinal product and…
Ben Kemp
July 4, 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
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Pathology Managed Services Policy Guidance Development – DHSC Call for Evidence launched

Many of you will be aware of the work undertaken by BIVDA and members over the last six months to make the case to DHSC for improving the approach to the procurement of Pathology Managed Services in the NHS. This has now culminated in a "call for evidence" launched last week by DHSC. This call for evidence will be the…
Ben Kemp
June 16, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

WHO consultation: Defining the term “diagnostics”

WHO invites stakeholders to participate in this important consultation on the definition of the term “diagnostics.” This public consultation seeks to gather input from experts and stakeholders on the term “Diagnostics,” which currently has no official definition within WHO. While related definitions exist in WHO publications and other international references, none comprehensively encompass all types of diagnostics. Your feedback will…
Ben Kemp
May 14, 2025
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Reminder: Research and Development tax relief advance clearances consultation

Only a few weeks to go until the government's R&D tax relief advance clearances consultation closes. The consultation explores introducing clearances for R&D tax reliefs to reduce error and fraud, enhance certainty, and improve customer experience. The government seeks feedback on whether such a system would achieve these goals and which design or approach would be most effective. R&D Tax…
Ben Kemp
May 6, 2025
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