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Ben Kemp

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

Medicines and Healthcare products Regulatory Agency Update (WC 21 July)

AI Airlock: the regulatory sandbox for AIaMD Page summary: A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD). Change made: Update to reflect that the pilot phase of the AI Airlock is complete, and that applications for phase 2 have now closed Time updated:…
Ben Kemp
July 30, 2025
HighlightsHighlights Archive

Media Monitoring: 24th – 30th July

  New Chief Executive of NHS Wales announced Jacqueline Totterdell has been appointed as the next Chief Executive of NHS Wales, succeeding Judith Paget, who will take on a new role as Director General for Strategy within the Welsh Government. Currently serving as Group Chief Executive Officer of St George’s, Epsom and St Helier University Hospitals and Health Group, Jacqueline brings…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

BIVDA welcome 52North as new members!

We are pleased to announce 52North - creators of Neutrocheck® as new BIVDA members! 52North is a medical technology company on a mission to make urgent care pathways safer and more effective. Awarded breakthrough status for its first product Neutrocheck® by the UK Government in 2024, 52North builds in vitro diagnostic and digital solutions to transform patient journeys in urgent care.…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

BIVDA member spotlight: Hugo Technology

Who we are Hugo Technology, founded in 2001, is a leading Independent Service Organisation (ISO) specialising exclusively in technical services and solutions support for medical and laboratory device/systems Original Equipment Manufacturers (OEMs). We’re not a third-party contractor, we partner directly with OEMs. We currently process more than 35,000 work orders per year. What we do With two state of the…
Ben Kemp
July 29, 2025
HighlightsHighlights Archive

Steve Bates leaves BIA to become OLS’s Executive Chair

Steve Bates has left his role as Chief Executive of the BioIndustry Association (BIA) after 13 years to become Executive Chair of the Office for Life Sciences (OLS). The Government says his appointment reflects its commitment to rapidly implementing the recently published Life Sciences Sector Plan. In his new role, Steve will act as an ambassador both domestically and internationally for…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

Medicines and Medical Devices Act 2021 – Stakeholder Survey

The Medicines and Healthcare products Regulatory Agency (MHRA), in collaboration with the Department of Health and Social Care (DHSC), is conducting a review of the UK’s medicines and medical device regulatory framework, and they are seeking input from stakeholders across the sector, including patients and the public. The review is a statutory obligation under the Medicines and Medical Devices Act 2021 and…
Ben Kemp
July 29, 2025
Membership NewsMembership News Archive

Innovate UK Health & MedTech Global Mission to Singapore 2025 – applications now open

Innovate UK’s Global Business Innovation Programme consists of a ‘Get ready’ preparation phase, 5-day innovation visit to Singapore focused on Health & Medical Technologies, an ‘Exploit the opportunity’ workshop and support from an Innovate UK innovation and growth specialist. All phases of the programme are aimed at helping your business maximise the opportunities identified and develop innovation projects with partners…
Ben Kemp
July 29, 2025
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