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Ben Kemp

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Attend the UKHSA ‘The Future of Diagnostics’ event on Monday 1st December

As part of London Bio-Innovation Week, join UKHSA and Canary Wharf Life Sciences for insight and networking from leading diagnostics experts, including BIVDA's AMR expert Dr Jayne Ellis. The Future of Diagnostics with UKHSA and Canary Wharf Life Sciences UKHSA have teamed up with Canary Wharf Life Sciences to deliver this One Nucleus/BioInnovation Week Fringe event on diagnostics. The COVID-19…
Ben Kemp
November 25, 2025
Membership NewsMembership News Archive

Men’s Health Strategy unveiled by UK Government

The Government has launched England's first ever Men's Health Strategy today. Key takeaways for the diagnostics sector are commitments to: Invest £3 million over 3 years, starting in April 2026, into community-based men’s health programmes, designed to reach those most at risk and least likely to engage with traditional services. Explore opportunities to allow men to order relevant tests at…
Ben Kemp
November 25, 2025
Membership NewsMembership News Archive

DBT Webinars: China Medtech Unlocked: Opportunities for UK Life Sciences businesses

The UK Government's China Medtech Unlocked: Opportunities for UK Life Sciences Businesses webinar series is now online for registration. China offers significant commercial potential, but navigating its complexities requires informed strategies and strong networks. This series aims to help businesses with the critical insights, practical tools, and expert connections necessary for success. Upcoming Webinars in the Series: 05 Dec: Overview & Regulation…
Ben Kemp
November 24, 2025
Membership NewsMembership News Archive

BIVDA Spotlight: MeMed

This week, we are spotlighting MeMed, whose 15-minute test which distinguishes between a bacterial or viral infection is currently being trialled by the NHS. Who We Are MeMed is a global leader in host-immune response diagnostics. Our mission is to translate the immune system’s complex signals into simple, actionable insights that empower clinicians to make better infection-management decisions, helping to…
Ben Kemp
November 24, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA update on EU MIR for Northern Ireland

Dear Members, I received the following feedback from MHRA regarding the EU MIR for Northern Ireland incident reporting to the EU IVD Regulation. ‘We have started accepting the current versions of MIR 7.3.1 as of Monday 03/11/2025 in respect to NI reporting. We will continue to accept EU MIR 7.2.1 until 7.3.1 becomes mandatory. We’ll be adding some guidance into…
Ben Kemp
November 13, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Position paper on Digital Label for importer and authorised representative published as a joint paper

Dear Members, please see below link to the MedTech Europe Position Paper on digital labelling. This is part of the ongoing advocacy to promote the adoption digital labelling as part of the reforms to the IVDR/MDR. Digital label for authorised representative and importer - MedTech Europe
Ben Kemp
November 13, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MedTech Europe quarterly webinar for Partner Trade Associations around the World (Mon, 24 Nov, 3-4 pm CET)

On Monday, 24 Nov 2025 from 15:00 to 16:00 pm CET (Brussels time), MedTech Europe will host its next quarterly webinar regarding the implementation status of the EU In Vitro Diagnostic Medical Devices and Medical Devices Regulations (IVDR and MDR) for its partner medtech trade associations around the world. The webinar will be 60 minutes in duration including a 30-minute Q&A. Due to…
Ben Kemp
November 13, 2025
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