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Ben Kemp

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Preferred Product Characteristics document for diagnostics for cellulitis

NIHR has released a draft document on Preferred Product Characteristics for Diagnostic Cellulitis Technology for consultation. It closes at 23:59 on 18 November 2025. The draft document has been created by a diverse group of clinicians, patients and carers, researchers and experts who have come together to outline their ideal characteristics of a diagnostic health technology for cellulitis. By sharing…
Ben Kemp
November 4, 2025
HighlightsHighlights Archive

Thousands with undiagnosed hepatitis and HIV found in A&E testing

The UK Health Security Agency (UKHSA) has published an evaluation of the NHS emergency department (ED) opt-out testing programme for bloodborne viruses (BBVs) — HIV, hepatitis B (HBV), and hepatitis C (HCV). The initiative, running in 34 EDs across high HIV-prevalence areas, automatically tests patients for BBVs as part of routine bloodwork unless they opt out. Over its first 33…
Ben Kemp
November 4, 2025
Membership NewsMembership News Archive

Urgent: Attend the UK-India Medical Devices roundtable in Parliament on 13 Nov 2025

The Indo British Business Forum (IBBF) is extending their invitation to the exclusive UK–India Medical Devices, Medical Disposables, MedTech Roundtable taking place in Parliament on 13th November 2025 between 5:00 PM - 7:00 PM to BIVDA members. BIVDA are a partner for the event and would be delighted to have the participation of members. There are only a small number…
Ben Kemp
November 4, 2025
Funding OpportunitiesMembership NewsMembership News Archive

New funding round launches: LSIMF and Biomedical Catalyst 2025

Three new rounds of funding have been launched or announced in the last few days which may be of interest to members. The Life Sciences Innovative Manufacturing Fund (LSIMF) - Round 5 Closes: 28th November 2025 at 12 PM The Life Sciences Innovative Manufacturing Fund (LSIMF) is a capital grants fund which aims to build resilience for future health emergencies…
Ben Kemp
November 4, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

ISO 13485:2016 reconfirmed

Please be advised that ISO TC210 have reconfirmed ISO13485:2016 until 2030. Note that ISO 9000 QMS – fundamentals and vocabulary will be updated to ISO9000:2026 and this will have a impact on ISO13485 as a normative reference, but the core requirements of ISO 13485:2016 will remain.
Ben Kemp
October 31, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU UDI and UDI EUDAMED module updates

📌 On 29 October 2025, a new meeting of the Subgroup on Unique Device Identification (UDI, WG 9) of the Medical Device Coordination Group (MDCG) takes place, in its sessions for Competent Authorities only, and with the Stakeholders also. 👉 The draft Agendas, working documents and subsequent minutes are going to be made publicly available on the "Register of Commission…
Ben Kemp
October 31, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU MIR 7.3.1 update

The European Commission is planning another MIR 7.3.1 form update to make signature optional (as well as improvements in other remaining issues) which should be published soon somewhere in November. They have also extended the transition timeline for the mandatory implementation of the MIR 7.3.1 form for 4 months after the latest update (counting from the latest update to be…
Ben Kemp
October 31, 2025
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