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Ben Kemp

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Value-based procurement pilots launched in thirteen NHS trusts

NHS England has launched pilots of a value-based procurement approach towards MedTech across thirteen trusts. Trusts such as Oxford University Hospitals NHS Foundation Trust will take part, with rollout across the NHS expected by early 2026. The NHS currently spends around £10 billion per year on MedTech, but has previously opted to buy tech based primarily on cost rather than…
Ben Kemp
September 30, 2025
Membership NewsMembership News Archive

BIVDA Market Audit for first half of 2025 released

The BIVDA Market Audit results for the first half of 2025 have been released to participating companies. The market audit shows strong growth in some areas versus 2024, with over 6% growth overall and over 7% without Coronavirus testing or diabetes management rapid testing (DMRT). Some disciplines continue to decline, however. The total value recorded is over £1.2bn covering 25…
Ben Kemp
September 30, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Now ‘Live’! Open Letter to EU Health Commissioner Olivér Várhelyi on IVDR and MDR

On 19 September 2025, together with 35 national associations, MedTech Europe has sent an open letter to European Commissioner for Health & Food Safety, Olivér Várhelyi, calling for urgent action to secure the availability of medical technologies for European citizens and health systems.
Ben Kemp
September 25, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Premarket to Postmarket: Navigate Global Cybersecurity Expectations with Confidence

Strategic Cybersecurity for Regulatory Success—Are You Aligned?   12 and 14 November 2025  •  9:00 AM - 5:00 PM ET  •  12.0 RAC Credits   Health authorities spanning the US, European Union, Australia, Canada, and Japan have issued cybersecurity guidance that is essential for regulatory affairs professionals to understand. In addition to premarket concerns, some of the guidance also includes…
Ben Kemp
September 25, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

UK NEQAS Microbiology and Parasitology webinar on POCT

UK NEQAS is holding a six-part pan-disciplinary webinar series Quality Standards in Point of Care Testing. The second webinar will take place on 1 October 2025 and registration is now open at https://us06web.zoom.us/webinar/register/WN_a1-uMaqNThitDqJ0F-k1OA The webinar will include the following presentations – Professor Peter L. Chiodini Malaria Antigen Rapid Diagnostic Tests, what a dipstick! With apologies to "Only Fools and Horses”…
Ben Kemp
September 25, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: GB active substance renewal submission deadlines

Apply for active substance renewal by the deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted at least 550 days before their expiry date. The 550-day deadlines are coming up for the following active substance/product type combinations under GB BPR: 27 December…
Ben Kemp
September 25, 2025
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