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Ben Kemp

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Biocides: EU active substance non-approval decisions and expiry date

Biocidal products must be phased off the NI market. Following evaluation/withdrawal of support under the EU Biocidal Products Regulation (EU BPR), a decision has been taken not to approve the following active substance/product type combinations. This will affect NI: 1,2-benzisothiazol-3(2H) - one (BIT) (CAS 2634-33-5 EC 220-120-9) in product type 2 Pyrithione zinc (CAS 13463-41-7 EC 236-671-3) in product types…
Ben Kemp
July 30, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New! Ensure Excellence in Molecular Testing with CLSI MM14

As molecular methods become essential in clinical diagnostics, the need for high-quality proficiency testing has never been greater. The brand new CLSI MM14—Design of Molecular Proficiency Testing/External Quality Assessment gives you the comprehensive guidance you need to establish or evaluate PT/EQA programs with confidence.   This essential resource covers: Creating reliable, high-quality PT/EQA schemes for molecular methods Best practices for…
Ben Kemp
July 30, 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
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
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