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Ben Kemp

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‘Groundbreaking’ dementia blood test trial underway

A major new clinical study aimed at improving dementia diagnosis through blood testing has launched in Surrey, according to a leading charity. The initiative, spearheaded by researchers at Dementias Platform UK (DPUK), is supported by the Alzheimer’s Society, which says the trial seeks to close diagnostic gaps and improve the early identification of dementia. Known as the Blood Biomarker Challenge,…
Ben Kemp
May 6, 2025
Membership NewsMembership News Archive

MHRA fees increase update and action required in DORS

The MHRA have provided an regarding increases in MHRA fees. As outlined in their consultation response in March 2025, the existing one-off medical devices registration fee will rise from £240 to £261 per payable application in DORS. It is expected that this increase will come into effect in Q1 of the financial year 2025/2026. The MHRA has recommended that companies begin preparing for the fee…
Ben Kemp
May 6, 2025
ConsultationsConsultations ArchiveMembership NewsMembership News Archive

Reminder: Research and Development tax relief advance clearances consultation

Only a few weeks to go until the government's R&D tax relief advance clearances consultation closes. The consultation explores introducing clearances for R&D tax reliefs to reduce error and fraud, enhance certainty, and improve customer experience. The government seeks feedback on whether such a system would achieve these goals and which design or approach would be most effective. R&D Tax…
Ben Kemp
May 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Invitation: TEAM-NB IVDR Technical Documentation Training for Manufacturers – 3 July 2025

Team NB are running a training session aimed at manufacturers requiring EU Conformity Assessment. Team NB represents a number of EU Notified Bodies and works to harmonise the approach taken by the notified bodies when conducting conformity assessments. Sign-up for the 3rd July event here.
Ben Kemp
May 1, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EUDAMED Plalyground User Guide Updates 20250425

EUDAMED Playground User guide for the UDI Devices module is updated to 3.0.11 as below - Legacy Device Registration: EUDAMED user guide - UDI Device: EUDAMED user guide - Registration of Old/custom-made devices in the Vigilance module: EUDAMED user guide - Vigilance for EOs: EUDAMED user guide - Market Surveillance: EUDAMED user guide
Ben Kemp
May 1, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Biocides: EU active substance expiry dates

EU active substance expiry dates postponed Active substance expiry dates postponed whilst the renewal evaluation is completed in the EU. From 30 June 2025 to 31 December 2027 Copper sulphate pentahydrate (CAS 7758-99-8 EC 231-847-6) in product type 2 Benzoic acid (CAS 65-85-0 EC 200-618-2) in product types 3 and 4 3-iodo-2-propynylbutylcarbamate (IPBC) (CAS 55406-53-6 EC 259-627-5) in product type…
Ben Kemp
May 1, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

HRA Now – updates to model agreements

Dear members, UK Health Research Authority has updated a number of its model clinical trial agreements as below, and the new versions will apply to trials in all four nations (England, Wales, Scotland, and Northern Ireland) from 28th April 2025. IRAS Help - Preparing & submitting applications - Templates for supporting documents
Ben Kemp
May 1, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 28 April)

AI-assisted vs human-only evidence review Page summary: An exercise to investigate the robustness and reliability of using generative AI to help produce evidence reviews, compared to those only using human input. Change made: First published. Time updated: 10:00am, 23 April 2025 UK-Japan data adequacy: joint statement Page summary: Joint statement from a meeting with Commissioner Shuhei Ohshima and Chris Bryant.…
Ben Kemp
May 1, 2025
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