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Ben Kemp

Sponge on a string test pilot rolled out in pharmacies HighlightsHighlights Archive

Sponge on a string test pilot rolled out in pharmacies

NHS England has announced the rollout of a 'sponge on a string' test in high street pharmacies. Aimed at those experiencing persistent heartburn or acid reflux, this two-year pilot hopes to prevent cases of oesophageal cancer. This rapid test takes just ten minutes and, once processed in a lab, can detect pre-cancerous changes in the oesophageal lining, known as Barrett's…
Ben Kemp
July 16, 2025
BIVDA welcomes replacement of Covid Test Device Approval Scheme Membership NewsMembership News Archive

BIVDA welcomes replacement of Covid Test Device Approval Scheme

BIVDA welcomes the replacement of Covid Test Device Approval Scheme. The Covid Test Device Approval (CTDA) was introduced during the pandemic as a measure to regulate an influx of new Covid-19 tests. Its retention post-Covid means any test on the UK market which tests for Covid – even as part of testing for other infections – still needs to pass…
Ben Kemp
July 16, 2025
Commission Implementing Decision (EU) 2025/1324 setting up an expert panel for paediatrics and rare diseases European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Commission Implementing Decision (EU) 2025/1324 setting up an expert panel for paediatrics and rare diseases

Please be advised that two new EU expert groups for medical devices including IVDs are to be established for Paediatrics and for Rare diseases. These will be established and organised by EMA. Interesting to see where Rare diseases and Paediatrics cross over as most rare diseases are detected, and have most opportunity to be impacted in paediatrics. MedTech Europe are…
Ben Kemp
July 10, 2025
MHRA PMS amendment GB regulations 2024 Standardised format for PSUR 202506 Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA PMS amendment GB regulations 2024 Standardised format for PSUR 202506

Please be advised that MHRA have published the Guidance on Standardised PSUR format. It is guidance, and members may exclude irrelevant sections or present data in formats different than in the guidance, but it identifies the data they expect to see in the PSUR submitted to meet the updated UK PMS SI requirements that applied from 16th June 2025. The format can…
Ben Kemp
July 10, 2025