Wednesday, May 21, 2025 | 9:00 AM 10:00 AM CST Join our subject matter experts, Allison Strochlic, Senior Research Director, Andrea Sutton, Research Director, and Petra Boeree, Lead Human Factors Specialist from Emergo by UL’s Human Factors Research & Design team on May 21, 2025 from 9:00 – 10:00 a.m. CST as they hold an open forum to answer your…
Ben KempMay 9, 2025
New rules for businesses in Britain posting parcels to Northern Ireland have come into effect. The changes are a consequence of Northern Ireland's post-Brexit deal known as the Windsor Framework. The major change is for business-to-business parcels which now require customs declarations. Parcel companies need to be signed up to a trusted trader scheme but individuals posting and receiving parcels should…
Ben KempMay 9, 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 KempMay 1, 2025
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 KempMay 1, 2025
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 KempMay 1, 2025
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 KempMay 1, 2025
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 KempMay 1, 2025