Highly Pathogenic Avian Influenza import restrictions: Brazil On 15 May 2025, Brazil confirmed an outbreak of Highly Pathogenic Avian Influenza (HPAI) on a commercial breeding poultry farm in the state of Rio Grande do Sul. In response, Great Britain has temporarily suspended imports of the following avian commodities from the Brazilian state of Rio Grande do Sul for consignments produced…
Ben KempMay 28, 2025
Chemical list screening today is no longer just a compliance checkbox. It’s about navigating regulatory shifts and anticipating emerging concerns to enable safer and smarter sourcing and product decisions that are globally compliant. Join us on Tuesday 11 June for the first of a two-part webinar series on Strategic chemical list screening. In Part 1, we’ll focus on Compliance and…
Ben KempMay 28, 2025
Publication of GB mandatory classification and labelling (GB MCL) Agency Opinions The next batch of GB MCL Agency Opinions are now available for download. A GB MCL Agency Opinion formally proposes the GB mandatory classification and labelling for chemical substances, based on the scientific and technical assessment of the scientific data in line with the GB CLP Regulation, together with…
Ben KempMay 28, 2025
Just Published! POCT16, 1st Edition Emergency and Disaster Point-of-Care Testing In crises, every second counts. CLSI POCT16 delivers practical, step-by-step guidance for using point-of-care testing (POCT) devices in emergency, disaster, and urgent care settings—helping teams respond faster, more effectively, and with confidence. Streamlined protocols for high-stress environments Improve patient care during disasters and outbreaks Support regulatory readiness and…
Ben KempMay 28, 2025
Swissmedic have updated their guidance on vigilance reporting to reflect the EU introduction of MIR form ver 7.3.1 - www.bivda.org.uk/Portals/0/documents/Regulatory-Affairs/Misc%20docs/MU680_20_815e_WL_Guide_MIR_Manufacturer_Incident_Report_for_CH.pdf?ver=raJA0C2t47BhEDn4xJaWDA%3d%3d
Ben KempMay 23, 2025
New request for proposal! FIND are seeking a manufacturing partner for a lateral flow test reader for a multiplex semi-quantitative malaria test with a focus in low- and middle-income countries. Application deadline: 6 June 2025, 23:59 (CET) - Calls for partners - FIND
Ben KempMay 23, 2025
WHO recently published a revised guidance and application form for reporting changes to WHO prequalified and emergency use listed in vitro diagnostic (IVD) products. A webinar introducing the new guidance took place on 19 May 2025 and gathered over 120 participants. If you couldn’t attend the webinar but are interested in this subject, please access the webinar recording https://who.zoom.us/rec/share/omC-19wYnD1iXMZtP_qbYNmvfEMNBzsMLxl4cuSqEhpVrgoksqf2nLfrUw1IZhKS.VcSuOwaoh6vk1IirPasscode: 7YK=s?3=…
Ben KempMay 23, 2025
Baroness Merron and her team have successfully steered through The Medical Devices (Amendment) (Great Britain) Regulations 2025. This addresses the four pieces of EU legislation that supported the UK MDR 2002, which were due to sunset on 25th and 26th May 2025. This allows business as usual until the MHRA and DHSC can incorporate future updates into future UK, to align…
Ben KempMay 23, 2025
MHRA – New MORE Guidance on implementing the changing data requirements for medical device reporting
We have published new guidance to help medical device manufacturers prepare for changes to reporting requirements for serious safety incidents and field safety corrective actions in Great Britain. The new implementation guide for our Manufacturers Online Reporting Environment (MORE) clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025. Please…
Ben KempMay 23, 2025