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Ben Kemp

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How Carbon Credits supercharge your Net Zero commitments – BIVDA member webinar

Sustainability is now at the heart of public procurement tendering and is being driven by the NHS through policy to meet Environmental and Social Value requirements and targets. The NHS require all suppliers to have a Carbon Reduction Plan and to commit to reaching Net Zero. There is also a requirement to complete Evergreen and to deliver Social Value as…
Ben Kemp
May 27, 2025
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UK adopts historic Pandemic Agreement

Last week, the UK adopted a a new World Health Organization Pandemic Agreement alongside 124 other nations. The agreement aims to embed stronger domestic and global prevention by improving the way countries around the world work together to detect and combat pandemic threats. The new Pandemic Agreement seeks to help avoid excessive deaths and economic hardship witnessed during the COVID…
Ben Kemp
May 27, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Swissmedic have updated their guidance on vigilance reporting to reflect the EU introduction of MIR form ver 7.3.1

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 Kemp
May 23, 2025
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

WHO webinar: New guidance on WHO post-prequalification and post-EUL listing change applications for IVDs

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 Kemp
May 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Medical Devices (Amendment) (Great Britain) Regulations 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 Kemp
May 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

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 Kemp
May 23, 2025
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