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Ben Kemp

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
Other Updates Regulatory Affairs NewsletterOther Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

UK Research and Innovation Weekly Digest Bulletin

Simple test could better predict risk of heart disease Researchers have shown that a combination of two lipoprotein markers, measured in a simple blood test, can give more accurate information about individual risk of heart disease than the current blood cholesterol test.   Where we live affects our health and how we age Research is showing how environmental factors such…
Ben Kemp
May 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 19 May)

Medical devices: post-market surveillance Page summary: Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Updated to provide the latest information regarding the MORE portal. Time updated: 12:08pm, 16 May 2025 Manufacturer’s Online Reporting Environment (MORE) Page summary: A a digital platform designed to facilitate the reporting,…
Ben Kemp
May 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates (WC 19 May)

Foot and Mouth disease controls eased for Germany Page summary: Personal imports for travellers from the EU remain banned Change made: First published. Time updated: 4:51pm, 14 May 2025 Foot and mouth disease: latest situation Page summary: Current cases of foot and mouth disease, trade restrictions and risk level. Change made: The restrictions on commercially importing from Germany have been…
Ben Kemp
May 23, 2025
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