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Ben Kemp

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MHRA Fees Update

BIVDA have been invited to attend a briefing by the MHRA next week under Trusted Advisor principles on the future revision of the MHRA fee structure. Details will follow when we are allowed to share them, and hope more information will be made public before the next scheduled UKCA Subgroup meeting on Tuesday 27th May.
Ben Kemp
May 13, 2025
HighlightsHighlights Archive

Government-backing for growth clusters set to benefit life sciences spinouts

Four innovative UK hubs across Merseyside, East Anglia, the Midlands, and Northeast England have received fresh backing to grow more ‘spinouts’, part of the the Government's Plan for Change. The Government recognises that while UK innovators have made great strides in getting bright ideas onto the market and in front of investors, red tape, talent shortages and a lack of…
Ben Kemp
May 12, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Register for #ModSim2025 before June 30 to SAVE!

 Industry's Premier Event for CM&S Innovation  Register Before June 30 & Save BIG! In an era where AI and computational modeling are reshaping medical device development, credibility is key. The 2025 Symposium on Computational Modeling and Simulation brings together industry leaders, regulators, and researchers to advance trusted, validated models that support safer, more effective medical technologies. Join us at #ModSim2025 to explore cutting-edge solutions, enhance regulatory confidence,…
Ben Kemp
May 9, 2025
FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA announces more frequent inspections and unannounced audits of foreign manufacturing facilities

FDA announces more frequent inspections and unannounced audits of foreign manufacturing facilities. There is also discussion on charging higher fees for foreign inspections, to help promote the move to US domestic manufacture. https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities  
Ben Kemp
May 9, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Register now: EU webinar on non-communicable diseases

Register now: EU webinar on non-communicable diseases Friday 16 May 2025, 10.00-13.00 Non-communicable diseases (NCDs) such as cardiovascular diseases, diabetes, chronic respiratory diseases, mental disorders, neurological disorders, or cancer are responsible for 80% of the disease burden in the EU Member States and the leading causes of avoidable premature deaths. The human and financial costs of NCDs are high and…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU MIR form updated to version 7.3.1

Dear Members, please be advised that the MDCG have updated the Manufacturer Incident Reporting form (MIR form) to version 7.3.1 which will become mandatory from November 2025 (6 month transition). This includes updates for machine to machine data transfers. View article... Note 1 : the form is not compatible with EUDAMED, and can not be used to generate XML output…
Ben Kemp
May 9, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU IVDR Harmonization request updated

Dear Members, please be advised the MDCG have updated the EU IVD Regulation standards harmonisation request to include two updated European standards EN 556-1:2024 - Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” - Part 1: Requirements for terminally sterilized medical devices EN556-2:2024 - Sterilization of medical devices - Requirements for medical devices to be…
Ben Kemp
May 9, 2025
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