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Regulatory Affairs Newsletter

Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs Updates (WC 8th Sept)

Lumpy skin disease in Europe Page summary: Preliminary and updated outbreak assessments for lumpy skin disease in Europe. Change made: Added outbreak assessment for lumpy skin disease, August 2025. Time updated: 4:11pm, 1 September 2025 EM on amendments to EU chemicals legislation (COM(2025)386) Page summary: The government’s summary of a European Commission proposal to streamline assessments of chemicals across EU…
Ben Kemp
September 12, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 8th Sept)

New Horizon campaign to push UK as partner of choice to world’s top researchers Page summary: UK to launch campaign in Spain and Germany to encourage showcase the benefits of working with UK researchers and businesses through Horizon Europe. Change made: First published. Time updated: 9:00am, 3 September 2025 Investment in British AI companies hits record levels as Tech Sec…
Ben Kemp
September 12, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 8 Sept)

Create a goods movement reference Page summary: Get a goods movement reference to move goods through locations which use the Goods Vehicle Movement Service. Change made: Information has been updated to confirm you can now include multiple entry summary declarations for goods moving from the EU to Great Britain (England, Scotland and Wales) and from Great Britain to Northern Ireland.…
Ben Kemp
September 12, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Medical devices: post-market surveillance

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: Added link to guidance for ‘Medical Devices: Standardised format for post market surveillance report (PMSR)’ Time updated: 3:14pm, 5 September 2025
Ben Kemp
September 12, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Team NB – Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746

Please see the update from Team NB, the Version 2 of the Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. See also a useful comparison between version 1 and version 2. Team-NB-PositionPaper-BPG-IVDR-V1-20230225.docx → Team-NB TechDoc IVDR.pdf - Draftable
Ben Kemp
September 12, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The Data (Use and Access) Act 2025 (Commencement No. 2) Regulations 2025

The Data (Use and Access) Act 2025 (Commencement No. 2) Regulations 2025 These Regulations bring into force section 124 of the Data (Use and Access) Act 2025 (c. 18) (“the 2025 Act”). These are the second commencement regulations made under the Act. Data retention by internet services – death of a child.  
Ben Kemp
September 12, 2025
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Registration opened for BIVDA’s 2026 Regulatory Affairs Seminar

After last year’s record-breaking event, BIVDA is excited to hold the 2026 Regulatory Affairs Seminar, between 10–11 February in Birmingham. This year promises to be bigger than ever — unmissable for any regulatory affairs professional in diagnostics. Whether you’re driving innovation to market, steering post-market strategy, or hungry for expert insight into where UK regulations are heading, this seminar is…
Ben Kemp
September 9, 2025
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FDA fees 1st Oct 2025 to 30 Sep 2026

FDA have announced their user fess for financial year 2026. The fees will apply from 1st Oct 2025 until 30th Sep 2026. The FDA Annual Establishment Registration Fee stands at $11,423. Under the Small Business Determination (SBD) Program, small businesses able to demonstrate financial hardship according to FDA, the FDA has discretion to waive the annual establishment registration fee. This…
Ben Kemp
September 8, 2025
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