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UK Government Updates Regulatory Affairs Newsletter Archive

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

November 2025 Med Tech Regs blog: Innovative approaches to Med Tech regulatory reform

November 2025 Med Tech Regs blog: Innovative approaches to Med Tech regulatory reform Joseph Burt, Head of Diagnostics and General Medical Devices Well, hello again.  Hasn’t time passed by so quickly since my last blog in September. At the MHRA, we have many exciting and pioneering initiatives underway. I was listening to a medical device podcast recently and the podcast…
Ben Kemp
December 5, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

BIVDA & MHRA UK MDR Classification Workshop – 4th December

Date and Time: Thursday 4th December, 11am to 3:30pm Make sure to register for BIVDA's workshop with the MHRA on the proposed classification rules, intended to be introduced under the Pre-Market SI. This is a crucial opportunity to work through the proposed IVD classification changes to the UK MDR with the MHRA and fellow BIVDA members. Members can register here.
Ben Kemp
November 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA update on EU MIR for Northern Ireland

Dear Members, I received the following feedback from MHRA regarding the EU MIR for Northern Ireland incident reporting to the EU IVD Regulation. ‘We have started accepting the current versions of MIR 7.3.1 as of Monday 03/11/2025 in respect to NI reporting. We will continue to accept EU MIR 7.2.1 until 7.3.1 becomes mandatory. We’ll be adding some guidance into…
Ben Kemp
November 13, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 10th Nov)

Rare therapies and UK regulatory considerations Page summary: A paper outlining MHRA’s intentions to make it quicker and easier to get rare disease therapies tested, manufactured and approved in the UK. Change made: First published. Time updated: 7:55am, 2 November 2025 Major change for rare disease treatments on way, signals MHRA Page summary: New paper sets out UK regulator’s intentions…
Ben Kemp
November 13, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DEFRA Updates (WC 10th Nov)

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 in Europe, 28 October 2025. Time updated: 3:30pm, 3 November 2025 Foot and mouth disease in North Africa and the Middle East Page summary: Preliminary outbreak assessment of the foot and mouth disease…
Ben Kemp
November 13, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 10th Nov)

Countering sanctions evasion: guidance for freight and shipping Page summary: For freight forwarders, carriers, hauliers, customs intermediaries, postal and express operators, and other companies facilitating the movement of goods. Change made: First published. Time updated: 12:06pm, 3 November 2025 Service and performance code for export licensing Page summary: Sets out the government’s service delivery objectives, commitments and targets for management…
Ben Kemp
November 13, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 10th Nov)

Public Switched Telephone Network charter Page summary: The Public Switched Telephone Network charter sets out a voluntary agreement between the government and communication providers to protect vulnerable people when they are moved onto digital services. Change made: Digital Space added to the list of signatories. Time updated: 1:54pm, 6 November 2025 UK Semiconductor Advisory Panel: Terms of Reference Page summary:…
Ben Kemp
November 13, 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 10th Nov)

Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated the lists for England and Scotland of professionals who can certify export health certificates. Time updated: 10:33am, 5 November 2025 Risk…
Ben Kemp
November 13, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 10th Nov)

Customs, VAT and excise UK transition legislation from 1 January 2021 Page summary: This collection brings together customs, VAT and excise EU Exit legislation and notices that have the force of law applicable to UK transition. Change made: The Customs Tariff (Preferential Trade Arrangements) (Amendment) Regulations 2025 added. Time updated: 3:34pm, 5 November 2025 Check if you can claim a…
Ben Kemp
November 13, 2025
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