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Regulatory Affairs Newsletter Archive

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

Brexit Updates – WC 24 Nov

UK Societas Page summary: Information on the administration and management of a UK Societas. Change made: Updated in line with changes to company registers and the launch of mandatory identity verification. Time updated: 12:01am, 18 November 2025 Interministerial Group on UK-EU Relations Communiqué: 12 May 2025 Page summary: The Interministerial Group on UK-EU Relations met on 12 May 2025. The…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs – WC 24 Nov

New law bans plastic wet wipes to protect rivers and seas Page summary: New law will ban the supply and sale of wet wipes containing plastic in England Change made: First published. Time updated: 11:10am, 18 November 2025 APHA Weybridge: general testing form (LSW008) Page summary: Submit samples to the Animal and Plant Health Agency (APHA) for commercial testing by…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade – WC 24 Nov

Pan-Euro Mediterranean Convention on Rules of Origin (PEM) Page summary: The Department for Business and Trade (DBT) is seeking views on the potential impacts of UK accession to the Regional Convention on Pan-Euro Mediterranean Convention on Rules of Origin (PEM). Change made: First published. Time updated: 12:00pm, 17 November 2025 UK considers joining agreement to boost trade opportunities for British…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Update – WC 24 Nov

APHA Weybridge: general testing form (LSW008) Page summary: Submit samples to the Animal and Plant Health Agency (APHA) for commercial testing by APHA Scientific. Change made: Updated the general testing form for APHA Weybridge (LSW008). Time updated: 12:09pm, 18 November 2025 Export: APHA animal disease testing Page summary: Use this form to submit samples from animals for laboratory testing to…
Ben Kemp
December 5, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Highly Pathogenic Avian Influenza: Argentina update

Highly Pathogenic Avian Influenza (HPAI) disease-free status: Argentina Defra has announced that, following an assessment, Great Britain has lifted the import restrictions that were implemented in August 2025 due to an outbreak of HPAI in Argentina. This means that: imports of poultry, ratite and wild game bird meat may resume the treatment category for relevant meat products has been amended…
Ben Kemp
December 5, 2025
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
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Position paper on Digital Label for importer and authorised representative published as a joint paper

Dear Members, please see below link to the MedTech Europe Position Paper on digital labelling. This is part of the ongoing advocacy to promote the adoption digital labelling as part of the reforms to the IVDR/MDR. Digital label for authorised representative and importer - MedTech Europe
Ben Kemp
November 13, 2025
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