Skip to main content
search
Category

UK Government Updates Regulatory Affairs Newsletter Archive

Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Amendment to law to help remove misleading self-tests from shelves

Amendments to the Devices Law on “Misleading or Unsubstantiated Claims” have been enacted by the MHRA following a lengthy investigation by the NIHR Biomedical Research Centre: Birmingham Diagnostic team. The amendment will remove tests from the market that mislead users regarding intended use, safety, or performance; when supporting evidence is inadequate or when it fails to inform of significant risk,…
Ben Kemp
May 26, 2026
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

BIVDA Survey: provide views on medical devices regulations

DHSC has launched a request for stakeholder input as part of its statutory report under the Medicines and Medical Devices Act 2021. This report assesses how the regulations made under the Act are operating in practice. BIVDA has been invited to coordinate a sector response, and the UKCA Subgroup will be used to collate industry views where possible. We are…
Ben Kemp
May 12, 2026
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes draft Pre-Market Statutory Instrument and seeks views via survey

BIVDA broadly welcomes the publication of the draft Pre-Market Statutory Instrument on the WTO website by the MHRA. This draft SI provides an important indication of the future direction of the UK Medical Devices Regulations and demonstrates continued progress towards greater international harmonisation. We recognise the significant effort that has gone into reaching this stage and welcome the collaborative and…
Ben Kemp
May 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

EN ISO/IEC 42001:2026

Dear Members, please be advised that the following standards has been adopted by CEN/CENELC as an EU standard. It will also be adopted as a British Standard. This is separate from any future harmonisation to the EU MDR/IVDR. EN ISO/IEC 42001:2026 - Information technology - Artificial intelligence - Management system (ISO/IEC 42001:2023) (publication date=2026-03-18) View article...
admin
March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Foot and Mouth Disease (FMD): Greece

Dear Members, The UK is restricting imports of certain products from Greece because of the presence of Foot and Mouth Disease. This will include certain animal by-products which have not been adequately processed. Due to an outbreak of FMD in Greece, the import of the following commodities is now suspended: live (including non-domestic) ruminants and porcine animals, including wild game and…
admin
March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Update to UK Sanctions List: Russia Regime

Dear Members, please note the below updated list for UK Sanctions. Of note there are a couple of Banks listed not just individuals or companies. Today, Tuesday 17 March, the UK Government has varied 1 individual, corrected 3 entities and 1 individual and revoked (de-listed) 1 individual under the Russia sanctions regime. Varied Individual: Name Unique ID Viacheslav KANTOR RUS1127…
admin
March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Active substance renewal submission deadlines

Upcoming GB active substance renewal submission deadlines Apply for active substance renewal by the deadlines to keep products on the GB market. Under the GB Biocidal Products Regulation (GB BPR), active substance approvals will expire unless a renewal application is submitted to HSE at least 550 days before their expiry date. The 550-day deadlines are coming up for the following…
admin
March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates – WC 15th March

Clinical trials for medicines: apply for approval in the UK Page summary: How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry. Change made: Updated link to guidance for IMP+device trials. Time updated: 9:00am, 9 March 2026 Clinical trials that include an in vitro diagnostic device Page summary: Guidance on…
admin
March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates – WC 15th March

Export processed animal protein, including in mixtures and products, except for pet food to Turkey: certificate 7193 updated Page summary: Apply online to export processed animal proteins (PAP) derived from fish and poultry, including fishmeal, poultrymeal, poultry blood meal, feathermeal and compound feeds containing PAP to Turkey, but excluding finished pet food or products for human consumption. Change made: SUP…
admin
March 19, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates – WC 15th March

Businesses urged to take simple steps for smoother trade with the EU Page summary: Businesses are being urged to take simple steps to prepare for the landmark EU agri-food deal, that will cut costs, slash red tape and open up opportunities for exporters and importers. Change made: First published. Time updated: 12:01am, 9 March 2026 UK-India Free Trade Agreement: impact assessment Page summary: This impact assessment sets out the potential economic, sectoral, distributional and environmental impacts…
admin
March 19, 2026
Close Menu