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Regulatory Affairs Newsletter Archive

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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
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Takeaways from AI Impact Summit & The Philippines Join Global Regulatory Network

Takeaways from the AI Impact Summit 2026 and HealthAI Welcomes Newest Global Regulatory Network Member News from Manila and Notes from New Delhi: Towards a bolder, more inclusive future   Last month in New Delhi, I had the opportunity to attend the AI Impact Summit 2026, a milestone moment not only for global AI governance but also for the future…
admin
March 23, 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
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TEAM-NB IVDR Technical Documentation training for Manufacturers

Team NB are running a training course on EU IVDR Technical Documentation requirements for manufacturers. See below and attached IVDR Technical Documentation Training for Manufacturers On Thursday, 2026, July 2nd 9:00-17:00 CET (remotely) To register fill the form at the address: https://www.team-nb.org/manufacturertraining/ Link also available in NEWS: https://www.team-nb.org/new-session-ivdr-technical-documentation-training-for-manufacturers/
admin
March 19, 2026
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Therapeutic Goods (Information Specification – Database of Recalls, Product Alerts and Product Corrections) Instrument 2025

Dear Members, TGA have updated their information specification for their recalls and product alerts and corrections database. Therapeutic Goods (Information Specification – Database of Recalls, Product Alerts and Product Corrections) Instrument 2025 This Specification facilitates the release of specified therapeutic goods information held by the TGA in the database known as the Database of Recalls, Product Alerts and Product Corrections…
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
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