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UK Government Updates Regulatory Affairs Newsletter

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

MHRA Update (WC 28 July)

Medicines and Medical Devices Act 2021 – Stakeholder survey Page summary: We invite feedback on the operation and impact of the human medicines and medical devices legislation as part of a statutory review required under the Medicines and Medical Devices Act 2021. Change made: First published. Time updated: 9:10am, 21 July 2025 MHRA Performance Data Page summary: Performance data for…
Ben Kemp
August 4, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Border Trade Newsletter – getting it right at the border 24 07 25

IDM Change Monday 28th July - Impact on Logging on to Defra Services An Identity Management (IDM) change is scheduled for Monday 28th July, between 19:00 and 21:00 (BST). IDM is the system used to authenticate users when logging on to various Defra services., this includes access to IPAFFS and the ALVS Help Desk Tool. During the change window, there…
Ben Kemp
July 30, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Product Regulation and Metrology Act 2025

New Legislation - Product Regulation and Metrology Act 2025 An Act to make provision about the marketing or use of products in the United Kingdom; about units of measurement and the quantities in which goods are marketed in the United Kingdom; and for connected purposes. However IVDs and Animal By-products are exempt, but Veterinary use and Research Use Only products…
Ben Kemp
July 30, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Yellow Card centre launched in Northern Ireland to strengthen patient safety

Yellow Card centre launched in Northern Ireland to strengthen patient safety Page summary: A new regional centre to promote Yellow Card reporting has been launched in Belfast today. Change made: Updated to reflect that the Northern Ireland Adverse Incident Centre (NIAIC) incident and reporting function will be closing. From the 1st August 2025, healthcare professionals in Northern Ireland will report…
Ben Kemp
July 30, 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. 1) Regulations 2025

Dear Members, the The Data (Use and Access) Act 2025 (Commencement No. 1) Regulations 2025 has been published which brings into force as at 20th August 2025, large sections of the Data (Use and Access) Act 2025 published 19th June 2025. The Act covers access to customer data and business data, as well as: to make provision for the regulation…
Ben Kemp
July 30, 2025
ConsultationsConsultations ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Your chance to shape the UK’s connected future in new SEPs consultation

Your chance to shape the UK's connected future in new SEPs consultation The IPO has launched a consultation on Standard Essential Patents (SEPs) to boost UK innovation and help businesses navigate the complex world of connected technologies. The consultation, which runs until 7 October 2025, represents a critical step towards creating a more transparent and efficient SEPs ecosystem that works…
Ben Kemp
July 30, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Medicines and Healthcare products Regulatory Agency Update (WC 21 July)

AI Airlock: the regulatory sandbox for AIaMD Page summary: A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD). Change made: Update to reflect that the pilot phase of the AI Airlock is complete, and that applications for phase 2 have now closed Time updated:…
Ben Kemp
July 30, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

CTDA (Coronavirus Test Device Approvals) Update

The MHRA recently announced that the current CTDA (Coronavirus Test Device Approvals) process for approval of SARS-CoV-2 tests is intended to be repealed with the introduction of the pre-market statutory instrument. Once Parliament agrees the statutory instrument, the MHRA have confirmed that the CTDA regulations will no longer apply from when the statutory instrument is made into legislation. They anticipate this…
Ben Kemp
July 29, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA PMS amendment GB regulations 2024 Standardised format for PSUR 202506

Please be advised that MHRA have published the Guidance on Standardised PSUR format. It is guidance, and members may exclude irrelevant sections or present data in formats different than in the guidance, but it identifies the data they expect to see in the PSUR submitted to meet the updated UK PMS SI requirements that applied from 16th June 2025. The format can…
Ben Kemp
July 10, 2025
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