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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

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that the current CTDA (Coronavirus Test Device Approvals) process for approval of SARS-CoV-2 tests is intended to be repealed with the introduction of the pre-market statutory instrument.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
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

ECHA public consultations: call for comments

Dear members, if the EU CLP consultation impacts substances that are in your products, remember to let me know at regulatory@bivda.org.uk ECHA public consultations: call for comments Deadline: 15 August 2025 The Great Britain mandatory classification and labelling (GB MCL) process includes the consideration of information gathered from public consultations, conducted by HSE or international bodies such as the European…
Ben Kemp
July 10, 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 7 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: AI Airlock webinar recording link added. Time updated: 4:31pm, 1 July 2025 Field Safety Notices: 23 to 27 June 2025 Page summary: List of…
Ben Kemp
July 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Update (WC 7 July)

World-first AI system to warn of NHS patient safety concerns Page summary: Pioneering AI technology will be developed to scan NHS systems to flag safety issues in real time and trigger crucial inspections earlier Change made: First published. Time updated: 5:35am, 30 June 2025 'Innovator passports’ set to accelerate cutting-edge NHS care Page summary: New ‘innovator passport’ will slash red…
Ben Kemp
July 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs Update (WC 7 July)

David Hill appointed as Interim Defra Permanent Secretary Page summary: David Hill will lead the department as the recruitment process for a Permanent Secretary continues. Change made: First published. Time updated: 10:35am, 30 June 2025 Extended Producer Responsibility for Packaging: 2025 base fees Page summary: Base fees for year 1 (2025 to 2026) of Extended Producer Responsibility (EPR) for packaging. Change made:…
Ben Kemp
July 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 7 July)

Businesses and consumers to benefit as Minister visits Taiwan Page summary: The Minister is in Taiwan for the 27th round of annual UK-Taiwan trade talks. Change made: First published. Time updated: 12:01am, 29 June 2025 UK support to Ukraine: factsheet Page summary: This factsheet summarises how the UK is supporting Ukraine following the Russian invasion. Change made: Factsheet reviewed and…
Ben Kemp
July 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 7 July)

A year in metascience (2025) Page summary: Report outlining the first year of the Metascience Unit, with evidence and insights on how to improve the UK’s research and innovation funding system. Change made: First published. Time updated: 8:45am, 30 June 2025 DSIT cyber security newsletter – June 2025 Page summary: The June 2025 edition of the DSIT cyber security newsletter.…
Ben Kemp
July 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Medical devices: list of UK approved bodies – Update

Medical devices: list of UK approved bodies Page summary: Details of the organisations that are currently approved to undertake conformity assessments on medical devices. Change made: Updated entry for TUV SUD BABT Unlimited (0168) to include:In-Vitro Diagnostic Medical Devices (designation expires on 2 July 2030)Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO…
Ben Kemp
July 10, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Register medical devices to place on the market

Register medical devices to place on the market Page summary: How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland. Change made: Increase to statutory fee effective 16 July 2025. Time updated: 1:59pm, 3 July 2025
Ben Kemp
July 10, 2025
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