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that the current CTDA (Coronavirus Test Device Approvals) process for approval of SARS-CoV-2 tests is intended to be repealed with the introduction of the pre-market statutory instrument.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

Commission Implementing Decision (EU) 2025/1324 setting up an expert panel for paediatrics and rare diseases

Please be advised that two new EU expert groups for medical devices including IVDs are to be established for Paediatrics and for Rare diseases. These will be established and organised by EMA. Interesting to see where Rare diseases and Paediatrics cross over as most rare diseases are detected, and have most opportunity to be impacted in paediatrics. MedTech Europe are…
Ben Kemp
July 10, 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
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