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MHRA Update from BIVDA’s 2025 Regulatory Affairs Seminar

BIVDA welcomed Dr Rob Reid and Nadine Neale from the MHRA to BIVDA's Regulatory Affairs Seminar last week. They provided updates on the latest MHRA activity including the MHRA Fees consultation, GB Post Market Surveillance, the Pre-Market SI Consultation, and the AI Airlock Pilot, which members will find useful. We have outlined all updates below: MHRA Fees Consultation – The…
Ben Kemp
February 19, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 10 Feb)

Current approaches to product marking Page summary: Guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors. Change made: First published. Time updated: 7:00am, 3 February 2025 MHRA asks for views on proposed guidance to support the safe regulation of new personalised cancer therapies   Page summary: The draft MHRA…
Ben Kemp
February 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 10 Feb)

Using harmonised standards for placing CE marked products on the GB market Page summary: If you rely on the continued recognition of EU requirements, including CE marking, and have used a harmonised standard without an identical GB designated standard, you may need to take specific actions. Change made: First published. Time updated: 7:00am, 3 February 2025 Current approaches to product…
Ben Kemp
February 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Energy Security and Net Zero Updates (WC 10 Feb)

Current approaches to product marking Page summary: Guidance on product marking, including the continued recognition of certain EU requirements, such as CE marking, for specific product sectors. Change made: First published. Time updated: 7:00am, 3 February 2025 Final UK greenhouse gas emissions statistics: 1990 to 2023 Page summary: Final estimates of UK territorial greenhouse gas emissions. Change made: First published.…
Ben Kemp
February 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 10 Feb)

Cyber security codes of practice Page summary: This page brings together the various DSIT codes of practice for cyber security. It explains who they are aimed at and how they align with Cyber Essentials. Change made: Page updated to reflect the new AI Cyber Security Code of practice. Time updated: 12:58pm, 3 February 2025 World-leading AI trial to tackle breast…
Ben Kemp
February 17, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Update (WC 10 Feb)

Designated standards: machinery Page summary: Notices of publication and a consolidated list for designated standards for machinery. Change made: Notice of publication amended and consolidated list updated. Time updated: 2:11pm, 3 February 2025 Safe and sustainable development of advanced materials Page summary: This journal article considers the benefits and barriers to the commercialisation of advanced materials. Change made: First published.…
Ben Kemp
February 17, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 10 Feb)

Apply to import multiple low value parcels on one declaration Page summary: You can use the bulk import reduced data set to declare one or more low value parcels in a single import declaration when you import goods into Great Britain. Change made: Updated the eligibility information in the sections ‘who can use the bulk import reduced data set’ and…
Ben Kemp
February 17, 2025
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LIVE Webinar: Decoding the EU AI Act

Tue, Mar 4, 2025 3:00 PM - 4:00 PM GMT The EU AI Act has significant implications for medical devices and in vitro diagnostics (IVD) incorporating artificial intelligence. Join our webinar to discover the latest insights on how to integrate the requirements of the Act in an efficient manner. The webinar consists of a 45-minute presentation and a live Q&A.…
Ben Kemp
February 17, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CI/PS coordinated assessment pilot officially launched

Please note that the European Commission has launched a dedicated website for clinical investigations and performance studies coordinated assessment pilot: Medical Devices - Clinical investigations and performance studies - European Commission and with this also officially opened the call for expression of interest for the Clinical Investigations (MD) pilot: Pilot coordinated assessment for CI/PS - European Commission For medical devices:…
Ben Kemp
February 14, 2025
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