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Regulatory Affairs Newsletter

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HRA Review of 2024

Welcome to the final edition of HRA Latest for 2024. As we round off the year our Chief Executive, Matt Westmore, has written a blog reflecting on how the Health Research Authority has supported research in the UK throughout 2024. In the blog Matt also looks ahead to our new strategy and what our priorities will be in 2025. Read…
Ben Kemp
January 8, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Follow-up: MedTech Europe quarterly webinar for Partner Trade Associations

Dear Members, please see below link to the MedTech Europe Quarterly update. There is a significant focus on the review of the IVDR/MDR implementation. Following the MedTech Europe Quarterly Webinar held on 16 December 2024, please find below the link to watch the 30 minutes presentation held by our speakers, as well as the slide deck used during the meeting…
Ben Kemp
December 19, 2024
ConsultationsConsultations ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

The AI and Copyright Consultation has launched today

Today, the Intellectual Property Office (IPO), the Department of Culture, Media, and Sport (DCMS) and the Department for Science, Innovation and Technology (DSIT) launched the Consultation on Copyright and Artificial Intelligence. We welcome your views. The consultation will be open for responses from 17 December 2024 to 25 February 2025.  Please share the consultation widely – we need to hear…
Ben Kemp
December 19, 2024
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

COMBINE programme for clinical trials and medical devices endorsed by Member States

COMBINE programme for clinical trials and medical devices endorsed by Member States National authorities in Member States have endorsed a new strategy for the COMBINE programme, a cross-sector initiative to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme will be rolled out over the coming years through seven cross-sector projects. It aims to foster collaboration…
Ben Kemp
December 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Update (WC 16 Dec)

Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled. Change made: DEU/012/2023/002 & DEU/004/2023/003 moved to ‘List of medical devices that are no longer covered by an exceptional use authorisation’.DEU/011/2022/007 & DEU/012/2022/024 – extensions…
Ben Kemp
December 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Update (WC 16 Dec)

UK & Switzerland deepen science ties with £16 million backing Page summary: UK and Switzerland update science and research partnership to focus on some of today’s most pressing challenges, from healthcare to green energy. Change made: First published. Time updated: 12:01am, 9 December 2024 £100 million public-private health research boost Page summary: 20 new clinical research hubs to be set…
Ben Kemp
December 18, 2024
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 16 Dec)

Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards for businesses. Change made: Proposals to amend added for personal protective equipment (PPE) and low voltage equipment. Time updated: 11:26am, 11 December 2024 Electromagnetic Compatibility Regulations 2016 Page summary: Guidance for businesses. Change made: Guides revised following legislation to extend recognition of CE…
Ben Kemp
December 18, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 16 Dec)

Subsidy control principles assessment guides Page summary: Guides for public authorities to document whether a subsidy or a subsidy scheme is consistent with the UK subsidy control principles. Change made: First published. Time updated: 12:01pm, 9 December 2024 UK subsidy control regime Page summary: Guidance and information on the UK subsidy control regime. Change made: ‘Subsidy control principles assessment guides’…
Ben Kemp
December 18, 2024
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