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Regulatory Affairs Newsletter Archive

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Update from GOV.UK for: Radio equipment regulations

Radio equipment regulations Page summary: Guidance for businesses on the Radio Equipment Regulations 2017 and Radio Equipment (Amendment) (Northern Ireland) Regulations 2024. Change made: New guide added on the Radio Equipment (Amendment) (Northern Ireland) Regulations 2024, and existing guides revised following legislation to extend recognition of CE marking on products being placed on the Great Britain market which came into…
Ben Kemp
January 8, 2025
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

IVDR/MDR implementation – EU Commission (GÖG) Survey – Please participate (Deadline 28/02/2025)

The European Commission continues to gather evidence of the impact of IVDR implementation, especially on manufactures plans to transition devices from IVD directive to IVD Regulation, or more importantly which devices manufacturers do not intend to transition. UK manufactures or subsidiaries who place product on the EU market including Northern Ireland are strongly encouraged to respond, noting that group companies…
Ben Kemp
January 8, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

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
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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
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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
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