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Regulatory Affairs Newsletter Archive

UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 14 Aug)

Please note this is an extract of the original bulletin. UKHSA priorities in 2023 to 2024 Page summary: Letter from Health Minister Maria Caulfield MP confirming the UK Health Security Agency’s role and priorities for the financial year 2023 to 2024. Change made: First published. £210 million to tackle deadly antimicrobial resistance Page summary: Up to £210 million of funding…
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August 25, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 14 Aug)

Please note this is an extract of the original bulletin. AI to help UK industries cut carbon emissions on path to net zero Page summary: New artificial intelligence (AI) solutions will accelerate industrial decarbonisation across the country, with nearly £4 million in government funding for green innovations. Change made: First published. Research Ventures Catalyst: open for applications Page summary: A…
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August 25, 2023
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveUncategorized

BIVDA publishes a position paper on Domestic Assurance

This week, BIVDA have published a position paper on domestic assurance routes to place IVD products on the Great Britain market. This paper presents the stance of the IVD industry in relation to domestic assurance and preferred routes to enter the British market. It highlights the considerations and recommendations to create well-structed market routes, with input provided by the BIVDA…
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August 25, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 14 Aug)

Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Published updated ‘COVID-19 test validation approved products’ data. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an…
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August 25, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA designates new UK Approved Bodies for Medical and IVD devices

The MHRA have increased their capacity to process conformity assessments for medical and IVD devices with the addition of TUV Rheinland UK Ltd and TUV SUD BABT Unlimited to their existing list of UK Approved Bodies. Approved bodies are organisations which the MHRA have designated to assess whether manufacturers and their medical devices meet the requirements set out in the UK…
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August 18, 2023
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

Team NB publishes a position paper on new MDR transition timelines and Notified Body capacity

Team-NB have published a position paper on the new MDR transition timelines and Notified Body capacity on 10 August. This paper outlines the members' views on the amended timelines with regards to benefits for the European patients and as the continuity in the availability of essential medical devices in the European market.
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August 18, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 07 Aug)

Please note this is an extract of the original bulletin. UK Trade Tariff: duty suspensions and autonomous tariff quotas Page summary: Temporary duty suspensions and autonomous tariff quotas for importing goods into the UK. Change made: ‘Apply for new duty suspension’ section updated as the 2023 application window is now closed. Notice to exporters 2023/15: Export Control Joint Unit Summer…
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August 18, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 07 Aug)

Please note this is an extract of the original bulletin. Experts to lead AI Safety Summit preparations as new funding announced to modernise healthcare Page summary: Two leading experts appointed to spearhead preparations for UK to host AI Safety Summit as £13 million unveiled to revolutionise healthcare research. Change made: First published.
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August 18, 2023
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