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Regulatory Affairs Newsletter Archive

Dynamic list of standards applicable to IVDs, in collaboration with BSI BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Dynamic list of standards applicable to IVDs, in collaboration with BSI

BIVDA have collaborated with BSI to develop a comprehensive list of relevant standards that relate to various aspects of IVD product development and manufacturing. We have worked jointly with BSI to compile this list of IVD Standards to help BIVDA members identify those standards relevant to IVD products and organisational needs. While the list aims to provide a clear and…
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September 1, 2023
Intertek designated as a UK Approved Body UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Intertek designated as a UK Approved Body

Recently MHRA announced the designation of TUV Rheinland UK Ltd and TUV SUD BABT Unlimited under the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). On 24 August, their webpage was updated again to add the designation of Intertek Medical Notified Body UK Ltd for medical devices. Approved bodies are organisations which the MHRA…
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August 25, 2023
DBT weekly update (WC 14 Aug) UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 14 Aug)

Please note this is an extract of the original bulletin. How to claim preferences under the Developing Countries Trading Scheme (DCTS) Page summary: This guidance outlines the requirements for claiming preferential tariffs under the Developing Countries Trading Scheme (DCTS). Change made: Removed importers knowledge from the list of types of proof of origin.
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August 25, 2023
DHSC weekly update (WC 14 Aug) 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
DSIT weekly update (WC 14 Aug) 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 publishes a position paper on Domestic Assurance 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