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Industry Clarification Statement DCB0129 - September 2023

This statement is to clarify that DCB0129 (often requested as part of DTAC) is not required for analysers and analytical platforms that are standalone, not embedded and are regulated in their own right as medical devices.
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BIVDA UKCA Sub-group policy paper: Labelling
BIVDA UKCA Sub-group policy paper: Labelling
02/06/2023
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In Vitro Diagnostic Test Procurement during the COVID-19 Pandemic
In Vitro Diagnostic Test Procurement during the COVID-19 Pandemic
15/05/2023
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Leveraging partnerships to realise the UK’s potential in genomics
Leveraging partnerships to realise the UK’s potential in genomics
15/05/2023
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Testing Times
Testing Times
22/09/2022
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Inflationary Price Pressures Industry Position Statement
Inflationary Price Pressures Industry Position Statement
08/07/2022
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Near Patient Testing - The Value Story
Near Patient Testing - The Value Story
09/04/2019
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Brexit: The Perspective of the in vitro diagnostics (IVD) industry - August 2018
Brexit: The Perspective of the in vitro diagnostics (IVD) industry - August 2018
16/08/2018
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Three simple tests could save the NHS at least £6.9 billion
Three simple tests could save the NHS at least £6.9 billion
19/06/2018
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