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Insights
Insights
Trend reporting in IVDR context and Requirements
11 May 2022
IVDR
Introduction: Manufacturers of devices, made available on the Union market, ...
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IVDR: Latest plan of action from MDCG
19 April 2022
IVDR
Set A – Essential ...
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Is your Diagnostic State-of-Art? Are you sure & you think you can convince you NB?
24 February 2022
IVDR
You being "SURE", or your company thinks their Products have SOA does not help as it needs to be ...
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MHRA: Registration requirements for IVDs
10 June 2021
IVDR
The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated the guidance on ...
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Is your Diagnostic State-of-Art?
1 March 2021
IVDR
Are you sure from IVDR perspective ? You being “SURE”, or your company thinks their ...
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IVD Clinical Performance Studies for FDA & EU
2 June 2020
IVDR
At present, the regulatory discussion pretty much focuses on MDR Regulation (EU) 2017/745 on ...
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