2021-4 Q&A on Class D IVD during transition period
IVDR Notified Body ...

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Last Updated	13 April 2021
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2021-3 Q&A on custom-made devices
MDR CMD ...

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Last Updated	13 April 2021
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2021-2 COVID-19 rapid antibody tests
IVD 98/79/EC ...

Size	304.72 KB
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Last Updated	13 April 2021
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2021-1 Administrative practices until EUDAMED is fully functional
MDR IVDR SRN ...

Size	609.97 KB
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Last Updated	13 April 2021
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2020-18 UDI on Spectacle lenses & ready readers
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Size	175.42 KB
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Last Updated	17 December 2020
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2020-17 Q&A related to MDCG 2020-4
COVID-19 Audit temporary extraordinary measures ...

Size	101.89 KB
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Last Updated	17 December 2020
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2020-16 Guidance classification IVDR
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Last Updated	25 November 2020
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2020-15 Position paper actor registration module
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Size	88.74 KB
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Last Updated	19 August 2020
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2020-14 Guidance on MDSAP audit reports
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Size	88.72 KB
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Last Updated	19 August 2020
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2020-13 Clinical evaluation assessment report template
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Size	262.13 KB
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Last Updated	20 July 2020
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