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IVDR, MDR

EMA advice on high-risk medical device clinical development

The European Medicines Agency (EMA), in collaboration with the European Commission, has established a standard procedure for manufacturers of certain high-risk medical devices to request…

February 14, 2025
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Simona Varrella 2025-02-14T08:43:20+01:00
IVDR

Expert panel on classification of COVID-19 tests

The European Commission just published the advice on IVDs testing SARS-CoV-2 issued by the IVDR Expert Panel from the European Medicines Agency (EMA). The document…

January 31, 2025
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Simona Varrella 2025-01-31T11:55:39+01:00

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