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Select all of the differences between IVDR and the prior EU regulatory framework ( IVDD ) Risk - based classification v . list - based

Select all of the differences between IVDR and the prior EU regulatory framework (IVDD) Risk-based classification v. list-based classification IVDD was based on a predetermined list of medical conditions or diseases while IVDR takes a more flexible approach without predetermined lists. IVDR creates multiple classes based on ascending risk to patients IVDD was more expensive for diagnostics companies IVDR requires post- marketing surveillance , while IVDD did not require post-marketing surveillance.

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