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In Vitro Diagnostic Medical Devices Regulation

The In Vitro Medical Devices Regulation (IVDR) has been in place since 26 May 2022. This webpage covers topics that are specific to the IVDR, including transitional provisions.

For more information on topics that apply to both the MDR and the IVDR, please see Common aspects of the regulations.

For more information on topics that apply only to the MDR, please see our MDR webpage.

IVDR transitional provisions

Qualification and classification of IVDs



Performance studies



European Union Reference Laboratories (EURLs)

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Date Printed: 05/02/2023