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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 visit our  Common aspects of the regulations webpage.

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

IVDR transitional provisions

Learn more about the transitional provisions of the IVDR.

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Qualification and classification of IVDs

Learn more about how to qualify and classify IVDs.

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Performance studies

Learn more about performance studies for IVDs.

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In-house IVDs

Learn more about in-house IVDs.

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