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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

Information on the transitional provisions of the IVDR including what they apply to.

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Qualification and classification of IVDs

Find out how to qualify IVDs and what are the classifications for them.

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Performance studies

Guidance and information on carrying performance studies for IVDs.

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In-house IVDs

A guidance document and webinar on the requirements for in-house IVDs.

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