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.
Qualification and classification of IVDs
Learn more about how to qualify and classify IVDs.
Learn more