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.
Learn more
Qualification and classification of IVDs
Find out how to qualify IVDs and what are the classifications for them.
Learn more