Eudamed
The European Eudamed portal is being developed for the registration of all relevant information regarding IVDs, including all information relating to IVD performance studies. Delivery of the clinical research and performance study module in Eudamed is expected for 2024. Until then, all IVD performance studies must be submitted through ToetsingOnline.
For registration in the future Eudamed, you are required to use the Eudamed form with all relevant data and information on the study.