Eudamed
The European Eudamed portal is being developed for the registration of all relevant information regarding medical devices, including all clinical investigations with medical devices. The delivery of the clinical research module in Eudamed is expected for 2024. Until then, all clinical investigations with medical devices must be submitted through ToetsingOnline.
For registration in the future Eudamed, you are required to use the submission form with all relevant data about the investigation. As of May 26, 2021, this form is mandatory for clinical investigation with medical devices in the context of conformity purposes (MDR article 62/74.2).