| Theme | Application/notification for performance studies |
| Target Audience | Sponsors, Competent authorities |
| Products concerned | IVD |
| Regulatory reference |
IVDR (EU) 2017/746 Article 66 Article 69 Article 70(1) |
| Documents mentioned | MDCG 2022-12 |
As the EUDAMED database is not yet fully functional, the sponsor of a performance study may not submit an application through the dedicated electronic system.
A series of documents have been created to introduce and submit a performance study application to the Member State(s) in which the study is to be carried out according to the procedure described in the IVD Regulation.
However, the MDCG reminds that the use of these forms is voluntary and that national requirements specific to the Member State in which the performance study is to be conducted may apply.