| Theme | Eudamed2 – Clinical investigations |
| Target Audience | Competent authorities, clinical investigations sponsors |
| Products concerned |
MD |
| Documents mentioned |
MDR (EU) 2017/745 MDCG 2021-1 Rev.1. |
This guide provides Competent Authorities (CA) with the necessary instructions to obtain a “CIV-ID”, a unique identification number for clinical investigations in Eudamed2. The CIV-ID will facilitate communication between sponsors and CA and between CA in different Member States as well.