|Theme||Eudamed2 – Clinical investigations|
|Target Audience||Competent authorities, clinical investigations sponsors|
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.