Theme Notification of a substantial modification of clinical investigation
Target Audience Sponsor of a clinical investigation
Products concerned


Documents mentioned

MDR (EU) 2017/745

MDCG 2021-8

MDCG 2021-20

The sponsor of a clinical investigation is required to submit an application to the Member State in which a clinical investigation is to be conducted and to notify its intention to introduce substantial modification, via the EUDAMED database. Until EUDAMED is fully functional, the MDCG 2021-28 provides a template for notifying Competent Authorities of any substantial modification to a clinical investigation