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