Any substantial modifications having a significant impact on any aspect of research
The standard form 'Form of request for substantial modification' (Formulaire 3) is provided on the ANMS website in section: Formulaires et modèles à télécharger (Forms and Downloads).
From date of receipt of valid application
By silent (implicit) approval
By explicit authorization only for research relating to MD incorporating products of human or animal origin
(1) The contents of the dossier of request for authorisation of substantial modification are detailed in section 220.127.116.11 of the comprehensive guidance 'Avis au promoteurs/ Notice to sponsors'.
(2) 'Tome 3- Fiche pratiques' provides examples for substantial and non-substantial amendments as defined by ANSM
Both documents available on ANSM website in section: Activités > Dispositifs médicaux > Essais cliniques portant sur les dispositifs médicaux et dispositifs médicaux de diagnostic in vitro > Avis aux promoteurs / fiches (Notice to sponsors/ guidelines)
Articles R.1123-35 to 37 of the CSP
Decree Substantial Modification
ANSM may notify the applicant of its decision before the expiry of this 35 day deadline.
Submission format: Electronically (see Application Format). In exceptional circumstances, it is possible to transmit the file of request by post or messenger.