Amendments to a study with a medical device that may have a substantial impact on the safety, health or rights of the subjects, or on the robustness or reliability of the clinical data generated by the study, are considered substantial amendments and must be approved by the FAMHP and/or the EC before implementation.
The way of submitting amendments to studies with a medical device depends on the type of study and on the status of the medical device used in the study.
We refer to the FAMHP guidance which indicates for each type of study how a substantial amendment needs to be submitted.