Changes to the protocol of performance studies with in vitro diagnostic medical devices (IVD) are not subject to approval by the FAMHP.
However, the FAMHP wishes to be kept informed of any change in the protocol of performance studies with IVDs, and therefore asks manufacturers of IVDs or their legal representatives to forward this information electronically to the Research and Development (human use) department of the FAMHP. This can be done via the email address firstname.lastname@example.org or via the Common European Submission Platform (CESP). The following elements must be provided:
- cover letter - Subject: Amendment of performance study - IVDPSxxxxxx, specifying the title of the study and a summary of the changes made,
- the amended documents.
Notification of amendments is not subject to a fee and is therefore free of charge.