Modifications of the research file (amendments)

Amendments to the research file

The review committee (accredited MREC or CCMO) usually takes note of minor amendments, such as textual corrections, for information purposes only. A further assessment by the review committee is required for substantial amendments, such as:

• a new participating centre;
• amendments that may have consequences for the safety of the study subject;
• amendments concerning the IVD.

Submitting an amendment

In the case of an amendment you are required to submit the following documents to the review committee:

• A signed cover letter (A1) with a description of the amendment(s) and an overview of all documents you are submitting;
• The amended and/or new documents listed in IVDR Annex XIII and XIV, possibly supplemented by a summary of the amendments per document (especially for protocol, IB and product information);
• A track-changes version of the modified documents;
• If the information in the ABR form (B1) changes substantively, you also need to create and submit a new version of the ABR form.
• A completed Eudamed form (B1a) for correct registration in Eudamed.

It is up to the review committee to determine whether a further assessment is required. Therefore, you do not need to report modifications to CCMO as competent authority.