D1. Investigator’s Brochure (IB)
An Investigator's Brochure (IB) is a summary of the clinical and pre-clinical data on the IVD(s) that are relevant to the performance study of the IVD(s) in human subjects.
The requirements of the Investigator's Brochure for an IVD performance study are listed in Chapter I of Annex XIV of the IVDR and in Annex C of ISO20916 (2019).
For research files falling under IVDR article 70.1, it is sufficient to submit an Instruction For Use (IFU).