D1. Investigator’s Brochure (IB)
An Investigator's Brochure (IB) is a summary of the clinical and pre-clinical data on the investigational device(s) that are relevant to the clinical investigation of the investigational device(s) in human subjects.
The requirements of the Investigator's Brochure are provided in Chapter II, Section 2 of Annex XV of the MDR and in Annex B of ISO14155 (2020). Guidance on the content of the Investigator's Brochure can be found in MDCG 2024-5.
For files falling under MDR article 74.1, it is sufficient to submit an Instruction For Use (IFU).