Investigator's brochure (IB)

The IB gives investigators what they need to understand the device and its risks. It is kept up to date during the investigation, and the EU MDR lists its content in Annex XV.

compilation of the current clinical and non-clinical information on the investigational medical device(s) (3.29), relevant to the clinical investigation (3.8)

ISO 14155:2020, clause 3.31