‘Investigator's brochure’ means a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in humans. EU 536/2014 Art. 2 Abs. 2 (23)

Compilation of the current clinical and non-clinical information on the investigational medical device(s), relevant to the clinical investigation. ISO 14155:2020 (3.31)