The IB shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. The information shall be presented in a concise, simple, objective, balanced, and non-promotional form that enables a potential investigator and the investigation site team, to understand it and make his/her own unbiased benefit-risk analysis of the appropriateness of exposing study participants to the investigational device.
Further the IB should contain sufficient information to allow safe and correct use of the device.
Note that it is preferred for all necessary information to be included in the IB. However, if it is decided to move part of the information to annexes, then a clear reference should be made in the IB and the annexes enclosed with the application. The reference in the IB should clearly state the title of the referenced document and the section in which the information is given.
A summary of the referenced document should still be provided in the IB, as the IB should be possible to read as a stand-alone document.