Guide
How to write an investigator's brochure
An investigator's brochure (IB) gives investigators the clinical and non-clinical information they need to run a study safely. For medical device clinical investigations, ISO 14155 Annex B describes its content, and EU MDR Annex XV lists it among the documents for a clinical investigation application.
What goes in
The core sections of a device IB
Device identification and description
Name, model, intended purpose, materials, principle of operation, and how the device is installed, used and maintained.
Pre-clinical evidence
Summaries of bench, biocompatibility, electrical safety, software and animal testing that support the investigation.
Existing clinical data
Relevant literature and prior clinical experience with the device or similar devices, including safety findings.
Risk management summary
Anticipated risks, residual risks and adverse device effects, with the risk-benefit reasoning behind the investigation.
Writing and maintaining it
A workable process
- 1Start from the ISO 14155 Annex B outline and the requirements of each country where the study will run.
- 2Pull content from controlled sources — design history, risk file, test reports — rather than rewriting it.
- 3Write for investigators: clear instructions for use and safety information come before background.
- 4Put the IB under version control with review and approval signatures before it goes to sites and ethics committees.
- 5Update it when significant new safety or performance information emerges, and track which version each site holds.
Where Qevatrix fits
Controlled study documents, delivered to sites
ClinicalOS keeps the IB, protocol and consent forms version-controlled with e-signatures, distributes the approved version to each site and records ethics approvals in a shared depository.
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This guide is an orientation, not regulatory advice. Confirm content requirements against the current ISO 14155, EU MDR Annex XV and the rules of each country and ethics committee involved.