Investigator’s brochures for medical device clinical trials

All trials that investigate medical devices, regardless of device classification, should have an Investigator’s Brochure (IB), or equivalent documentation.

The IB compiles all available clinical and non-clinical data to inform on the safety of the investigational device that is to be studied in humans.

What to include

A brochure should inform the reader and help them make an unbiased benefit-risk assessment of the proposed trial.

Information in the brochure should be:

• written in English (other languages not accepted)
• in language the reader understands
• up to date
• presented in a concise, simple and non-promotional way.

A medically qualified person is expected to participate in the editing of your IB.

Recommended structure

We recommend that you present the information under the following headings: 

• General
  • Identification of the IB
  • Sponsor of the trial/manufacturer
• Investigational device information
• Preclinical testing
• Existing clinical data
• Risk management
• Regulatory and other references.

Ensuring completeness of your IB

You should pay particular attention to the following:

• Adequate characterisation/description of the device and its operation, for example:
  • Design/engineering drawing and electronic models of device, if available
  • Rationale for device design
  • Device and performance specifications
  • Description of materials (including biocompatibility information)
  • Description of function - how does the device and/or its components/subsystems work together to achieve the desired function
  • Verifications and validations reports for device, subsystems and main system
  • Usability studies, where applicable
• Adequate description of the manufacturing controls used to ensure that the devices are produced consistently and as designed (for example, compliance with ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes). 
• Include data-driven laboratory studies with detailed descriptions of methods and conclusions.
• Animal studies with validation of animal selection, scientific justification for the number of animals selected, and appropriate follow-up duration.
• A summary of prior publications, including copies of relevant publications (positive and negative) and relevant information.

More information