An investigator's brochure has to justify exposure

An investigator's brochure gets treated, on a lot of device trials, as a padded version of the marketing literature — a document that explains what the device does and how it works, handed to investigators mostly so they have something to read before the first visit. ISO 14155:2020 defines the document's job more narrowly than that, and more usefully: an investigator's brochure exists to give the principal investigator and the site team sufficient safety and performance data to justify human exposure to the investigational device in the first place. Explaining how the device works is a means to that end, not the end itself.

The standard's own definition sets the bar

ISO 14155:2020 defines the investigator's brochure, in the standard's own terms, as the document assembled to give the investigator and their team enough safety or performance data to justify the study's exposure of human subjects to the device. That framing puts the burden on the sponsor to make an affirmative case, not simply disclose what's known. An IB that lists test results without connecting them to a conclusion about acceptable risk has supplied data without doing the job the standard actually assigns the document.

Preclinical evidence has to cover the device's actual hazards, not a generic list

Annex B's content requirements run through the preclinical evidence a device of this kind would be expected to generate: design calculations, in vitro testing, mechanical and electrical safety testing where applicable, reliability testing, software validation, performance testing, ex vivo and in vivo animal testing, biological safety evaluation, and validation of any cleaning, disinfection, or sterilization process the device depends on. Not every device implicates every category — a single-use diagnostic strip has no sterilization-validation section to write — but the categories a device's own risk profile does implicate aren't optional to include because the study is small or the device is a modest iteration of one already marketed.

A brochure has to read as a case, not a compilation

The standard's own instruction is that the content be concise, simple, objective, balanced, and non-promotional — presented so a clinician evaluating the study, not a specialist who built the device, can follow the reasoning. A brochure that reproduces engineering test reports wholesale satisfies the letter of “data included” while failing the standard's actual ask, which is a document a site investigator can use to understand what they're exposing a subject to and why that exposure is justified. The same discipline runs through the clinical investigation plan this blog covers in a companion note: a CIP's own risk analysis is supposed to draw on the IB's conclusions rather than sit next to them unconnected, and a brochure written as raw data has nothing for that analysis to draw on.

The guidance layer sharpens what MDR expects on top

MDCG 2024-5, the Commission's 2024 guidance on IB content under the MDR, describes the sections in more operational detail than the standard's annex alone — down to how a sponsor should update the document as new preclinical or clinical data becomes available over a study's life, rather than treating the brochure as fixed once the investigation opens. An IB that hasn't been revisited since first-subject-in is a document the standard expects to have moved, going stale the same quiet way any other template does when nobody's watching its source.

An update to the brochure can reopen a duty back in the consent form

That update obligation doesn't stop at the brochure's own cover page. A new finding significant enough to change the IB's risk-benefit picture is also, in most cases, exactly the kind of significant new finding 21 CFR 50.25(b) requires be disclosed to subjects already enrolled — a duty this blog has traced through the consent form's own required elements. A sponsor that revises the brochure but treats the consent form as a document closed at enrollment has updated one half of a pair the regulation expects to move together.

Where this meets the file

An IB outline built around Annex B's own evidence categories, with a revision log that shows when new preclinical or clinical data last moved the document, is previewed in the launch catalog, alongside the clinical investigation plan and informed consent records that draw on it. If your program maintains this differently, the shelf takes that correction directly.