What is an investigator’s brochure?
The investigator’s brochure (IB) is referenced in the European Medical Devices Regulation (2017/745, MDR). However, those unfamiliar with the term IB will find it defined in Annex XV, Chapter II, Section 2. In the interest of completeness, there is a catch-all expectation in MDR Article 62 on clinical investigations. MDR Article 62(4)(m) states “the requirements of Annex XV are fulfilled.”
The IB is intended to include both non-clinical and clinical data on the investigational device. It is to be updated promptly. In addition, the information delineated in Annex XV, Chapter II, Section 2, 2.1-2.8 is expected to be included in the IB.
Background on ISO 14155
ISO 14155 as the standard on Clinical investigation of medical devices for human subjects - Good clinical practice defines IB (Clause 3, 3.1). The intent, of course, is almost identical to Annex XV, Chapter II, Section 2. The content of the ISO standard Clause 6, Section 6.5 adds more context as to the purpose. The IB should “provide the principal investigator and the investigation site team with sufficient safety or performance data … to justify human exposure to the investigational device…” There is additional instruction directed to the principal investigator.
Annex B of the standard provides extensive information about the IB.
EU Update: New Guidance on Clinical Investigation Investigators Brochures | Emergo by UL
EU Update: New Guidance on Clinical Investigation Investigators Brochures
Medical device makers doing business in the EU should become familiar with the regulatory requirement of providing an investigator’s brochure (IB).
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