MDCG 2024-5 Guidance document on content of the Investigator’s Brochure for clinical investigations of medical devices

When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR. The Investigator’s Brochure (IB) is part of the required documentation and is one of the means by which the sponsor is to fulfil the requirement in section 2.7 of Chapter I of Annex XV of the MDR which states that the investigator shall have access to technical and clinical data regarding the device that is being investigated. This includes the intended purpose(s), design, the basic fundamental scientific principles behind the design and the level of objective evidence already in place, to assure its safety and functionality during the investigation.

This guidance document is intended to support sponsors in developing their IB by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application. The guidance is based on the requirements of both the MDR and ISO14155:2020 as well as experience from the competent authorities.

In the absence of a dedicated guidance document for the IB that is also required as per Annex XIV of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) for interventional clinical performance studies and certain other performance studies, this guidance can be used as reference what is to be expected for these studies.