Europe – MDCG 2024-5 guidance 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. For the purpose of this guidance document, medical devices, accessories for medical devices, and products listed in Annex XVI shall hereinafter be referred to as ‘devices’.