Introduction
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’.
Section 2 of Chapter II of Annex XV of the MDR describes the required content of the IB. Please note that by submitting complete applications and documents that contain all the required content, this helps competent authorities in assessing the application, which facilitates the review process. Prior to submission of the IB, sponsor is recommended to complete the checklist in Appendix A of this guidance, to ensure the IB meets the minimum requirements for validation of the application per article 70 of the MDR. The checklist, if used, should be included together with the IB in the submission.
When preparing the IB, sponsors are encouraged to review the full details of the regulation as well as the normative Annex B of the international standard ISO14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice.
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.
Note that any updates to the IB or other relevant information that is newly available shall be brought to the attention of the investigators in a timely manner. Further, when the IB is updated, the sponsor needs to notify the member states concerned within one week. Changes made to the IB shall be clearly identifiable.
Note that the scope of this guidance is IBs written for clinical investigations as defined by the MDR, and it is not intended to be applied for performance study IBs under the IVDR.
MDCG 2024-5 - Guidance on the Investigator’s Brochure content - April 2024
MDCG 2024-5 - Guidance on the Investigator’s Brochure content - April 2024
health.ec.europa.eu
