The revised guidance emphasizes the importance of the Investigator’s Brochure (IB) as part of the required documentation, providing technical and clinical data about the device being investigated. Sponsors are encouraged to use a checklist provided in the guidance document to ensure completeness and compliance with Article 70 of the MDR. It also clarifies that the guidance applies specifically to IBs for clinical investigations under the MDR and not to performance study IBs under the IVDR.
MDCG changed the Investigator’s Brochure content -and issued MDCG 2024-5
What are the changes in the Investigator’s Brochure?
The document provides detailed guidance on creating an Investigator’s Brochure (IB) for clinical investigations of medical devices under EU Regulation 2017/745 (MDR) and aligns with ISO 14155:2020 – Clinical investigation of medical devices for human subjects – Good clinical practice.
- It offers sponsors a comprehensive overview of how to compile and present necessary information in the IB, ensuring the safety, functionality, and legal compliance of the investigational device.
- The content of the Investigator’s Brochure includes details on investigational device information such as device identification, intended purpose, clinical performance, and device classification. It also covers general device descriptions, including design, materials used, and technical specifications, as well as information on labels, instructions for use, and necessary training for device use.
- Pre-clinical evaluation details are provided, outlining recommendations and specific tests such as bench testing, reliability, and usability tests. Additionally, existing clinical data from earlier studies and other relevant investigations are included, along with risk management considerations, including anticipated serious adverse events and device effects.
- Special considerations are addressed for devices that incorporate medicinal substances or are made from human or animal tissues. Appendices provide additional reference materials and checklists to aid in the preparation of the IB.
- The guide emphasizes clarity, completeness, and non-promotional content in the IB to assist competent authorities in assessing the application for a clinical investigation, thus facilitating the review process.
See more:
