New MDCG Guidance on Investigator’s Brochure for Medical Device Trials

The Medical Device Coordination Group (MDCG) is active this month, releasing a new guidance document. This latest guidance focuses on the preparation of the Investigator’s Brochure (IB) for clinical investigations of medical devices. 

The newly issued guidance document, MDCG 2024-5, provides detailed instructions for sponsors on how to prepare an Investigator’s Brochure (IB). The IB is a crucial document that outlines specific information about the medical device under investigation. 

Key Highlights: 

• • • Content Requirements: The guidance outlines the specific content that should be included in the IB. This includes the identification and description of the device, its intended purpose, risk classification, design, and manufacturing details. 
    • Objective Presentation: Emphasizing the importance of an unbiased benefit-risk analysis, the document stresses that the IB should be presented in a concise, objective, balanced, and non-promotional form. 
    • Checklist for Validation: To assist sponsors in ensuring compliance, a checklist is included to verify that the IB meets the minimum requirements for validation of the application as per Article 70 of the Medical Device Regulation (MDR). 

This new guidance document is a valuable resource for sponsors involved in clinical investigations of medical devices, providing clear and comprehensive instructions for the preparation of the Investigator’s Brochure. 

Stay tuned for more updates from the MDCG, as they continue to provide valuable guidance and support for the medical device industry. 

For more information, you can find the full MDCG guidance document here.