MDCG Guidance on Investigator’s Brochure (IB) for Medical Device Clinical Investigations

The Investigator’s Brochure (IB) is a critical document required for medical device clinical investigations under the EU Medical Device Regulation (MDR). This document provides essential technical and clinical information about the investigational device, ensuring that investigators have the necessary details to conduct the investigation safely and effectively. The Medical Device Coordination Group (MDCG) offers guidance on what to include in the IB, ensuring that manufacturers submit complete and compliant documentation for regulatory approval. 

In this article, we will walk you through the key aspects of the Investigator’s Brochure and how BioBoston Consulting can assist in developing this essential document for your clinical investigation. 

What is the Investigator’s Brochure (IB)? 

The Investigator’s Brochure (IB) serves as an essential tool for manufacturers and investigators in medical device clinical trials. It provides a comprehensive summary of all relevant data on the device, including its design, intended purpose, preclinical testing, and clinical performance, as well as any potential risks. The purpose of the IB is to ensure that the investigator has all necessary information to evaluate the safety and efficacy of the device during the clinical investigation process. 

Under the EU MDR, the IB must meet specific regulatory requirements outlined by both the MDR and ISO 14155:2020 standards. This guidance document, issued by the MDCG, helps manufacturers navigate the complexities of preparing a compliant IB for submission to competent authorities. 

Key Information to Include in the Investigator’s Brochure 

The MDCG provides detailed guidance on what information should be included in the Investigator’s Brochure. Here is an overview of the essential sections: 

Administrative Details 

The IB must be clearly identified and include the following administrative details: 

• Device identification: Name, reference number, and version of the investigational device. 

• Sponsor and manufacturer contact details: Essential for communication. 

• Confidentiality statement: To ensure protection of intellectual property. 

• Revision history: A summary of changes made to the IB. 

• Table of contents: A comprehensive list for easy reference. 

These administrative details provide the foundation for organizing the IB, ensuring clarity and consistency. 

Investigational Device Information 

This section focuses on the essential technical and clinical data related to the device: 

• Identification of the device: Including its intended purpose and clinical performance. 

• Qualification and classification: Description of the device’s risk classification and the rationale for its classification. 

• Design and manufacturing: Overview of the design, manufacturing processes, and any similar devices. 

• References to similar generations: Providing context through comparisons with previous versions or similar devices. 

This information is crucial to give the clinical investigators a thorough understanding of the device’s specifications, risks, and benefits. 

Labels and Instructions for Use (IFU) 

The IB should also include information on device labeling and instructions for use (IFU): 

• Instructions for Installation and Use: These must be included for both CE-marked and non-CE-marked devices. 

• Labels: Information that will appear on the device label, including warnings such as “exclusively for clinical investigation.” 

• Training Requirements: Any training needs for those involved in the clinical investigation. 

• Implant Card: For implantable devices, a study-specific implant card for patient safety should be provided. 

Providing clear and detailed instructions helps ensure that devices are used correctly and safely during the investigation. 

Preclinical Evaluation 

Preclinical testing is a vital part of the IB. It should include: 

• In vitro, ex vivo, and animal testing: Results from laboratory and animal studies. 

• Biocompatibility and software validation: Ensuring that the device is safe for use in humans and performs as intended. 

These results form the foundation for assessing the safety of the device prior to human trials. 

Existing Clinical Data 

The IB should incorporate any existing clinical data from previous investigations or scientific literature. This data should cover: 

• Safety and performance: Results from similar devices or previous studies. 

• Clinical benefits: Evidence demonstrating the positive impact on patient outcomes. 

Existing clinical data can help regulators assess the potential risks and benefits of the device, building confidence in its safety profile. 

Risk Management of the Investigational Device 

Risk management is a critical element of the IB. It should summarize the benefit-risk analysis and detail known and foreseeable risks, including: 

• Side effects, contraindications, and warnings: Identifying potential risks based on preclinical and clinical data. 

• Risk management process: Describing the steps taken to evaluate and control risks. 

This section ensures that potential hazards are identified and that appropriate mitigation strategies are in place to protect patient safety. 

Anticipated Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) 

An essential component of the IB is the assessment of anticipated SAEs and SADEs. Based on internal risk management documents, manufacturers should provide a tabular summary of the expected frequency and types of adverse events associated with the device. This assessment is crucial for understanding the clinical investigation’s risk-benefit ratio. 

Why a Well-Prepared Investigator’s Brochure is Essential 

A well-prepared Investigator’s Brochure (IB) ensures smooth regulatory submissions and successful clinical investigations. By clearly presenting device information, preclinical data, risk assessments, and instructions for use, manufacturers can support the investigators in making informed decisions about patient safety and device efficacy. The MDCG’s guidance emphasizes the importance of clarity, completeness, and transparency when drafting the IB to meet regulatory expectations and avoid delays in the approval process. 

BioBoston Consulting: Your Partner in Clinical Investigation Documentation 

Navigating the regulatory requirements of the EU MDR and preparing a compliant Investigator’s Brochure can be complex. BioBoston Consulting is here to help you streamline the process and ensure that your clinical investigation documentation meets all necessary standards. We specialize in assisting manufacturers with: 

• Investigator’s Brochure (IB) preparation: Crafting a well-organized and thorough IB that meets MDR and ISO 14155:2020 requirements. 

• Preclinical and clinical data analysis: Ensuring that all necessary test results and previous study data are included and properly evaluated. 

• Risk management support: Assisting with the identification, evaluation, and control of risks in your clinical investigation. 

If you are ready to ensure that your Investigator’s Brochure complies with EU MDR requirements, reach out to BioBoston Consulting for expert assistance in navigating the regulatory landscape and advancing your clinical investigations. 

Contact BioBoston Consulting today to streamline your clinical investigation documentation and ensure full MDR compliance!