Investigator’s Brochure (IB) for Medical Devices
Introduction to Investigator’s Brochure (IB)
One critical document sponsors need to submit when preparing for a clinical investigation under the Medical Device Regulation (MDR) is the Investigator’s Brochure (IB). This guide will walk you through the IB's essential elements, ensuring you understand its importance and how to prepare it effectively.
Understanding the Investigator’s Brochure (IB)
The Investigator’s Brochure (IB) is a document that compiles all relevant clinical and non-clinical data on an investigational device. Providing investigators with the necessary information to conduct a clinical study safely and effectively is crucial. The IB helps ensure that the investigators can perform an unbiased benefit-risk analysis and understand the device's safety and functionality.
Key Components of the Investigator’s Brochure
1. Administrative Details
- Identification: The IB must be clearly identified with the name of the investigational device, a document reference number, version, and date. It should also include a confidentiality statement, revision history, and table of contents.
- Sponsor and Manufacturer Details: Provide the name and address of the sponsor and the manufacturer if different from the sponsor.
- Pagination: Each page should be numbered, indicating the total number of pages.
2. Investigational Device Information
- Device Identification: Clearly state the device's name, ensuring consistency throughout the documentation.
- Intended Purpose: Specify the intended purpose, including indications, contraindications, target patient groups, and intended users. Highlight any differences between the clinical investigation's intended purpose and the market-intended purpose.
- Clinical Performance: Describe the device's performance in clinical terms, including the mechanisms through which it achieves its intended purpose and the expected clinical benefits for patients.
- Qualification and Classification: Explain why the device qualifies as a medical device and state its risk class according to the MDR.
- Design and Manufacturing: Include detailed descriptions of the device's design, key functional elements, materials used, technical specifications, and relevant manufacturing processes.
- Previous Versions: Provide an overview of previous and similar generations of the device, focusing on clinical and pre-clinical testing stages.
- Equivalent Devices: Summarize equivalent or similar devices available in the market, focusing on their key features and intended purposes.
3. Labels and Instructions for Use
- Instructions for Use (IFU): Include the manufacturer’s instructions for installation, maintenance, use, storage, and handling requirements. If the device is CE-marked, provide both the standard and study-specific IFUs if it is used outside the CE-marked purpose.
- Labels: Ensure labels contain all necessary information, including the text "exclusively for clinical investigation" if applicable. Include graphic presentations of the labels.
- Training: Describe any training required for investigators.
- Implant Card: For implantable devices, provide a study implant card for patient safety.
4. Pre-Clinical Evaluation
- General Recommendations: Summarize relevant pre-clinical testing and experimental data, ensuring compliance with applicable standards and common specifications.
- Performance and Reliability Tests: Detail the tests conducted to evaluate the device's performance and reliability.
- Interoperability and Compatibility: Summarize evidence of the device’s interoperability and compatibility with other devices.
- Usability Tests: Describe usability tests, emphasising safety and performance.
- Mechanical and Electrical Safety: Provide details of mechanical, electrical safety, and electromagnetic compatibility tests.
- Biocompatibility: Summarize biocompatibility and biological safety evaluations.
- Software Verification and Validation: Describe the software design and validation process.
- Cybersecurity: Summarize cybersecurity tests performed to ensure the device's security.
- Cleaning, Disinfection, and Sterilization: Provide validation reports for sterilisation methods and summaries for cleaning and disinfection methods.
- Packaging Validation: Describe how packaging systems were validated to maintain the device’s integrity and sterility.
5. Existing Clinical Data
- Scientific Literature and Studies: Include relevant clinical data from scientific literature and previous investigations.
- Ongoing and Completed Investigations: Provide an overview of ongoing and completed clinical investigations with the investigational device.
- Compassionate Use: Describe any compassionate use of the device and relevant findings.
6. Risk Management
- Benefit-Risk Analysis: Summarize the benefit-risk analysis and risk management process, including known risks, side effects, contraindications, and warnings.
- Risk Control Measures: Describe measures taken to reduce identified risks, including design changes, protective measures, and communication of safety information.
- Anticipated SAEs and SADEs: Provide a table of anticipated serious adverse events (SAEs) and serious adverse device effects (SADEs) with their probabilities and references.
7. Devices Incorporating Medicinal Substances
- General Requirements: Include detailed information on any medicinal substances, human blood or plasma derivatives, or non-viable tissues or cells of human or animal origin incorporated into the device.
- Quality Aspects: Provide detailed quality information on the incorporated substances.
- Incorporation Process: Describe the process of incorporating the medicinal substance into the device and the methods used to verify its quality and release.
8. Procedures
- Clinical Procedures and Diagnostic Tests: Detail the clinical procedures and diagnostic tests used in the investigation, highlighting any deviations from normal clinical practice.
- Combination with Other Products: Specify any other devices or medicinal products used in combination with the investigational device and describe any potential new risks.
Preparing a Compliant IB
Review Regulatory Guidelines
Sponsors are encouraged to review the full details of the MDR and the ISO 14155:2020 standard when preparing the IB. These guidelines provide comprehensive requirements for clinical investigations and ensure the IB meets all regulatory standards.
Use Checklists
Utilise checklists, such as those provided in the guidance documents, to ensure the IB meets the minimum requirements for validation. Completing these checklists can help streamline the review process by competent authorities.
Keep Information Updated
Sponsors must update the IB with any new information and notify the member states concerned within one week of making any changes. Ensure that updates are clearly identifiable to facilitate the review process.
Conclusion
The Investigator’s Brochure is a crucial document for clinical investigations, providing investigators with comprehensive information about the investigational device. By following this guide and adhering to regulatory standards, sponsors can ensure that their IBs are thorough and compliant and facilitate a smooth review process by competent authorities.
Our experts at Med-Di-Dia are dedicated to helping you create a comprehensive Investigator's Brochure (IB) that meets all regulatory requirements and facilitates a smooth review process. Leveraging their extensive experience in the medical device industry, our specialists provide tailored support, ensuring your IB includes all necessary clinical and non-clinical data.
From detailing the device's intended purpose and performance to compiling risk management information, our team guides you through each step, making the complex task of IB preparation straightforward and efficient.
Let Med-Di-Dia's expertise ensure a robust and compliant IB backs your clinical investigation.
Reach out to our experts by sending an email to mdd@mddltd.com or by submitting a web form - https://med-di-dia.com/contact.php
