Guidance for Investigator’s Brochure (IB) – Medical Devices
20 Nov 2024
Medical devices and their manufacturers are always bound by different regulations wherever they are manufactured globally. These regulations vary from country to country and region to region, which also matches their requirements. In this blog, we will provide guidance on one such requirement, i.e. the Investigator’s Brochure (IB). IB is a document required under Article 70(1) of EU MDR 2017/745. These requirements are primarily present in the Medical Device Coordination Group (MDCG) document, 2024-25.
What is Investigator’s Brochure?
IB, or Investigator’s Brochure, is an important document that medical device manufacturers must submit when they apply for clinical investigation. This document allows investigators to access clinical and technical data about a medical device (before and after the study).
Contents of the Investigator’s Brochure
The IB shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. The information shall be presented in a concise, simple, objective, balanced, and non-promotional form that enables a potential investigator and the investigation site team, to understand it and make his/her own unbiased benefit-risk analysis of the appropriateness of exposing study participants to the investigational device. Further, the IB should contain sufficient information to allow safe and correct use of the device. A summary of the referenced document should be provided in the IB, as the IB should be possible to read as a stand-alone document.
What Details are Added in the Investigator’s Brochure?
An Investigator’s Brochure contains the following important details:
- Administrative information
- Investigational device information
- Labels and Instructions for Use
- Pre-clinical Evaluation
- Existing clinical data
- Risk management of the investigational device
- Devices containing biological products or medicinal substances
- Compliance with General Safety and Performance Requirements (GSPR)
- Procedures
We will explain all the aforementioned contents of Investigator’s Brochure one-by-one below:
Administrative Information
An IB should contain all the important administrative details concerning the device, such as:
- The investigational device’s name
- Reference number of the document
- Version, and
- Date
Administrative information should also include details about the device’s manufacturer and sponsor, a table of contents, a confidentiality statement, and a summary of revisions.
Investigational Device Information
This section will include the following information about the device:
- Device identification: If multiple names have been used for the same device, this should be explained in the IB. It should also be ensured that the document mentions only consistent technology.
- The intended purpose of the device: The intended purpose will be mentioned clearly. It will mention any specific indications and contraindications of the device. Moreover, the following will also be included in this section.
- Intended users
- Target patient groups
- Any differences between the intended purpose of the clinical investigation
- Intended clinical performance of the device: This section describes the clinical performance the device should achieve. It will explain the technical and functional characteristics of the device that will benefit its users clinically. However, if a product has no intended medical purpose, then its performance demonstration must be included in the IB.
- Qualification and classification: This section contains a rationale explaining why the device qualifies as a medical device. The device’s risk class aligned with MDR definitions and classifications will also be included in this section. If a product is borderline, the manufacturer needs to add the scientific rationale to prove the device’s qualification.
- Literature and evaluation supporting the device’s design and its intended use: This section summarizes any previous researches, evaluations, and literature that supports device’s design and its intended use.
- General description of the device: IB must also describe the entailing design of the device, which will include important functional elements of the device, materials used in its manufacturing, and technical specifications. Photographs, drawings, and diagrams, along with their written explanation) will also be added in this section.
- Summary of any relevant manufacturing process: This section will summarize quality controls and manufacturing processes involved in the device’s production.
- References to any previous and similar versions of the device: This section summarizes the device’s previous and similar versions. However, the primary focus is on clinical use and late-stage development of these versions.
- Overview of any equivalent or similar versions of the device: The device sponsor should summarize any equivalent or similar devices available in the market. This will help determine the novelness of the device currently under investigation.
Labels and Instructions for Use
IB will also include instructions for maintenance, installation, device use, and storage and handling requirements. This section will also include any information meant to be placed on the label and instructions for use.
Here, the following considerations must be remembered:
- Instructions for Use (IFU): Any CE-marked device will include detailed instructions for use. If a CE-marked device is used outside the scope of its intended purpose, then study-specific IFU and CE-marked IFU must be included.
- Labels: Labels must contain information necessary for market placement. They will also contain information regarding investigational devices meant “only for clinical investigation.”
- Training: This section will describe any training needs and plans to conduct that training
- Implant card: For patient safety, implantable devices will be provided with an implant card. This card will include details according to MDCG and MDR guidance.
Pre-Clinical Evaluation
This section of the IB, pre-clinical evaluation, will contain any experimental data and clinical testing performed on (or for) the device. These tests include in-vitro and ex-vitro tests, mechanical and electrical tests, in-design calculations, biocompatibility evaluation, and software verification.
- General recommendations for pre-clinical evaluation will require their completion before clinical investigation application. If any situation arises where some of the pre-clinical testing has not been completed before the clinical investigation, the manufacturer must mention this clearly with proper justification. A summary of pre-clinical testing and evaluations should also be included in the summary.
- Specific recommendations regarding pre-clinical evaluation include reliability, compatibility tests, interoperability, detail performance, and any device-specific tests, such as software verification, cybersecurity, and mechanical and electrical safety.
Existing Clinical Data
IB should also include existing clinical data on the device from previous investigations and existing literature. Any data on similar and equivalent devices, as well as summaries of any completed and ongoing investigations, will also be included.
Risk Management of the Investigational Device
This section summarizes risk management and risk-benefit analysis, side effects, contraindications, foreseeable risks, and warnings associated with device use. The description of the risk management process will include risk analysis, its evaluation, and risk control measures.
Devices Containing Biological Materials or Medicinal Substances
Devices that contain human blood or plasma derivatives, non-viable cells or tissues of human or animal origin, or medicinal substances should provide detailed information on safety, quality, and compliance (along with their relevant requirements).
Information on quality aspects: Sponsors must provide detailed information on the device’s quality aspects. The competent authority will use this information to assess the device, which will, in turn, include specifications, stability data, and manufacturing processes.
Information about incorporation of medicinal substances: The IB should also include information required for evaluating the medicinal substance after it has been incorporated into the device. Further information will also be included, mentioning details of the incorporation process, purpose and quality of the excipients, and composition of the ultimate device.
Compliance with General Safety and Performance Requirements (GSPR)
The IB must also mention how the investigational device conforms to the relevant GSPR present in Annex I of EU MDR.
Procedures
IB should also describe about the diagnostic tests and clinical procedures used for clinical investigation. It should also identify any deviations the device may have from the normal clinical practices.
Fulfilling all these requirements regarding the Investigator’s Brochure can be cumbersome, but at TSQ&E, we have compliance professionals and consultants who are fully knowledgeable of EU MDR and its subsequent requirements. By contacting, you can book a session with our consultants, who can guide you through the entire process.
