Investigator’s Brochures for Medical Devices: key elements

Investigator's Brochures

Right in April 2024, the European Commission’s Medical Device Coordination Group (#MDCG) published their latest guidance, illustrating all things concerning the Investigator’s Brochure (IB) needed for clinical investigations of medical devices.

What is an Investigator Brochure?

The IB is a comprehensive document compiled by the sponsor of a clinical trial that provides detailed information about the investigational product being studied. It serves as a reference guide for investigators involved in the trial and contains critical information such as potential risks and side effects, and instructions for use in the trial. The IB aims to ensure that investigators have all necessary information to conduct the trial safely and effectively while adhering to regulatory requirements.

The information should be conveyed in a clear, straightforward, and objective manner, devoid of promotional language, ensuring that potential investigators and the investigation site team can readily comprehend it.

Which guidelines regulate IBs?

The required contents of IBs are described in Section 2 of Chapter II of Annex XV of the MDR. To further aid compliance with regulatory standards, the latest guidance includes a checklist (Appendix A) to ensure that IBs fulfill the minimum requirements for validation of the application as per Article 70 of the MDR. If this supplementary tool is utilized, it should be included in the submission package.

Moreover, IBs requirements are also present in ISO14155:2020.

Information included in IBs:

  • MD information: punctual identification of the device, including name, intended purpose, instructions for use, contra-indications, patient target group(s), the intended users, key functional elements, technical specifications and its classification according to MDR, including a rationale for MD qualification. The rationale should also include a summary of supporting literature! Additionally, a clear summary of utilized materials should be present, in table form.
  • Intended clinical performance: a description on how (the mechanisms through which) the device is able to achieve its intended purpose as claimed by the manufacturer.
  • Summary of manufacturing process, including design and quality controls.
  • Overview of similar and/or equivalent devices on the market.
  • Conformity to general safety and performance requirements (GSPR).
  • Summary of biocompatibility and biological safety on the device (BER).
  • In vivo testing conducted on the device in question and existing clinical data.
  • Summary of the benefit-risk analysis and the risk management.

 

Slightly different requirements apply to Investigator’s Brochures for Medical Devices that contain a medicinal substance. For example, their IB should also include information on tissues, cells or their derivatives used for their manufacturing.

As illustrated above, writing IBs can be quite complicated, as it requires knowledge and understanding of both the device under investigation and the regulatory framework around it. That’s why it is essential to rely on knowledgeable individuals when preparing a IB, as to ensure that the study participants are safe and that the documentation meets regulatory standards.


At ToxHub, our experts are well equipped to provide your company with state-of-the-art IBs. Additionally, we offer comprehensive support for Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP), ensuring regulatory compliance and efficacy in all aspects of your project. Do not hesitate to contact us for any of your needs.

 

Article issued by Chiara Gazerro