The investigator Brochure is a well known document needed to have the authorization to perform a clinical investigation study on a medical device, in order to evaluate its safety and performance within a clinical setting.
The investigator brochure is requested by different regulations and competent authorities that have the role to review documentation on the clinical study and the device involved in the clinical study before provide authorization to perform the specific study.
We have already been talking about the requirements related to clinical evaluation according to the European medical device regulation, and a specific Clinical Investigation Procedure aligned with EU MDR requirements has been made available in QualityMedDev Shop ready to be downloaded.
In this article we will go through the requirements associated to the investigator brochure according to the European Medical Device Regulation 2017/745 and European In Vitro Diagnostic Regulation 2017/746.
Investigator’s Brochure: Overall of the main Requirements
The requirements for the investigator brochure are defined in the Annex XV, Chapter II of the regulation. Specifically, the chapter II is defining the documentation needed to support the application to request authorization to perform clinical studies.
The regulation details the specific documents that need to be included in the investigator brochure, that will have to be submitted to the specific competent authority.
As explained in the introductive part of Chapter II, Section XV of the MDR:
The investigator’s brochure (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.
Moreover, it is important to mention that the changes to the investigator’s brochure need to be handled in a careful way and the investigator shall be informed in a timely manner of any changes or updates performed.
Specifically, these are the documents/items needed to be included in the investigator brochure.
First of all, information needed to clearly identify and describe the device have to be included. This may include the intended use statement and the classification of the device according to Annex VIII.
It is necessary to include the instructions to properly install, maintain and clean the device, if applicable. In this part, it is also necessary to include information to be placed on the label and the necessary instructions for use, including the necessity to perform training to the end user (patient, healthcare professional or any other involved person) on the use of the device.
This requirement is mainly related to all the information needed to be safely used the device, including information related to the labelling, IFU and related topics.
The next section of the investigator’s brochure is related to the results of pre-clinical tests performed on the device. These tests may include, as specifically mentioned in the regulation “design calculations, in vitro tests, ex-vivo tests, animal tests, mechanical or electrical tests, reliability tests, sterilization validation, software verification and validation, performance tests, evaluation of biocompatibility and biological safety, as applicable”.
It is also very important to include existing clinical data related to the device, for example literature data that may provide evidences on the safety, quality and efficacy of the device or of equivalent/similar device.
In this context, any other relevant clinical data gathered in a different method thank through literature search shall also be included in this section of the investigator’s brochure.
Risk management information needs to be included, including specific information on undesirable side effect, warnings and the summary of the benefit/risk analysis.
Furthermore, detailed information on the fulfilment of the relevant general safety and performance requirements as per Annex I of the Regulation need to be included. This may take in consideration all the harmonized standards and common specifications used to provide evidence of the conformity to the General Safety and Performance Requirements.
It is important to mention that we have been already discussing in separating articles about common specifications and how they can be used in order to proof compliance to specific general safety and performance requirements. In case specific standards or commons specifications have been only partially fulfilled, this needs to be clearly mentioned within the investigator’s brochure.
On a side note, we have also been discussing about the topic of General Safety and Performance Requirements, including a specific pre-filled in checklist that provides a full guidance on how it is possible to ensure compliance to the GSPR.
Specific requirements applied for the investigator’s brochure of medical device containing a medicinal substance or including human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives. We have been discussing about the ISO 22442-1 and the application of the risk management process for medical devices containing tissues or cells of animals or human derivatives.
Specifically, in the context of the investigator’s brochure, for these types of devices it is necessary to include:
- detailed information on the medicinal substance or on the tissues, cells or their derivatives included on the device;
- evidences of the compliance to the GSPR;
- risk management considerations in relation to the incorporation of the specific substances or cells/tissues on the device;
- evidence for the added value of incorporation of such constituents in relation to the clinical benefit and/or safety of the device.
Finally one last requirement is mentioned in the point 2.8 of Chapter II Annex XV of EU MDR 2017/745. Specifically, the investigator’s brochure needs to contain:
A detailed description of the clinical procedures and diagnostic tests used in the course of the clinical investigation and in particular information on any deviation from normal clinical practice.
Investigator Brochure Template
QualityMedDev has made available the Investigator Brochure Template, to further support the preparation of documentation related for clinical trial operations. This is an essential template that will definitely speed up the preparation of regulatory documentation and accelerate the time to bring the device on the market.
Conclusions
It is important to mention that this article did not take in consideration all the requirements associated to the clinical investigation process according to the EU MDR. Instead, this article focused specifically only on the contents of the investigator’s brochure, a mandatory dossier to be submitted to the specific competent authority in order to obtain the authorization to perform a clinical study on a medical device, in order to gather data on safety and performance of the device.
We have been discussing about the contents of the investigator’s brochure, the main requirements associated to this specific file in relation to the EU MDR.
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