Recently the MDCG (Medical Device Coordination Group) published a guidance on the content of the Investigator’s Brochure for clinical investigations of medical devices (MDCG 2024-5).
According to article 70 (1) of the Regulation (EU) 2017/ 745 (MDR) when a sponsor of a clinical investigation submits an application, he shall accompany it by the documentation referred to in Chapter II of Annex XV of the MDR. Part of this documentation is the Investigator’s Brochure (IB).
The MDCG 2024-5 guidance provides clarification on what a complete IB should include. More specifically, it indicates that an IB should comprise:
- Information of the investigational device: Identification and description of the device, including information on the intended purpose, the risk classification and applicable classification rule of the regulation, intended clinical performance, design and manufacturing of the device, and reference to previous and similar generations of the device.
- Labels and instructions for use: The IB should entail manufacturer’s labels and instructions for installation, maintenance, maintaining of hygienic standards and use of the investigational device, including any necessary storage and handling requirements. For implantable devices, also study implant card is recommended to be part of the IB.
- Pre-clinical evaluation: A pre-clinical evaluation based on relevant pre-clinical testing and experimental data, in particular in-design calculations, in vitro tests, ex vivo tests, animal tests, and “Vertical” tests (depending on the device type).
- Existing clinical data: The IB should include existing clinical data, in particular:
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- from relevant scientific literature available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of the device and/or of equivalent or similar devices.
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- other relevant clinical data available relating to the safety, performance, clinical benefits to patients, design characteristics and intended purpose of equivalent or similar devices of the same manufacturer, including length of time on the market and a review of performance, clinical benefit and safety-related issues and any corrective actions taken.
- Risk management of the investigational device: A summary of the benefit-risk analysis and the risk management, including information regarding known or foreseeable risks, any undesirable side-effects, contraindications, and warnings.
- Fulfilment of General Safety and Performance Requirements List.
- Procedures that will be followed: A detailed description of the clinical procedures and diagnostic tests used during the clinical investigation and in particular information on any deviation from normal clinical practice.
The guidance makes special mention to the IB and related requirements of medical devices that incorporate a medicinal substance, including human blood or plasma derivative or, devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives.
In addition, the new MDCG guidance includes a proposed checklist – in its Appendix A – for the sponsors to complete, prior to submission, to ensure that the IB meets the minimum requirements for validation of the application per article 70 of the MDR.
Check the whole guidance on content of the Investigator’s Brochure for MDR clinical investigations in our dedicated Library of Documents or contact us for any questions!
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