The MDCG has released a guidance document concerning the content of the investigator’s brochure for clinical investigations of medical devices. For some background, when a sponsor of a clinical investigation submits an application in accordance with article 70(1) of the MDR, the application shall be accompanied by the documentation referred to in Annex XV, Chapter II of the MDR. One of the required documentations that is required is the investigator’s brochure. The guidance document goes into detail on the expected contents of the investigator’s brochure including the following:
- Investigational Device Information
- Labels and Instructions for Use
- Pre-Clinical Evaluation
- Existing Clinical Data
- Risk Management of Investigational Devices
- Devices that incorporate a medicinal substance, including a human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives.
- Fulfilment of General Safety and Performance Requirements
- Procedures
The guidance document can be accessed using the following link
