The Medical Device Coordination Group (MDCG) has just released new guidance (MDCG 2024-5) to help streamline clinical investigations of medical devices.

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This new guidance focuses on the Investigator’s Brochure (IB), which is an essential document to give investigators access to important technical and clinical data about the device being studied. The new guidance provides clear instructions on what information should be included in different sections of the IB, making it easier for sponsors to meet regulatory requirements and avoid delays in the approval process.

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The MDCG has also provided a template for the Summary of Safety and Performance (SSP) (MDCG 2022-9 / Rev.1), required for in vitro diagnostic medical devices under EU regulations. The template is a useful tool for manufacturers to create SSP documents that meet regulatory standards.

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These updates from the MDCG aim to simplify regulatory processes, benefiting patients and fostering innovation in the development of medical devices.

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