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    Cardiovascular Surgery
    • Whitepaper
      Medical Devices

    Symbols and Information to be Provided with Medical Devices and IVDs

    The information supplied with the device is a fundamental requirement for the safe use of a medical/in vitro diagnostic device.

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    In this document:

    This paper offers guidance on the fundamental requirements for the safe use of a medical/in vitro diagnostic device.

    • Harmonized standards.

    • General safety and performance requirements (GSPR).

    • Use of symbols.

    • Label, IFU and implant card requirements.

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