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      Medical Devices

    IVDR Amending Regulation (EU) 2024/1860 FAQs

    Guidance incorporating IVD manufacturer feedback on Amending Regulation 2024/1860 and IVDR transitional provisions implementation.

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    Guidance on IVDR transitional provisions

    Download the Q&A to find out more about:

    • IVDR transition cases & Article 110.

    • Confirmation letters.

    • QMS documentation requirements.

    • Appropriate Surveillance of legacy devices.

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    Innovative solutions for Sterile Medical Devices

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    Cardiovascular Surgery
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    Symbols & Details Required for Medical Devices & IVDs

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    PFAS phase out and their impact on Medical Devices

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