QbD Group
    White Paper

    Clinical investigations under MDR: key insights and practical experiences

    This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

    December 10, 2024

    About this white paper

    Key topics covered in this resource

    • the ongoing harmonization in the authorization process by regulatory authorities and ethics committees,
    • the evolving role of the EU Legal Representative for sponsors outside Europe,
    • the influence of MDR on study conduct, with stricter requirements for safety reporting and post-market surveillance and future developments, including the integration of EUDAMED and the coordinated assessment procedure
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