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    • Webinar
      Medical Devices

    Understanding and meeting the EU IVDR requirements for IVD Kits

    This webinar will be relevant for IVD manufacturers, distributors and importers.

    Key takeaways and learning objectives

    • Definitions of IVD Kits, accessories, components and procedure packs

    • Qualification and classification of IVD kits, components and accessories

    • Regulatory requirements for IVD kits, components and accessories

    • Product configurations and potential certification scenarios

    • Market placement of IVD kits, components and accessories

    Speakers

    Presenter information

    Alex Laan - Head of Notified Body, IVD

    Sara Fabi - Regulatory Lead, Notified Body, IVD

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