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    • Webinar
      Medical Devices

    Understanding and meeting the EU IVDR requirements for IVD Kits

    In vitro diagnostic medical devices (EU) 2017/746 definitions that reflect changes in technology, progress in diagnostics and regulatory oversight.

    Watch the Webinar View the Presentation

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

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

    • Market placement of IVD kits, components and accessories.

    • Qualification and classification of IVD kits, components and accessories.

    • Regulatory requirements for IVD kits, components and accessories.

    • Product configurations and potential certification scenarios.

    Speakers

    Hear from these experts in this webinar

    Speaker

    Alex Laan

    Head of IVD Notified Body, BSI.
    Speaker

    Sara Fabi

    Regulatory Lead, IVDR, BSI.

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