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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.

Watch the Webinar View the Presentation

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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