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.

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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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