Overview

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

Key takeaways and learning objectives

Join the webinar to learn about:

• 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

Presenter information

Speaker - Alex Laan - Head of Notified Body, IVD

Speaker - Sara Fabi - Regulatory Lead, Notified Body, IVD