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In vitro diagnostic medical devices (EU) 2017/746 definitions that reflect changes in technology, progress in diagnostics and regulatory oversight.
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.
Head of IVD Notified Body, BSI.
Regulatory Lead, IVDR, BSI.
Reach out and see how we can help guide you on your path to sustainable operational success.