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    Equipment in operating theatre
    • Webinar
      Medical Devices

    What Class C IVD Device Manufacturers Must Do Now to Meet Upcoming Deadlines

    With Class C self-declared IVDR transition deadlines approaching, manufacturers face compliance requirements that call for immediate attention.

    Watch webinar on-demand View the Presentation

    Understand the implications of the upcoming IVDR transition deadlines

    Specifically focusing on what Class C IVD manufacturers must look out for and prioritize to remain compliant.

    • IVDR 2026 regulatory milestones and how transition timelines impact Class C self-declared IVDs .

    • Key conformity assessment requirements for Class C devices.

    • Clinical evidence, performance evaluation, and technical documentation expectations.

    • Common readiness gaps and risks observed in Class C devices applications and how to mitigate them.

    • Notified Body capacity, review timelines, and planning considerations ahead 2026 deadlines.

    • Next steps manufacturers should take now to avoid disruption to market access.

    Speakers

    Hear from the experts in this webinar

    Speaker

    Alex Laan

    Head of IVD Notified Body, BSI
    Speaker

    Charlotte Hess

    IVD Business Development Manager - EU, BSI

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    Learn from global experts in healthcare standards

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