What is the webinar about?

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

This webinar, delivered by regulatory experts from BSI, will provide an update on the latest IVDR developments, with a specific focus on what Class C IVD manufacturers must look out for and prioritize to remain compliant.

The session will cover:

  • IVDR 2026 regulatory milestones and how transition timelines impact Class C self-declared IVDs 
  • Key conformity assessment requirements for Class C devices, including 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 of May and September 2026 deadlines
  • Next steps manufacturers should take now to avoid disruption to market access

Who should attend?

Designed for regulatory, quality, and product leaders, this webinar will help organizations, like yours, to better understand the implications of the upcoming IVDR transition deadlines, assess their current state of readiness, and plan effectively for an efficient transition before critical deadlines take effect.

Speakers

 
Alex
Laan
Head of IVD Notified Body, BSI
Speaker – AM & PM sessions
 
Charlotte
Hess
IVD Business Development Manager - EU, BSI
Speaker – AM session
 
Nathalie
Beaudoin
IVD Business Development Manager – US, BSI
Speaker – PM session
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