The First Step: Navigating Your IVDR Conformity Assessment

This session explains the conformity assessment process step by step and the role of the Notified Body in your IVDR conformity assessment.

Introduction to IVDR

Demystify the conformity process, what manufacturers should expect and prepare for successful engagement throughout.

Speakers

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Head of IVD Notified Body, BSI

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Associate Global IVD Head, BSI

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Western Sales Manager – EMEA, BSI

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Commercial Operations Director, Regulatory Services Americas, BSI - PM Session

Connect directly with our experts and build your understanding of key regulatory requirements and the conformity journey.

Learn what Notified Bodies expect from IVDR technical documentation during an assessment; including how to align clinical evidence and quality management processes, and how to strengthen your documentation to avoid delays in your conformity assessment.

22 October 2026 - 09:00 BST or 16:00 BST

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Understand your ongoing obligations after IVDR certification: post-market surveillance, performance follow-up, and managing the changes that require Notified Body involvement.

10 November 2026 - 09:00 GMT or 16:00 GMT

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Why Join This Series

Talk with our regulatory specialists and dedicated technical experts, who bring deep scientific knowledge of the industry.

An open fireside discussion and live Q&A in every session. Submit your questions when you register.

Understand regulatory requirements and the deficiencies most often raised during assessment, before they cost you time.

Certification is just the beginning. Prepare for ongoing compliance across the full product lifecycle.

Who Should Attend

Regulatory Affairs Managers And Specialists.

Regulatory Affairs Directors.

Quality And Regulatory Professionals.

SME Leadership, Including Managing Directors.