IVDR Webinar Series 2026: Where To Start

The transition to the In Vitro Diagnostic Medical Devices Regulation (IVDR) has fundamentally changed the regulatory landscape for IVD manufacturers.

Where to Start with Your First Notified Body Application

Led by our Notified Body specialists, IVD technical experts and commercial team, each webinar shares practical guidance for manufacturers.

Direct access to regulatory specialists and technical experts with deep industry knowledge.
Ask the questions that matter in open discussions and live Q&A sessions.
Avoid common pitfalls by understanding key requirements and assessment deficiencies early.
Built for the long term: prepare for ongoing compliance throughout the product lifecycle.

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

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.
Engaging a Notified Body under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for the first time raises a lot of questions. This session explains the conformity assessment process step by step and the role of the Notified Body in your IVDR conformity assessment, giving you a greater understanding of where to start with your IVDR certification journey.

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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.

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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.