The regulatory changes in IVDR and its implications for IVD manufacturers

In this recorded webinar, Dr. Oliver Eikenberg and Eva Camatini of IMQ deliver a detailed overview of the European In Vitro Diagnostic Regulation (IVDR) and the increasingly urgent steps manufacturers must take to maintain EU market access. As the transition from the In Vitro Diagnostic Directive (IVDD) to IVDR continues, IVD companies face greater complexity, tighter scrutiny, and stricter expectations around technical documentation, clinical evidence, and product lifecycle management.

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Designed for regulatory professionals, quality managers, and IVD manufacturers at all stages of compliance readiness, this session cuts through the confusion to highlight what matters most. Dr. Eikenberg explores the core regulatory shifts under IVDR, the implications for design and documentation, and the concrete steps manufacturers must take before critical deadlines in 2025, 2026, and 2027. His practical advice underscores the need for precision, consistency, and early engagement with Notified Bodies, especially for high-risk (Class D and C) devices.

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Key segments of the webinar include:

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• IVDR and Its Challenges
  An overview of the increased complexity of IVDR compared to IVDD, including expanded scope, heightened Notified Body oversight, and lifecycle-based compliance.
• Common Misunderstandings in IVD Regulations
  Clarifies frequent misinterpretations about manufacturer and regulator roles, QMS adaptation, and what Notified Bodies are actually allowed to do.
• The Critical Importance of Defining Intended Purpose in IVDs
  Why intended purpose must be precise, justified, and aligned across all documentation, and how it directly drives classification and conformity assessment.
• Understanding Clinical Evidence Requirements Under IVDR
  Breaks down performance evaluation obligations, the risk-based approach to evidence, and how to justify retrospective or non-EU data.
• Timelines for IVD Manufacturers: Why and What Matters Now?
  Reviews key deadlines for QMS updates, application lodging, and agreements with Notified Bodies, especially for legacy devices.
• Balancing IVD Legacy Device Data Gaps with New IVDR Requirements
  How to strategically fill gaps using literature, scientific guidelines, or new studies to meet IVDR standards.
• Unlocking Clinical Data for European Market Success
  What defines acceptable clinical data under IVDR and how to ensure ethical, traceable, and standards-based collection and reporting.
• Maximizing Efficiency in Notified Body Technical Documentation Assessments
  Proven strategies for structuring technical documentation to reduce assessment delays and improve review outcomes.

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Need help navigating IVDR?
Pure Global offers expert consulting support to help IVD manufacturers adapt their quality systems, validate clinical evidence, and prepare fully compliant technical documentation. From gap assessments to notified body engagement, our regulatory team can guide you through every stage of the IVDR transition with IVDR consulting support.

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