IVDR Process Overview with Case-study on IVDR Implementation for Custom LDT Assays, Upcoming Webinar Hosted by Xtalks

In this free webinar, gain insight into method development and optimization of custom Laboratory Developed Test (LDT) assays, including critical steps identification and risk mitigation. Attendees will learn about design control, including systematic qualification of reagents, consumables and assay parameters to ensure method robustness. The featured speakers will share insights about method validation and implementation, including performance assessments (precision, sensitivity, specificity and threshold determination) against predefined acceptance criteria. Attendees will learn about proficiency testing and IVDR-compliant technical dossier preparation for CE marking.

TORONTO, May 20, 2026 /PRNewswire/ -- The implementation of the In Vitro Diagnostic Regulation (IVDR) has significantly transformed the regulatory and operational landscape for laboratories developing and using Laboratory Developed Tests (LDTs). In particular, laboratories working with custom assays must now demonstrate robust design control, clearly defined performance characteristics and comprehensive technical documentation aligned with IVDR expectations. This webinar provides a practical and end-to-end overview of the IVDR compliance process for LDTs, illustrated through a case study focused on implementing IVDR requirements for custom LDT assays.

Attendees will gain a structured understanding of how to approach method development and optimization, with an emphasis on identifying critical assay steps, understanding sources of variability and applying effective risk mitigation strategies early in the development lifecycle. The session will explore how IVDR design control principles can be applied in practice to systematically qualify reagents, consumables and assay parameters, ensuring assay robustness, reproducibility and regulatory readiness.

The webinar will also address method validation and implementation under IVDR, outlining best practices for defining performance evaluation strategies and acceptance criteria. Key validation parameters, including precision, sensitivity, specificity and threshold determination, will be discussed in the context of IVDR regulatory expectations. Through a practical case study, participants will learn to translate validation data into compliant and defensible documentation.

In addition, the session will clarify IVDR requirements for proficiency testing and provide practical guidance on preparing an IVDR-compliant technical dossier to support CE marking of custom LDT assays. Common challenges, pitfalls and lessons learned from real implementation experience will be shared to help laboratories reduce regulatory risk and avoid rework.

Register for this webinar to learn how IVDR compliance for custom LDT assays supports method validation, technical documentation and CE marking.

Join experts from Cerba Research, Lorella Di Donato, Chief Laboratory & Operations Officer; Martin Roberge, PhD, Director, Development & Innovation; and Marie-Laure Delalande, Head of IVD Operations, for the live webinar on Tuesday, June 9, 2026, at 11am EDT (5pm CEST/EU-Central).

For more information, or to register for this event, visit IVDR Process Overview with Case-study on IVDR Implementation for Custom LDT Assays.

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