Webinar - Best practices for bringing Laboratory Developed Tests (LDTs) through the IVDR conformity assessment process
Transforming Laboratory Developed Tests (LDTs) into IVDR-compliant CE-marked IVDs: Practical strategies and Notified Body insights for North American laboratories and manufacturers entering the European market.
North American IVD manufacturers and clinical laboratories are increasingly seeking to commercialize high-value assays originally developed as Laboratory Developed Tests (LDTs) or LDT-like tests for the European market. Under the EU In Vitro Diagnostic Regulation (IVDR, EU Regulation 2017/746), organizations face a significant transition: transforming internally validated clinical assays into compliant CE-marked IVDs capable of meeting rigorous regulatory and Notified Body expectations.
This practical webinar provides targeted guidance for North American organizations operating within Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), or ISO 15189 based environments that are preparing to transition LDT-derived assays toward IVDR-compliant CE marking. Led by experienced IVDR experts, the session will explore key regulatory and technical challenges related to performance evaluation requirements, classification considerations, technical documentation expectations, quality management system expansion, and practical strategies for navigating the IVDR conformity assessment process and Notified Body review expectations.
Attendees will gain real-world insights into common deficiencies observed during IVDR reviews and learn best practices to help accelerate successful CE marking under the IVDR framework.
Webinar details
- Date: Thursday, 9 July 2026
- Time: 9:00 -10:00 AM (PDT) | 12:00 - 1:00 PM (EDT)
- Speakers:
- Kenneth Fuh, IVDR Technical Manager and Auditor, DNV
- Elizabeth Bernal, Senior Auditor, DNV
- Key discussion topics:
- Leveraging existing validation and clinical data to support IVDR requirements for scientific validity, analytical performance, and clinical performance
- Understanding classification challenges that may place LDT-derived assays into higher-risk Class C or D categories
- Developing compliant technical documentation and Performance Evaluation Reports (PERs)
- Expanding quality management systems from CLIA or ISO 15189 foundations to meet full IVDR Annex IX or Annex XI expectations
- Clarifying when Article 5(5) in-house exemptions may apply, and when they do not, for commercially distributed assays
- Applying practical strategies to navigate Notified Body reviews and avoid common submission deficiencies
Whether your organization is preparing for its first IVDR submission or refining an existing commercialization strategy, this session will provide practical insights to help you navigate the pathway from internally validated assays to IVDR-compliant CE-marked IVDs.
Ahead of ADLM 2026, this webinar also offers an opportunity to better understand evolving IVDR expectations and connect with DNV experts supporting North American organizations entering the European market.
Register today to gain practical insights into IVDR conformity assessment expectations for LDT-derived assays and support your organization’s successful commercialization journey in Europe.