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.

As North American laboratories and IVD manufacturers expand into the European market, many are facing the challenge of transforming Laboratory Developed Tests (LDTs) into IVDR-compliant CE-marked in vitro diagnostic medical devices (IVDs).

Under the EU In Vitro Diagnostic Regulation (IVDR 2017/746), organizations operating within CLIA, CAP, or ISO 15189-based environments must navigate significantly different regulatory, technical, and quality management expectations to achieve successful CE marking and market access in Europe.

This practical webinar will provide targeted guidance for North American organizations seeking to commercialize LDT-derived assays in the EU market. Led by our experienced IVDR experts, the session will explore key regulatory and technical challenges associated with transitioning Laboratory Developed Tests (LDTs) into IVDR-compliant CE-marked IVDs, including 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

 

Topics covered

Participants will learn about:

  • Leveraging existing validation and clinical data to support IVDR requirements for scientific validity, analytical performance, and clinical performance
  • Understanding classification challenges that frequently place LDT-derived assays into higher-risk Class C or D categories
  • Developing compliant technical documentation and Performance Evaluation Reports, particularly where clinical evidence or real-world data may be limited
  • 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 review processes and avoid common deficiencies that delay submissions

 

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.