IVDR and the future of lab developed tests and clinical diagnostics

Clinical laboratories and organizations running lab developed tests (LDTs) will be operating in an increasingly complex regulatory environment under the European In Vitro Diagnostic Regulation (IVDR). Under the new regulations, clinicians will not have the option to use an LDT if a comparable certified IVD is commercially available. This change will go into effect immediately in May 2022. What will this shift mean in practice for different organizations across the clinical diagnostics market?

In our series looking at the impact of IVDR, guest speakers will outline some post-IVDR strategies for LDTs and address some key areas of concern for clinical diagnostic manufacturers. Our panel of experts will examine the implications of IVDR on the future of LDTs in more detail, including some of the in-house exemption requirements and the implications of ongoing clinical studies that will end after the date of application.

Key questions answered:

• What are the requirements for clinical diagnostics in Europe post-IVDR?
• What will the impact be of IVDR on testing conducted outside the EU, including any transitional issues?
• What are the conformity routes for distance sales?
• Will LDTs still exist after IVDR?

Who should attend:

• Stakeholders in molecular diagnostics, IVD manufacturers and clinical labs globally, including: R&D, quality, and operational staff.