Clinical laboratories and organisations 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 does this shift mean in practice for different organisations across the clinical diagnostics market?
In the fourth installment of our IVDR webinar series our experts review the impact of IVDR, outline some post-IVDR strategies for LDTs and address some key areas of concern for clinical diagnostic manufacturers. Our panel of experts 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.
Head of In Vitro Diagnostics & Principal Consultant,
Global Director – IVD Focus Team, TÜV SÜD
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