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IVDR's Impact on EU Clinical Trials
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The article highlights how the In Vitro Diagnostic Regulation (IVDR) has affected clinical trials and CRO outsourcing in the EU, focusing on delays and mitigation strategies. The IVDR, in effect since May 2022, imposes rigorous safety and performance studies on medical devices, impacting drug trials using IVD tests.
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How are clinical trial timelines affected by the stringent IVDR requirements?
How might the IVDR influence the landscape of CRO outsourcing and trial locations in the long term?
What innovative strategies are being implemented to navigate IVDR-related delays?
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