Regulatory Headwinds: Navigating the IVDR and LDT Rule in the In Vitro Diagnostics Market Restraints
While the In Vitro Diagnostics (IVD) Market is driven by innovation, a major In Vitro Diagnostics Market Restraints is the increasing stringency and complexity of the global regulatory landscape. The most significant recent challenges come from the European Union’s In Vitro Diagnostic Regulation (IVDR) and evolving rules governing Laboratory Developed Tests (LDTs) in the U.S. The EU IVDR...
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