Impacts of European In Vitro Diagnostic Regulation (IVDR) - Head of Clinical Microbiology and Clinical Biomarker Platform, French Academic Medical Center

The head of clinical biomarkers and microbiology at a French academic medical center shares their perspective on how IVDR is impacting their lab and country . The stakeholder expresses mixed sentiments about IVDR, which they describe as closely resembling the FDA’s system and more stringent than the previous In Vitro Diagnostic Directive (IVDD). On the positive side, they note that the introduction of IVDR improves the quality of diagnostics by mandating that labs meet market standards. This in turn boosts faith in the diagnostic process, helping to eliminate subpar systems and ensures laboratories use higher quality reagents. However, on the downside, the stakeholder argues that IVDR is a 'killer for innovation.' The enforcement of IVDR has led to increased development costs and longer timelines, making it harder for new tests to reach the market. This is particularly challenging for smaller companies, which previously used Europe as a testing ground before moving to stricter regulatory environments like the U.S. Looking forward, they note that the implementation of IVDR has become a reality for major reagent suppliers and that the standards will closely align with the FDA's

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