Clinical microbiologists warned at ESCMID that Europe’s IVDR implementation may reduce patient access to diagnostic tests and constrain development of new assays. Stakeholders cited real-world strain from strict requirements, particularly for lab-developed tests and in-house developed assays. Speakers also pointed to bottlenecks tied to notified bodies, describing limited capacity to review diagnostics, and said the effective increase in tests needing review could slow availability. The session focused on how these constraints could worsen timeliness of testing and complicate lab–clinician workflows. The remarks land as EU labs continue transitioning under IVDR and seek operational flexibility while maintaining compliance.