At ESCMID, clinical microbiologists highlighted growing concerns that EU’s In Vitro Diagnostic Regulation (IVDR) may be constricting access to tests and slowing diagnostic development. Stakeholders described strains from strict IVDR requirements in laboratories, with particular impact on in-house developed and laboratory-developed testing. Speakers cited structural bottlenecks such as a shortage of notified bodies—reportedly only 10 to 12 of 50 regulatory agencies able to review diagnostics—and said the share of tests requiring notified body review has increased substantially. They also flagged difficulties categorizing tests within the IVDR risk schema. The session framed the issues as operational and regulatory rather than theoretical, warning that reduced test availability could erode clinician relationships and compromise timeliness of care.