At ESCMID, clinical microbiologists raised concerns that implementation of the EU In Vitro Diagnostic Regulation (IVDR) is restricting patient access to tests and tightening development timelines. Presenters described a burden from regulatory classification, the strain of interpreting strict requirements, and bottlenecks tied to notified bodies. Erasmus Medical Center’s Erlangga Yusuf said notified bodies are a limiting factor for commercial test developers, noting only about 10–12 of roughly 50 agencies can review diagnostics while many focus on medical devices. He also cited a jump in the share of tests requiring notified-body review to 80% from 10%. Stakeholders argued that diminished lab flexibility and delays in diagnostic availability may erode relationships with clinicians and could worsen outcomes, particularly where rapid testing is central to antimicrobial stewardship.