IVDR has changed what compliance looks like in diagnostics. What was once largely process-driven now depends on whether organisations have the right expertise in place to interpret requirements, generate evidence, and withstand Notified Body scrutiny. As transition deadlines approach, many companies are discovering that delays and risk aren’t caused by a lack of effort, but by gaps in capability. IVDR demands specialised regulatory, quality, and clinical skills and teams that can operate under tighter timelines and higher expectations. This guide examines how leading IVDR companies are responding: by aligning compliance planning with a clear talent strategy. It outlines what’s changed under IVDR, which roles have become critical, and why people's decisions now directly impact market access.
Understand which QA, RA, clinical, and manufacturing roles are essential under IVDR, and how leading companies structure responsibility to avoid gaps, bottlenecks, and burnout.
