I started triaging this internally when a procurement lead casually asked if our change-control record could be handed to a hospital HTA team "next week." That moment made the regulatory shift real: EUDAMED visibility plus increasingly formal HTA paths in Germany are colliding into the QMS, and it’s not just paperwork — it’s data, interfaces, and traceability. Below I summarize what I’m seeing in 2026, how it affected our Class II/IIa workflows, and the concrete engineering/validation moves w...