While MDR has placed high demands on medical device manufacturers, a new reality is emerging in healthcare. AI‑based triage tools, prioritization systems, and digital clinical assistants are increasingly shaping clinical decisions – yet are often introduced as “IT support,” without equivalent regulatory scrutiny.
When AI‑driven tools influence patient flows, assessments, and clinical priorities, treating them as mere administrative systems risks undermining both patient safety and fair competition.
Indeed, the real threat to safe medical technology may be what falls outside the regulatory framework.
In her latest column in Medtech Magazine, Anna-Karin Alm, Head of QARA at Aurevia, calls for a reassessment of how we define medical technology—focusing on real clinical impact rather than labels.
A must‑read for anyone involved in regulatory strategy, patient safety, and digital health innovation.
Read the full article at Medtech Magazine (in Swedish)
