Clinical evaluation (Art. 61 + Annex XIV)
MDR Art. 61 and Annex XIV. Clinical evaluation is mandatory for all MDR devices regardless of class. It is a continuous, lifecycle process — not a one-time pre-market exercise.
MDR Art. 61 and Annex XIV. Clinical evaluation is mandatory for all MDR devices regardless of class. It is a continuous, lifecycle process — not a one-time pre-market exercise.