The Mirror-MDCG-Clinical Working group, which includes members of 11 NBs, created this position paper. It was distributed to all NBs via CIRCABC. It has received approval from the Team-NB general assembly.
Off-label usage is addressed in the Medical Device Regulation (MDR) in Annex XIV Part B, but it is not defined there. Manufacturers are expected to proactively discover misuse or off-label uses of their products through PMCF operations.
Many definitions related to pharmaceuticals can be found by searching “off-label usage definition,” however few definitions particularly related to medical devices can be found. Off-label usage, however, might be interpreted broadly speaking.