Non-orphan

The term matters when a device has both orphan and non-orphan indications. The orphan approach to clinical evidence applies only to the orphan part, so the non-orphan indications need the usual evidence.

Refers to a device, indication, or (sub)population which does not meet the definition of “orphan device”, “orphan indication”, or “orphan (sub)population”, respectively

MDCG 2024-10, Section 1, Abbreviations and terminology

Refers to an IVD, indication, or (sub)population which does not meet the definition of ‘orphan IVD’, ‘orphan indication’, or ‘orphan (sub)population’, respectively

MDCG 2026-6, Section 1, Abbreviations and terminology