Orphan subpopulation

This route lets a device for a small subgroup of a common disease use the orphan approach. The manufacturer has to justify why the subgroup is clinically valid and not just a convenient slice of the larger population.

The manufacturer may also justify that the device is intended to be used to benefit patients in the treatment, diagnosis, or prevention of a disease or condition that presents in a clinically valid patient sub-population (not more than 12,000 individuals in the EU per year) within a disease or condition with an annual incidence of more than 12,000 in the EU (hereafter referred to as an ‘orphan subpopulation’).

MDCG 2024-10, Section 4.2.1, Epidemiology of the disease or condition

The manufacturer may also justify that the IVD is intended to test individuals for a disease/condition/circumstance that presents in a clinically valid patient subpopulation (not more than 12,000 individuals in the EU per year and hereafter referred to as an ‘orphan subpopulation’) within a disease/condition/circumstance with an annual incidence of more than 12,000 in the EU.

MDCG 2026-6, Section 4.2.1, Epidemiology of the disease/condition/circumstance