Orphan population

The manufacturer has to describe this population and support the figure of no more than 12,000 individuals in the EU per year with epidemiological data. The description sets the boundaries for the orphan status and for the intended purpose.

The manufacturer should provide a description of the specific disease/condition that presents in not more than 12,000 individuals in the EU per year for which the respective orphan device is intended to be used (hereafter referred to as ‘orphan population’).

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

The manufacturer should provide a description of the specific disease/condition, or of the specific test circumstance, that is present in not more than 12,000 individuals in the EU per year (hereafter referred to as the ‘orphan population’) for which the orphan IVD is intended to be used.

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

The IVD guidance (MDCG 2026-6) also allows the population to be defined by a specific test circumstance, while the device guidance (MDCG 2024-10) refers only to a disease or condition.