Rare disease

MDCG 2024-10 on orphan devices refers to this EU definition. It helps frame when a device serves a population so small that the clinical evidence expectations take into account how few patients are available for studies.

Pursuant to the Council Recommendation of 8 June 2009 on an action in the field of rare diseases (OJ C 151, 3.7.2009, p. 7), for the purpose of Union-level policy work a common definition of ‘rare disease’ as a disease affecting no more than 5 per 10,000 persons should be used.

MDCG 2024-10, Section 4.2.1, footnote 6 (Council Recommendation of 8 June 2009)