Orphan device (OD)

Orphan status does not lower the safety requirements, but MDCG 2024-10 lets notified bodies accept a more limited clinical data set at certification, balanced by stronger post-market clinical follow-up. The device must also meet a second criterion: a lack of adequate alternatives, or an expected clinical benefit over them.

For the purpose of this guidance, a medical device or an accessory for a medical device should be regarded as ‘orphan device’ (hereafter also referred to as ‘OD’), if it meets the following criteria: • the device is specifically intended to benefit patients in the treatment, diagnosis, or prevention of a disease or condition that presents in not more than 12,000 individuals in the European Union per year; and at least one of the following criteria are met: o there is insufficiency of available alternative options for the treatment, diagnosis, or prevention of this disease/condition, or o the device will offer an option that will provide an expected clinical benefit compared to available alternatives or state of the art for the treatment, diagnosis, or prevention of this disease/condition, taking into account both device and patient population-specific factors.

MDCG 2024-10, Section 4.1, Orphan device criteria