Orphan devices are medical devices or their accessories, which are intended to be used for diseases or conditions affecting only a small number of individuals each year. Often, they are used to treat a rare disease or medical condition for which very few diagnostic or therapeutic options exist. Orphan devices can be crucial to fulfil an otherwise unmet medical need.
This guidance was developed by the Medical Devices Coordination Group (MDCG), which is made up of representatives of the Member States and chaired by the Commission. It was done in collaboration with stakeholder representatives including health care professionals, academic societies, notified bodies and industry.