The European Commission has published a new Guidance on clinical evaluation of orphan medical devices on June 26th.
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, and can be crucial to fulfil an otherwise unmet medical need.
We extend our deepest gratitude to the multiple IRDiRC members that contributed to the drafting of this guidance.
More information: https://health.ec.europa.eu/document/download/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf