2 août 2024 – The European Medicines Agency (EMA) has launched a pilot programme offering free expert panel advice on orphan medical devices in the European Union (EU), running until the end of 2025. This initiative supports manufacturers and notified bodies by providing guidance on orphan device status and clinical evaluation data. Orphan devices are designed for rare conditions affecting fewer than 12,000 individuals annually in the EU. The programme prioritizes devices for life-threatening conditions, pediatric use, and those with significant clinical benefits. In June 2024, new guidance from the European Commission clarified criteria for orphan devices. This pilot complements EMA's existing support for high-risk medical devices and aims to enhance innovation and accessibility for devices addressing unmet medical needs.

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