Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs
Agency IQ
JUNE 28, 2024
The working definition offered at that meeting focused on devices intended to treat or diagnose patients for diseases or conditions affecting no more than 1 in 37,000 Europeans per year. Those criteria are that the device is intended to benefit patients with a disease or condition present in 12,000 or fewer people in the E.U.
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