Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs
Agency IQ
JUNE 28, 2024
New guidance provides definition for orphan device, offers alternative trial designs New guidance from the European Commission outlines alternatives for full pre-market clinical trials for orphan devices, defined by the Commission for the first time. The need to document how and why a device qualifies as an orphan device (section 4.2)
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