Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs
Agency IQ
JUNE 28, 2024
BY COREY JASEPH, MS, RAC | JUN 26, 2024 11:15 PM CDT Quick background on clinical evaluation and investigation requirements under the European medical device regulation The E.U. The device description should include information about the current state of the art treatment options and any alternative device choices.
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