Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs
Agency IQ
JUNE 28, 2024
See here for an in-depth analysis of those recommendations , but in short, CORE-MD presented findings from research about the impact of the MDR on certain high-risk medical devices. The device description should include information about the current state of the art treatment options and any alternative device choices. Appendix A.2
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