Article EMA Thank You New guidance provides definition for orphan device, offers alternative trial designs
Agency IQ
JUNE 28, 2024
In the post-market space, the group offers guidance on creating a post-market clinical follow-up (PMCF) plan, which confirms product safety and performance and identifies emergent risks ( MDCG 2020-7 ). Some of these are laboratory and animal tests, cadaveric studies and data from similar devices.
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