Question: The Medical Device Reporting ( MDR ) Regulation ( 2 1 CFR 8 0 3 ) requires that all manufacturers report to FDA whenever a

The Medical Device Reporting (MDR) Regulation (21 CFR 803) requires that all manufacturers report to FDA whenever a device:
may have caused or contributed to a death or serious injury
may have caused or contributed to the recovery of a patient
has correctly functioned and would be likely to cause or contribute a recovery and well being
has correctly functioned and would be likely to cause drowsiness

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