The Medical Device Coordination Group (MDCG) has clarified important vigilance terms and concepts used in the MDR in order to provide a common understanding of these terms and concepts necessary for an effective and harmonised implementation of vigilance requirements.
Some of the definitions have been reintroduced from the Medical Devices Vigilance Guidance, modified where necessary to be consistent with the MDR.
The eighteen-page document addresses a wide range of issues, including the difference between “incident” and “serious incident”, the basic criteria for reporting a serious incident, how incidents may ” indirectly lead to a serious deterioration of health”, and so on.
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