EU MDR Section 2, article 87 mandats for reporting of serious incidents and field safety corrective actions. Thus manufacturers selling medical device in Europe are legally obligated to report any adverse events or incidents or if any recalls in the european terttroy. This process is called as vigilance reporting. Foreign manufactures are thereby advised to coordinate with European authorized representative for vigilance reporting.
According the guidance document MEDDEV 2.12/1 vigilance report means Incident Reports and Field Safety Corrective Action (FSCA) reports.
Patient death, serious injury, or may lead to death or serious deterioration in state of health if it were to reoccur majorly due to
in such cases the incident must be reported to the Competent Authority (CA) of the member state where the incident occurred.
The chain of activities to be covered includes Recall and Field Safety Corrective Action (FSCA) taken by the manufacturer to reduce the possible risk of death or any such serious deterioration in health. Recall and FSCA must be distributed to Cas of the member states where the device is sold and used as also to be EAR responsible appointed by the manufacturer.
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