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FIELD SAFETY CORRECTIVE ACTION

Friday 27 June 2014 , by (Rene Clement)

Recall: How, When and by Whom the NCA should be notified?

ANSWER:
With the exception of the aforementioned early-stage FSN approval, CA notifications should be made, if not before, then at the same time as the recall action. Your company’s AR is responsible for these notifications.
Upon receiving the FSN, the AR must prepare a Field Safety Corrective Action report for each affected country. A template for the report is included in MEDDEV 2.12-1 rev 6. The report should include the number of recalled devices per country and an appended English-language FSN.
Upon approval by the manufacturer, the AR will send out the notifications. The representative is also responsible for diligently maintaining records showing that the notifications were correctly
transmitted