Essentials of European Medical Device Regulatory Affairs - October 2019

Vigilance Field safety corrective action: (article 2 (68)) FSCA Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market Examples: - device return / exchange / destruction - Device Inspection /examination by the user - Device Modification (includes upgrades for software faults) - Changes to labelling/IFU Field safety notice (article 2 (69)) FSN A communication sent by a manufacturer to users or customers in relation to a field safety corrective action

155

Vigilance Reporting Timelines

Clock starts when manufacturer becomes aware Type of event  When to report Maximum Serious public heath  threat Immediately 2 days Death Immediately causal relationship  established or suspected 10 days

Unanticipated serious  deterioration in health

Immediately causal relationship  established or suspected

10 days

Other Serious incidents Immediately causal relationship  established (or reasonably possible)

15 days

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FSCA

Before implementing (unless FSCA is urgent)

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