Essentials of European Medical Device Regulatory Affairs - June 2020

Vigilance Serious incident (article 2 (65)) Any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat ; Serious public health threat (article 2 (66)) An event which could result in imminent risk of death, serious deterioration in a person's state of health, or serious illness, that may require prompt remedial action , and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;

112

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

113

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 establishedor suspected Immediately causal relationship establishedor suspected Immediately causal relationship established (or reasonably possible)

10 days

Unanticipated serious deterioration in health

10 days

Other Serious incidents

15 days

FSCA

Before implementing (unless FSCA is urgent)

-

Submit an initial report, don’t wait for all the information, you can send a follow up report.

TheOrganisation for Professionals in Regulatory Affairs

38