Essentials of European Medical Device Regulatory Affairs

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 Immediately causal relationship established or suspected

10 days

Unanticipated serious deterioration in health

10 days

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

15 days

-

FSCA

Before implementing (unless FSCA is urgent)

The Organisationfor Professionals inRegulatory Affairs

Vigilance

Periodic Summary Reporting (article 87) • Alternative to individual reports • Similar serious events on the same device /device type – Root cause identified or – FSCA implemented – Common and well documented • CAs agree with format, content and frequency Trend Reporting (article 88) • Incidents that are not serious incidents or Expected undesirable side effects – Significant impact on benefit – risk and – Have led or may lead to risks to health and safety which are unacceptable when compared to the benefits • Methodology is included in the PMS Plan • CAs can require measures

The Organisationfor Professionals inRegulatory Affairs