Essentials of European Medical Device Regulatory Affairs - October 2019

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 157

Vigilance Electronic Reporting Where does the information go?  Automatic transfer of report

Report

CA

Serious incident

MS where the incident occurred NB  MS(s) where the incident(s) occurred NB MS(s) where the FSCA takes place MS of the manufacturer/AR NB MS (s) in coordination procedure MS of the manufacturer/AR NB

Trend reports

FSCA

Periodic Summary Reports

158