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
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