Essentials of European Medical Device Regulatory Affairs

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

The Organisationfor Professionals inRegulatory Affairs

Vigilance

After the initial report….  Investigations by the manufacturer – Risk assessment – FSCA – Cooperation with CAs and NB  Upload Full report with conclusions and corrective actions  Send FSN to users – Devices (UDI) and Manufacturer (SRN)

– Reasons for the FSCA – Risks and level of risk – All actions to be taken by users – Translations(s)

 Upload FSN

The Organisationfor Professionals inRegulatory Affairs