Essentials of European Medical Device Regulatory Affairs - June 2020

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

TheOrganisation for Professionals in 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

TheOrganisation for Professionals in Regulatory 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

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