Essentials of European Medical Device Regulatory Affairs

Vigilance

The vigilance report ( also known as Manufacturers Incident Report Form ) • Initial – sent first, to notify the appropriate competent authority of the incident • Final – root cause is known, investigation is complete – It may be possible, to combine the initial report with the final report • Intermediate or Follow-up Report – It is also possible to submit intermediate reports , used to update the appropriate CA on the progress of an investigation

Vigilance

MANUFACTURER RESPONSIBILITY – Staying up to date with regulatory requirements and regulator expectations – Establishing a process that meets these requirements – Embedding this process into the Quality Management System – This means:- • The manufacturers QMS • Training / implementation • Any delegation is controlled & documented with evidence of effectiveness

– Ensuring that requirements are adhered to – ISO13485, 8.22 – Monitoring the effectiveness of this process – ISO13485, 8.1