The Medical Devices Introductory Course 2020

Vigilance Current (transitionary) state 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

The Organisation for Professionals in Regulatory Affairs

Vigilance

However… As of 1 st Jan 2019 we are transitioning to a new reporting format, designed to reflect both the new requirements (MDR & IVDR) AND the existing requirements (MDD & IVDD)..

The New manufacturer incident report (also known as Manufacturers Incident Report Form) is mandatory as of 1 st Jan 2020

Help can be found in the guidance document.. New manufacturer incident report helptext

The Organisation for Professionals in Regulatory Affairs