The Medical Devices Introductory Course 2020

Vigilance

STEP THREE – REPORTING

IMMEDIATELY

but no later than:-

● 2 days, if the reportable event(s) is deemed to be a serious public health threat ● 10 days, if the reportable event has caused death of a patient, USER or other person, or a serious deterioration in state of health of a patient, USER or other person ● 30 days, if, should the event re-occur , involving the same or a similar device, it could lead to the death of a patient, USER or other person, or a serious deterioration in the state of health of a patient, USER or other person ● However…. Remember MDR Article 87.. – 30 days becomes 15 days !!

Vigilance

To the Competent Authority

● In the country where incident occurred, or ● In the country where EU AR or MANUFACTURER has his registered place of business (when the event is related to information coming from sources other than an incident)

To the Notified Body

● If involved in the conformity assessment of the device ● At the same time as sending the vigilance report to the CA (unless alternative arrangements have been agreed with your NB )

The Organisation for Professionals in Regulatory Affairs