Essentials of European Medical Device Regulatory Affairs

Vigilance – 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

– MDR Article 87 time lines are different- shorter. 2/7/10/15 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 )