Essentials of European Medical Device Regulatory Affairs

Vigilance

Periodic Summary Reporting Is an alternative reporting regime agreed between the MANUFACTURER and the National COMPETENT AUTHORITY for reporting similar INCIDENTs with the same device or type in a consolidated way where the root cause is known or an FSCA has been implemented This is being introduced in MDR #87 para 9. Trend Reporting MDR #88 A reporting type used by the MANUFACTURER when a significant increase in events not normally considered to be INCIDENTs has occurred and for which pre-defined trigger levels are used to determine the threshold for reporting

Vigilance There are 3 primary criteria which define whether a vigilance report is necessary

• An event has occurred and

• The manufacturer’s device is suspected to be a contributory cause of the event and

• The event led, or might have led, to death or serious deterioration (injury) in state of health

– Document any decision or rules defined for reporting a particular issue.

(Ref MEDDEV 2.12-1 rev8, 5.1.1)