The Medical Devices Introductory Course 2020

Vigilance

STEP TWO – THE DECISION

The legal manufacturer will complete the decision tree, ensuring that:-

● Appropriate resources are used ● Outcome of all decisions is clearly recorded ● Completed decision tree is signed and dated ● Completed decision tree is readily retrievable

If a vigilance report is necessary, the legal manufacturer shall ensure that:-

● An Incident Report Form is completed in full ● The completed report is sent to the appropriate EU Competent Authority and Notified Body (if applicable)

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 *Must: All 3 criteria together considered as an INCIDENT (Ref MEDDEV 2.12-1 rev8, 5.1.1)