Vigilance

Companies placing medical devices on the market are obliged to have an appropriate system of vigilance and post market surveillance (PMS) in place.

The following incidents must be reported:

• Any malfunction, failure or deterioration in the characteristics or performance of a device
• Any inadequacy in labelling or the Instructions for Use (IFU)

- which directly or indirectly lead to or may have led to the death of a patient or user or of another person, or lead to a serious deterioration in their state of health.

• Any technical or medical reason which may have lead to a batch recall of other similar devices.