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.
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