As part of the requirement for post-medical Surveillance systems, the Medical Device Directives quality system and verification annexes require that the manufacturer report certain adverse events, incidents or corrective actions associated with the use or function of devices to Competent Authorities. In addition to these reports, the Health and Youth Care Inspectorate receives reports from care providers and from members of the public.
Vigilance reports are an important source of information for supervision
Every report is dealt with separately, where possible in conjunction with other information. The reports constitute an important source of information for the Inspectorate's supervision of the safe working and application of medical products and the weighting of their risks/benefits. After all, there is always a risk of complications or incidents whenever a medical device is used. The risks must be weighed up against the likely advantages of using the medical device.
Manufacturer is responsible for product safety
In the first instance, manufacturers are responsible for properly monitoring these risks/benefits and for assuring the safety of their products. Under European regulations, they are under obligation to carry out post-market surveillance, which means that the manufacturer must monitor on safety after introducing a medical device into the market. In response to some reports, we may start an investigation or may take enforcement measures.