Vigilance

Although medical devices undergo rigorous testing during the approval process, adverse events can occur due to a variety of reasons (i.e. bilateral influence of two medical devices, reactivity of two substances).In order to better estimate the frequency, severity and impact of such errors, law regulates the establishment of vigilance systems for medical devices.

A vigilance system includes a multitude of processes that must be complied with during market observation. Besides the definition of reportable events (e.g. malfunctions in the case of appropriate use) and the type of notification, law also regulates the reporting frequency and scope of a vigilance system. For example, serious adverse events threatening public safety must be reported immediately (and without undue delay) to the competent authority within a maximum of two calendar days. Moreover, negative trends (e.g. increased occurrence of side effects) or misuse leading to serious deterioration of health or death have to be reported.

In addition to the report on the frequency and severity of adverse events, a vigilance system also requires a problem-solving strategy. This may involve contacting the users of faulty equipment, informing medical and nursing staff about any misuse that has occurred, or conducting evaluations to assess the need for further corrective actions.

The characteristics of a vigilance system clearly demonstrate its importance in maintaining patient safety. This also explains why there is a multitude of new or revised laws, regulations and directives regulating the field of vigilance at national and European level.

CCMD would like to support you in complying with the legal framework of a vigilance system. Through the development of individual strategies, by supporting you with the implementation of system processes and by offering you appropriate tailor-made solutions, we can help you with managing time-critical processes. Thus, we support you to compensate personnel shortages induced by the statutory requirements of such systems and help you to prevent potential delays.