All manufacturers are legally bound to report any serious or potentially serious incidents involving devices they produce or sell.
A device user facility must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. Device manufacturers and importers must also report deaths and serious injuries that their device has or may have caused or contributed to. In addition, they must report certain device malfunctions, and establish and maintain adverse event files.
The principal purpose of the Medical Device Vigilance System is to improve the protection of health and safety of patients, users and others by reducing the likelihood of reoccurrence of the incident elsewhere. This is to be achieved by the evaluation of reported Incident's and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such incidents.
Legal manufacturers should initiate and control a MDR procedure describing a system for the notification and evaluation of adverse incidents to be known as the Medical Devices Vigilance System. The company must report certain types of incident, recalls and notifications to National Competent Authorities & Regulatory Authorities.
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