Vigilance & Medical Device Reporting

Qserve supports your EU medical device adverse incident and FSCA reproting process

Medical Device Vigilance in Europe

The European Medical Device Directive (MDD) state that medical device manufacturers are legally required to report advertse incidents and Field Safety Corrective Actions (FSCAs) to the EU Competent Authorities.

The purpose of the Medical Device Vigilance System is to improve the protection of Health and Safety of patients, healthcare professionals, and other users by reducing the likelihood of reoccurrence of incidents related to the use of a medical device.

Companies that fail to correctly report incidents could face severe consequences. There is no acceptable excuse for not reporting incidents, so manufacturers need to be pro active.

If a manufacturer takes an action to reduce the risk of serious deterioration in health, such as a recall, a Field Safety Corrective Action (FSCA) report must be distributed to Compertent Autority where the device is being marketed.

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