Vigilance

The Irish Medicines Board (IMB) as the Competent Authority (CA) is obliged to institute and coordinate a reporting system for adverse incidents associated with the use of medical devices in Ireland. Detailed guidance on the vigilance system can be obtained from the following guides:

The vigilance activity of the IMB includes the monitoring of the investigation into incident being carried out by the manufacturer and by taking any further action that may be necessary to supplement the actions of the manufacturer. Also depending on the outcome to the investigation, any information necessary for the prevention of further incidents (or the limitation of their consequences) will be disseminated by the national Competent Authority to relevant stakeholders. The system is intended to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in the European Economic Area (EEA) and to correct product problems.

The IMB encourages the reporting of incidents by the user and other professionals. Any incidents reported are held in confidence, as defined by the relevant articles of the Directives.

For more information on the safety of medical devices, go to the safety notices page or contact the Vigilance and Compliance Section of the IMB at vigilance@imb.ie. Manufacturers and users may report incidents to the IMB using the reporting forms which can be found in the publications section.

The Irish Medicines Board - www.imb.ie

Vigilance