Under the terms of the Irish Medical Devices Regulations, 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. 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 vigilance system is the name given to the process of notification and evaluation of adverse incidents associated with medical devices. It should also be pointed out that any adverse affects occurring during clinical investigation or performance evaluation should be reported to the CA.
As required by the directives the following types of incidents and recalls should be reported by the manufacturer to the Irish Medicines Board:-
- Any malfunction of or deterioration in the characteristics and performance of a device as well as any inaccuracies in the instruction leaflet, which might lead to or might have lead to the death of a patient or to the deterioration in health
- Any technical or medical reason due to risk of serious injury or death resulting in the recall of a device from the market by the manufacturer or the issue of an advisory notice
Suggestions as to the type of incidents to be reported are provided in the European Commission Guidelines MEDDEV 2.12-1 Rev 6 Guidelines on a Medical Devices Vigilance System.
Vigilance can be carried out in a number of ways:
Further information on the above is available in IMB guidance documents which can be found in the 'Publications' section of this website, under Medical Device - Guidance.