Incident Report for Medical Devices
According to article 11 of Act no. 16/2001 on medical devices manufacturers, suppliers and users are obliged to report to IMA any malfunction or deterioration in the characteristics and/or performance of a device which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health.
- Manufacturers and suppliers shall fill out and send to IMA following report of incident
- Owner or user shall fill out and send to IMA following form