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 (only works in Internet Explorer)

  • Owner or user shall fill out and send to IMA following form

New MIR form applicable from January 2020

New incident form for manufacturers, which will take effect on January 1st 2020