| Accident Any dysfunction or deterioration that directly or indirectly causes a serious deterioration of health or death |
| MISSED ACCIDENTS Any dysfunction or deterioration that directly or indirectly causes a serious deterioration of health or death |
| THE MANUFACTURER Is obliged to make an immediate report to the Ministry of Health and prepare for the possible recall of the device from the market |
| THE PUBLIC HEALTH AUTHORITY Has the task of recording and assessing the data on the accidents and missed accidents reported |
| MEDICALOPERATORS Are obliged to report any accidents or missed accidents |
| THEINDIPENDENTORGANISATIONWICHEMITTEDTHE“CE”CERTIFICATION Can be consulted by both the Public Health Authority and the manufacturer |
