A field safety corrective action is a corrective action taken by a manufacturer due to, for example, device malfunction and the associated risks for patients, users or other persons. The medical device manufacturer or its authorised representative must notify both the JAZMP and the device users about the field safety corrective actions by written communication.
A field safety corrective action is communicated to the users using a field safety notice. A field safety notice for the territory of the Republic of Slovenia must be issued in Slovenian.
On its website, the JAZMP publishes field safety notices it receives from manufacturers or their authorised representatives on a monthly basis.
The list of field safety notices may be incomplete, so if you receive a notice that is not included in the monthly updated list, please let us know at:
