NOTIFICATION TO USERS
Field safety corrective actions are communicated to users by means of a field safety notice. Unless duly justified by the situation of the individual Member State, the content of the field safety notice must be consistent across all Member States. The field safety notice must explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons and clearly indicate all the actions to be taken by users.
Field safety notices for the territory of the Republic of Slovenia must be issued in Slovenian. The manufacturer must ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question.
Distributors/importers must cooperate with the manufacturer and the manufacturer’s authorised representative, as well as the competent authorities where appropriate, to ensure that the necessary corrective action is taken to bring the device into conformity, or to withdraw or recall it from the market, as appropriate.
Field safety notice template: most recent English version (also published on the EU Commission website) and older Slovenian version.
REPORTING TO JAZMP
The English form must be used to report a Field Safety Corrective Action (FSCA).
- Manufacturers, or their authorised representatives, must report any field safety corrective action (FSCA) undertaken in Slovenia to the JAZMP.
- Manufacturers, or their authorised representatives, established in the Republic of Slovenia must report any field safety corrective action to the JAZMP (even if the device in question has not been placed on the Slovenian market, or if the field safety corrective action does not concern the Slovenian market).
The reports in question, together with the corresponding Field Safety Notice (FSN) must be submitted in both English and Slovenian to the following electronic address: meddev.vigilance@jazmp.si.
