Safety related notifications
A field safety corrective action is an action taken by a manufacturer or his authorised representative to reduce a risk of death or serious deterioration in the state of health associated with the use of medical device that is already placed on the market.
A manufacturer of medicinal devices or his authorised representative must inform JAZMP and users of medicinal devices in writing regarding field safety corrective actions. Information on a field safety corrective action is submitted to users in the form of a field safety notice. Field safety notice for the territory of the Republic of Slovenia must be written in the Slovene language and must contain information as described in the Rules on vigilance regarding medicinal devices (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 61/10) or as defined on the form MedPri-VIG-obr04 Field Safety Notice template.