Medical device safety information
The manufacturer or authorised representative of the manufacturer of a medical device must notify the Agency for Medicinal Products and Medical Devices in writing of any corrective action it intends to carry out in order to reduce as far as possible the possibility of a recurrence of an adverse incident concerning the medical device.
In addition to notifying the Agency, the manufacturer or authorised representative of the manufacturer of a medical device must notify users about the corrective action by providing safety information using a method that guarantees that all users are notified. The safety information should be in Croatian language and include the elements set out in Annex III of the Ordinance on Monitoring Adverse Incidents Related to Medical Devices (Official Gazette, no. 125/13).
We present received safety information notifications below.