In brief
On 16 April 2022, the Decree of the Ministry of Health dated 31 March 2022 (“Decree“) establishing the national network for device-vigilance and the supporting information system was published in the Official Gazette.
- The purpose of the national network for device-vigilance is to ensure the timely and widespread exchange of information on incidents and safety actions involving medical devices, in vitro diagnostic medical devices, and products listed in Annex XVI of Regulation EU 745/2017 that, although are not intended for medical purpose (e.g., contact lenses, equipment for liposuction, lipolysis or lipoplasty, substances intended to be used for facial or other dermal filling, etc.), are still subject to the provisions of the above Regulation.
- From an operational standpoint, the network involves the following subjects that are entrusted with specific functions: (i) healthcare professionals, who detect incidents in the performance of their duties; (ii) local supervisory managers, who support healthcare professionals in reporting incidents, evaluating and validating reports, informing manufacturers of incidents, and providing information about possible safety measures; (iii) regional supervisory managers, who monitor and coordinate the vigilance activity in their region and act as a point of contact between local supervisory managers and the Ministry of Health; and (iv) the Ministry of Health, which carries out all the activities required by the EU and national regulations on device-vigilance and ensures coordination with other competent authorities.
- In addition, regions and autonomous provinces must ensure the functioning of the vigilance network by coordinating the same network within their respective territories and identifying those responsible for handling incident reports.
