Reporting system for in vitro diagnostic medical devices

The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitro diagnostic medical devices (IVDs) and healthcare professionals in case of serious incidents, incidents other than serious incidents, and complaints involving IVDs after they have been placed on the market. Incident, Field Safety Corrective Action and Complaint Reporting Incidents Public or private healthcare professionals who, in the course of their activities, detect a serious incident , as defined by Article 2 of Regulation (EU) 2017/746 (consolidated text) , even if only suspected, involving an in vitro diagnostic medical device are required to notify the Ministry of Health, within the terms and in the manner reported in the regulations and in the Circular of November 29, 2022 . The communication shall be made directly or through the health facility where the reported incident occurred, in compliance with the provisions of the Decree of the Minister of Health of November 15, 2005 and the Decree of the Minister of Health March 31, 2022 . The communication must also be sent to the manufacturer or its authorized representative, including through the distributor of the in vitro diagnostic medical device. In the case of an accident other than a serious accident , involving an in vitro diagnostic medical device, public or private healthcare providers must notify the manufacturer or its authorized representative, including through the distributor, and may notify the Ministry of Health, in accordance with the procedures and timeframes set forth in the Circular of November 29, 2022. Existing European (Regulation (EU) 2017/746) and national (Legislative Decree 138/2022) regulations establish obligations regarding the supervision of incidents with in vitro diagnostic medical devices also for the manufacturer and other economic operators . In particular, the obligations for the manufacturer include reporting to the competent authority of all serious incidents, immediately after establishing the causal link , even if only reasonably possible, between the incident and their device ,and no later than the timeframes commensurate with the seriousness of the incident specified in Regulation (EU) 2017/746 (Article 82). The manufacturer is also responsible for the management of all incidents other than non-serious incidents. Lay users and patients who report incidents may notify the manufacturer or its authorized representative, including through the distributor of the device, at the same time as reporting to the Ministry of Health. Trend reports Manufacturers shall report trend reports ( Trend reports) to the Ministry of Health, i.e., any statistically significant increase in the frequency or severity of incidents other than serious incidents that may have a significant impact on the risk-benefit analysis and that have resulted or may result in unacceptable risks to the health or safety of patients, users, or other persons, or any significant increase in expected erroneous outcomes established in relation to the claimed performance of the device. Field Safety Corrective Actions and Safety Alerts The manufacturer, in the event that it highlights a possible hazard or risk associated with the use of a device, is required to voluntarily undertake field safety corrective actions , commensurate with the severity of the hazard, which may result in the issuance of new safety information or the withdrawal of the device from the market . It is also mandatory to report any Field Safety Corrective Action ( FSCA ) that has been taken to avert or reduce the risk of death or serious deterioration in health status associated with the use of an in vitro diagnostic medical device . Following the corrective safety actions, the manufacturer develops Field Safety Notices ( FSN ), addressed to end users, containing information on the corrective action taken. The Ministry of Health disseminates throughout the country, through publication on its portal, the safety notices in Italian language prepared by the manufacturers, who are primarily responsible for corrective actions, as required by national and European regulations. Periodic Summary Reports For similar serious incidents occurring with the same device or type of device and for which the root cause has been identified or safety corrective action has been taken, i.e., if the incidents are common and well documented, the manufacturer may submit periodic summary reports (PSRs) instead of individual serious incident reports. Complaints A complaint is a written, electronic, or oral communication stating deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a device or relating to a service that affects the performance of such devices (Legislative Decree Aug. 5, 2022, No. 138 ). The Circular of June 6, 2023, provides clarification and guidance for harmonized complaint handling across the country, with particular reference to the definition of complaint and the distinction between complaints and incidents. Public or private healthcare providers, either directly or through the healthcare facility involved, are required to report complaints to the manufacturer, including through the relevant economic operators, to enable measures to be taken to ensure protection and public health. Public or private healthcare providers, must report complaints at the same time to the Ministry of Health, for the purpose of data management activities, according to the terms and procedures provided by the Decree of the Minister of Health of January 26, 2023 . In the event of a complaint, in addition to the public and private healthcare provider, healthcare facilities, pharmacies, general practitioners or pediatricians of free choice are also required to make a report to the manufacturer. Lay users and patients report complaints to the Ministry of Health through the relevant health facility, pharmacy, general practitioner or pediatrician of free choice. Lay users and patients may report any complaints to the manufacturer, including through the relevant economic operators, such as agent, importer, distributor. The manufacturer is responsible for handling all complaints. The Circular of November 29, 2022 (Prot. No. 87235) provides operational guidance on how and when to report, concerning in vitro diagnostic medical devices, not only serious incidents and incidents other than serious incidents, but also complaints, safety corrective actions, and periodic summary and trend reports. All guidance is also outlined below. For operational guidance consult: Guidance for healthcare professionals Guidance for manufacturers.