With Circular No. 59712 of 21 July 2026, the Italian Ministry of Health introduced a new digital system for managing complaints related to medical devices, MDR Annex XVI products, and in vitro diagnostic medical devices (IVDs). SCF provides a focus of the Circular’s key provisions and the operational changes introduced for healthcare and industry stakeholders.
The aim of the new procedure is to simplify and standardize the collection of complaints, while enhancing surveillance and monitoring activities carried out by the competent authorities.
A complaint is defined as any written, electronic, or verbal communication reporting deficiencies related to the quality, safety, reliability, usability, or performance of a medical device.
As of 22 July 2026, public and private healthcare professionals, healthcare facilities, pharmacies, general practitioners, and primary care pediatricians are required to submit complaints to the Italian Ministry of Health through the new dedicated online reporting system. Complaints must be submitted within 30 days of becoming aware of the event.
It also remains important to notify the device manufacturer in accordance with the procedures established by the manufacturer, thereby facilitating the timely management and investigation of the reported issue.
