The Italian Ministry of Health has implemented new online reporting procedures in its official web-site in order to simplify the IVDDs post-market vigilance activities.
This procedure is based on an online form to be filled in with all adverse event information and submitted by healthcare professionals in a very easy way.
It is important to remember that the healthcare professionals play a key role in the post-market vigilance activities. They are responsible for the communication to the Manufacturer and the Regulatory Authority for:
– adverse events that have caused death or serious injuriy of the patient or the operator involved;
– alterations of features and performances of the device;
– missing statements in instructions for use.
Goal of the Ministry of Health is to collect more exhaustive and appropriate data in order to properly supervise and control the relevant activities.
For further information: