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.
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