Manufacturers must report statistically significant increases in the frequency or severity of “expected undesirable side effects” that could lead to unacceptable risks to the health and safety of patients, users, or others, or that could have a meaningful impact in the benefit-risk analysis. This includes situations where the side effects are compared to the intended benefits of the device. These reports are made through the electronic system referenced in Article 92 (Vigilance and post-market surveillance electronic system).

A significant increase is determined by comparing the frequency or severity of such adverse events, over a specific period, with the expected frequency or severity as defined in the technical documentation and product information. Trend reporting applies to all product classes.