Unexpected undesirable side-effects

Unlike expected side-effects, which are monitored through trend reporting, an unexpected side-effect with a serious outcome is reported individually as a serious incident. Finding one should also prompt an update of the risk analysis and the product information.

Unexpected undesirable side-effects are not considered in the manufacturer’s risk analysis, quantified in the manufacturer’s technical documentation or documented in the product information.

MDCG 2023-3 Rev.2, Question 10