Common and well documented serious incident

Under Article 87(9) MDR and 82(9) IVDR, such incidents can be reported in periodic summary reports if the competent authority agrees. The incident and its root cause must already be well understood, so a new incident type cannot qualify.

A ‘common and well documented serious incident’ as referenced in Article 87(9) MDR/Article 82(9) IVDR, must be clearly identified in the manufacturer’s risk analysis and should have led to incident reports, which have been assessed by the manufacturer and the relevant competent authority. The serious incident and the root cause should be clinically well-known (i.e. a certain qualitative or quantitative predictability is established) by the manufacturer.

MDCG 2023-3 Rev.2, Question 24