Periodic summary report (PSR)

A PSR needs agreement with the coordinating competent authority and fits, for example, incidents whose root cause is known and whose corrective action is in place. It reduces repeated individual reports but does not reduce the obligation to investigate and trend them.

A ‘Periodic Summary Report’ (PSR) is an alternative reporting regime by which the manufacturer, in agreement with the respective national competent authority that is coordinating the periodic summary reporting (and in consultation with the competent authorities referred to in Article 92(8)(a) MDR/Article 87(8)(a) IVDR), can report similar serious incidents with the same device or device type in a consolidated way. Criteria for periodic summary reporting include situations where; the root cause has been identified, a FSCA has been implemented or where the serious incidents are common and well documented.

MDCG 2023-3 Rev.2, Question 23