Quality Management
Open question
Trend reporting is a PMS input or output?
Anonymous
·
Published June 10, 2026
Annex III of MDR:
- The PMS plan shall address the collection and utilization of available information, in particular: information from trend reporting;
- The post-market surveillance plan shall cover at least: methods and protocols to manage the events subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
This raises a question: how can trend reporting be both an input and an output of the PMS system?
On one hand, the PMS plan is required to define methods and protocols to analyze PMS data in order to identify trends. In this context, trend reporting appears to be an output of the analysis process.
On the other hand, the regulation also states that information derived from trend reporting should be used as input within the PMS system.
How should these two aspects be practically reconciled? Should trend reporting be considered as part of a continuous feedback loop (with outputs feeding back as inputs), and how should this be reflected in the PMS plan?
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