How do companies handle MDR Annex III complaint investigation and market experience analysis?

Question

According to MDR 2017/745, Annex III, paragraph 1(b), manufacturers must implement effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field.
There is some ambiguity on how to meet this requirement. Specifically:
• Should all complaints be investigated and their root causes determined, or only those with certain risk levels?
• What methods or tools are considered acceptable for complaint investigation and market experience analysis?
• How are companies practically implementing these requirements in their PMS plans?

Any shared experiences or best practices would be helpful.

Dr. Oliver Eidel · Accepted Answer

We don't determine root causes for all feedback we get—only those that impact clinical safety, performance, or security. Our service team analyzes all incoming feedback (we use Zendesk to manage tickets), but only issues that are escalated as formal complaints get a root cause analysis. For other tickets, such as feature requests or minor bugs, we just document and track them.
This approach seems to be acceptable to our Notified Body, as long as we register and evaluate 100% of market feedback, and focus deeper investigations on higher-risk items.

Answer

I recommend describing your complaint handling process according to ISO 13485 (8.2.2), which already includes analysis of complaints and all feedback. For the PMS plan or report, you should carry out an overall analysis of the complaint data, such as classification, Pareto analysis, or trend identification. This can feed into your management review. For market experience, consider analyzing installation or service reports using similar methods.

How do companies handle MDR Annex III complaint investigation and market experience analysis?

3 Answers

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